Trial Outcomes & Findings for Neoadjuvant Accelerated Short Course Radiation Therapy With Photons and Capecitabine for Resectable Pancreatic Cancer (NCT NCT00889187)
NCT ID: NCT00889187
Last Updated: 2018-05-11
Results Overview
Neoadjuvant short-course photon radiation therapy MTD in combination with capecitabine 825 mg/m2 orally BID for ten consecutive weekdays, beginning on the morning of the first day of radiation therapy is determined by the number of patients who experience a dose limiting toxicity (DLT). See subsequent primary outcome measure for the DLT definition. The MTD is defined as the highest dose at which fewer than one-third of patients experience a DLT. If none of 3 initial patients or only 1 of 6 patients have a DLT on dose level 3 then 6 additional patients are treated at this dose. If during this expansion, the rate of DLT exceeds 30% then the next lower dose level is declared the MTD. If no DLTs are observed, the MTD is not reached.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
10 participants
Primary outcome timeframe
within 3 weeks of the start of chemoradiation therapy
Results posted on
2018-05-11
Participant Flow
Participants enrolled from Dec 2009 and Sep 2011.
Participant milestones
| Measure |
Phase 1 Cohort 1: Photon Rad (30 Gy/12 Days)+Capecitabine
Neoadjuvant Short-Course Photon Radiation:
At dose level 1, a total dose of 30 Gy in 10 fractions (3 Gy/day) was prescribed to the 95% isodose and administered 5 days per week over 12 days.
Chemotherapy:
Capecitabine was given orally 825 mg/m2 BID (total 1650 mg/m2 per day) for ten consecutive weekdays, beginning on the morning of the first day of radiation therapy.
Patients underwent resection of their pancreatic cancer 1-3 weeks after the completion of chemoradiation. It was recommended that patients undergoing R0 or R1 resections receive adjuvant treatment with 4-6 cycles of gemcitabine-based therapy per institutional policy, to start 4 to 10 weeks after the operation.
|
Phase I Cohort 2: Photon Rad (25 Gy/11 Days)+Capecitabine
Neoadjuvant Short-Course Photon Radiation:
At dose level 2, a total dose of 25 Gy in 5 fractions was prescribed to the 95% isodose and administered at 5 Gy per fraction over 11 days.
Chemotherapy:
Capecitabine was given orally 825 mg/m2 BID (total 1650 mg/m2 per day) for ten consecutive weekdays, beginning on the morning of the first day of radiation therapy.
Patients underwent resection of their pancreatic cancer 1-3 weeks after the completion of chemoradiation. It was recommended that patients undergoing R0 or R1 resections receive adjuvant treatment with 4-6 cycles of gemcitabine-based therapy per institutional policy, to start 4 to 10 weeks after the operation.
|
Phase I Cohort 3: Photon Rad (25 Gy/5 Days)+Capecitabine
Neoadjuvant Short-Course Photon Radiation:
At dose level 3, a total dose of 25 Gy in 5 fractions was prescribed to the 95% isodose and administered at 5 Gy per fraction over 5 days.
Chemotherapy:
Capecitabine was given orally 825 mg/m2 BID (total 1650 mg/m2 per day) for ten consecutive weekdays, beginning on the morning of the first day of radiation therapy.
Patients underwent resection of their pancreatic cancer 1-3 weeks after the completion of chemoradiation. It was recommended that patients undergoing R0 or R1 resections receive adjuvant treatment with 4-6 cycles of gemcitabine-based therapy per institutional policy, to start 4 to 10 weeks after the operation.
|
Phase II: Photon Rad (MTD)+Capecitabine
Neoadjuvant Short-Course Photon Radiation:
Phase II participants received the radiation regimen established in the Phase I study (MTD).
Chemotherapy:
Capecitabine was given orally 825 mg/m2 BID (total 1650 mg/m2 per day) for ten consecutive weekdays, beginning on the morning of the first day of radiation therapy.
Patients underwent resection of their pancreatic cancer 1-3 weeks after the completion of chemoradiation. It was recommended that patients undergoing R0 or R1 resections receive adjuvant treatment with 4-6 cycles of gemcitabine-based therapy per institutional policy, to start 4 to 10 weeks after the operation.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
4
|
0
|
|
Overall Study
COMPLETED
|
3
|
3
|
4
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Neoadjuvant Accelerated Short Course Radiation Therapy With Photons and Capecitabine for Resectable Pancreatic Cancer
Baseline characteristics by cohort
| Measure |
All Phase I: Photon Rad+Capecitabine
n=10 Participants
Neoadjuvant Short-Course Photon Radiation:
All Phase I participants received the radiation regimen according to the established dose escalation schedule.
Chemotherapy:
Capecitabine was given orally 825 mg/m2 BID (total 1650 mg/m2 per day) for ten consecutive weekdays, beginning on the morning of the first day of radiation therapy.
Patients underwent resection of their pancreatic cancer 1-3 weeks after the completion of chemoradiation. It was recommended that patients undergoing R0 or R1 resections receive adjuvant treatment with 4-6 cycles of gemcitabine-based therapy per institutional policy, to start 4 to 10 weeks after the operation.
|
|---|---|
|
Age, Continuous
|
62.6 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: within 3 weeks of the start of chemoradiation therapyPopulation: The analysis dataset is comprised of all treated patients.
Neoadjuvant short-course photon radiation therapy MTD in combination with capecitabine 825 mg/m2 orally BID for ten consecutive weekdays, beginning on the morning of the first day of radiation therapy is determined by the number of patients who experience a dose limiting toxicity (DLT). See subsequent primary outcome measure for the DLT definition. The MTD is defined as the highest dose at which fewer than one-third of patients experience a DLT. If none of 3 initial patients or only 1 of 6 patients have a DLT on dose level 3 then 6 additional patients are treated at this dose. If during this expansion, the rate of DLT exceeds 30% then the next lower dose level is declared the MTD. If no DLTs are observed, the MTD is not reached.
Outcome measures
| Measure |
All Phase I: Photon Rad+Capecitabine
n=10 Participants
Neoadjuvant Short-Course Photon Radiation:
All Phase I participants received the radiation regimen according to the established dose escalation schedule.
Chemotherapy:
Capecitabine was given orally 825 mg/m2 BID (total 1650 mg/m2 per day) for ten consecutive weekdays, beginning on the morning of the first day of radiation therapy.
Patients underwent resection of their pancreatic cancer 1-3 weeks after the completion of chemoradiation. It was recommended that patients undergoing R0 or R1 resections receive adjuvant treatment with 4-6 cycles of gemcitabine-based therapy per institutional policy, to start 4 to 10 weeks after the operation.
|
Phase I Cohort 2: Photon Rad (25 Gy/11 Days)+Capecitabine
Neoadjuvant Short-Course Photon Radiation:
At dose level 2, a total dose of 25 Gy in 5 fractions was prescribed to the 95% isodose and administered at 5 Gy per fraction over 11 days.
Chemotherapy:
Capecitabine was given orally 825 mg/m2 BID (total 1650 mg/m2 per day) for ten consecutive weekdays, beginning on the morning of the first day of radiation therapy.
Patients underwent resection of their pancreatic cancer 1-3 weeks after the completion of chemoradiation. It was recommended that patients undergoing R0 or R1 resections receive adjuvant treatment with 4-6 cycles of gemcitabine-based therapy per institutional policy, to start 4 to 10 weeks after the operation.
|
Phase I Cohort 3: Photon Rad (25 Gy/5 Days)+Capecitabine
Neoadjuvant Short-Course Photon Radiation:
At dose level 3, a total dose of 25 Gy in 5 fractions was prescribed to the 95% isodose and administered at 5 Gy per fraction over 5 days.
Chemotherapy:
Capecitabine was given orally 825 mg/m2 BID (total 1650 mg/m2 per day) for ten consecutive weekdays, beginning on the morning of the first day of radiation therapy.
Patients underwent resection of their pancreatic cancer 1-3 weeks after the completion of chemoradiation. It was recommended that patients undergoing R0 or R1 resections receive adjuvant treatment with 4-6 cycles of gemcitabine-based therapy per institutional policy, to start 4 to 10 weeks after the operation.
|
|---|---|---|---|
|
Neoadjuvant Short-Course Photon Radiation Therapy Maximum Tolerated Dose (MTD) [Phase I]
|
NA Gy per fraction
The study was closed early due to unexpected intraoperative complications. No patients developed a pre-specified DLT in the 10 treated patients. The MTD was not established.
|
—
|
—
|
PRIMARY outcome
Timeframe: within 3 weeks of the start of chemoradiation therapyPopulation: The analysis dataset is comprised of all treated patients.
DLT occurring within 3 weeks of the start of chemoradiation therapy was defined as: Grade 3 non-hematologic or hematologic toxicity requiring interruption of \>7 days (d) of chemo or \>3d chemoradiation; Grade 4 non-hematologic; Grade 4 neutropenia or thrombocytopenia; Treatment-related death; Delays in surgery \>3 weeks due to treatment-related toxicity. A 30% increase in any surgical complication rate beyond those previously established rates (readmission rate: 16%; pancreatic fistula/intra-abdominal abscess/infection rate: 27%, major intra-abdominal bleeding requiring return to OR: 1.6%, delayed gastric emptying: 4.4%, and superficial wound infection rate: 8%) was also considered a DLT.
Outcome measures
| Measure |
All Phase I: Photon Rad+Capecitabine
n=3 Participants
Neoadjuvant Short-Course Photon Radiation:
All Phase I participants received the radiation regimen according to the established dose escalation schedule.
Chemotherapy:
Capecitabine was given orally 825 mg/m2 BID (total 1650 mg/m2 per day) for ten consecutive weekdays, beginning on the morning of the first day of radiation therapy.
Patients underwent resection of their pancreatic cancer 1-3 weeks after the completion of chemoradiation. It was recommended that patients undergoing R0 or R1 resections receive adjuvant treatment with 4-6 cycles of gemcitabine-based therapy per institutional policy, to start 4 to 10 weeks after the operation.
|
Phase I Cohort 2: Photon Rad (25 Gy/11 Days)+Capecitabine
n=3 Participants
Neoadjuvant Short-Course Photon Radiation:
At dose level 2, a total dose of 25 Gy in 5 fractions was prescribed to the 95% isodose and administered at 5 Gy per fraction over 11 days.
Chemotherapy:
Capecitabine was given orally 825 mg/m2 BID (total 1650 mg/m2 per day) for ten consecutive weekdays, beginning on the morning of the first day of radiation therapy.
Patients underwent resection of their pancreatic cancer 1-3 weeks after the completion of chemoradiation. It was recommended that patients undergoing R0 or R1 resections receive adjuvant treatment with 4-6 cycles of gemcitabine-based therapy per institutional policy, to start 4 to 10 weeks after the operation.
|
Phase I Cohort 3: Photon Rad (25 Gy/5 Days)+Capecitabine
n=4 Participants
Neoadjuvant Short-Course Photon Radiation:
At dose level 3, a total dose of 25 Gy in 5 fractions was prescribed to the 95% isodose and administered at 5 Gy per fraction over 5 days.
Chemotherapy:
Capecitabine was given orally 825 mg/m2 BID (total 1650 mg/m2 per day) for ten consecutive weekdays, beginning on the morning of the first day of radiation therapy.
Patients underwent resection of their pancreatic cancer 1-3 weeks after the completion of chemoradiation. It was recommended that patients undergoing R0 or R1 resections receive adjuvant treatment with 4-6 cycles of gemcitabine-based therapy per institutional policy, to start 4 to 10 weeks after the operation.
|
|---|---|---|---|
|
Dose Limiting Toxicity (DLT) [Phase I]
|
0 patients with DLT
|
0 patients with DLT
|
0 patients with DLT
|
PRIMARY outcome
Timeframe: within 3 weeks of the start of chemoradiation therapyPopulation: The study did not proceed to phase II due to unexpected intraoperative complications experienced by patients enrolled on phase I.
All Grade 3-5 events based on CTCAEv3 related to the accelerated dose (attribution possible, probable, definite) as reported on case report forms.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Disease was assessed radiologically at baseline and after treatment every 6 months for first 2 years and annually in years 3-5.Population: The study did not proceed to phase II due to unexpected intraoperative complications experienced by patients enrolled on phase I.
Local recurrence rate is defined as the proportion of patients with evidence of tumor recurrence within the radiation field based on RECIST criteria. Per RECIST 1.0 for target lesions, PD is at least a 20% increase in sum LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or appearance of new lesions. For non-target lesions, PD is the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Assessed after resection; Patients underwent resection of their pancreatic cancer up to 3 weeks after completion of chemoradiation therapyPopulation: The study did not proceed to phase II due to unexpected intraoperative complications experienced by patients enrolled on phase I.
Pathologic response rate is the proportion of patients with the pathologic specimen absent any viable tumor cell. Pathological review of the pancreaticoduodenectomy specimen will be performed according to the AJCC Staging Classification, 6th edition. Initial gross evaluation and identification of resection margins will be performed jointly by the surgeon and the pathologist.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Disease was assessed radiologically at baseline and after treatment every 6 months for first 2 years and annually in years 3-5.Population: The study did not proceed to phase II due to unexpected intraoperative complications experienced by patients enrolled on phase I.
Progression-free survival based on the Kaplan-Meier method is defined as the duration of time from study entry to documented disease progression (PD) or death. Per RECIST 1.0 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions. Patients alive whose disease had not progressed are censored at date of last disease evaluation
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Assessed after resection; Patients underwent resection of their pancreatic cancer up to 3 weeks after completion of chemoradiation therapyPopulation: The study did not proceed to phase II due to unexpected intraoperative complications experienced by patients enrolled on phase I.
The proportion of patients experienced any grade 3-4 adverse event based on CTCAEv3 related to the surgery (attribution possible, probable, definite) as reported on case report forms.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Assessed up to 30 days after resection; Patients underwent resection of their pancreatic cancer up to 3 weeks after completion of chemoradiation therapyPopulation: The study did not proceed to phase II due to unexpected intraoperative complications experienced by patients enrolled on phase I.
The proportion of patients with a death related to the surgery (CTCAEv3 attribution possible, probable, definite).
Outcome measures
Outcome data not reported
Adverse Events
Phase 1 Cohort 1: Photon Rad (30 Gy/12 Days)+Capecitabine
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase I Cohort 2: Photon Rad (25 Gy/11 Days)+Capecitabine
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase I Cohort 3: Photon Rad (25 Gy/5 Days)+Capecitabine
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase 1 Cohort 1: Photon Rad (30 Gy/12 Days)+Capecitabine
n=3 participants at risk
Neoadjuvant Short-Course Photon Radiation:
At dose level 1, a total dose of 30 Gy in 10 fractions (3 Gy/day) was prescribed to the 95% isodose and administered 5 days per week over 12 days.
Chemotherapy:
Capecitabine was given orally 825 mg/m2 BID (total 1650 mg/m2 per day) for ten consecutive weekdays, beginning on the morning of the first day of radiation therapy.
Patients underwent resection of their pancreatic cancer 1-3 weeks after the completion of chemoradiation. It was recommended that patients undergoing R0 or R1 resections receive adjuvant treatment with 4-6 cycles of gemcitabine-based therapy per institutional policy, to start 4 to 10 weeks after the operation.
|
Phase I Cohort 2: Photon Rad (25 Gy/11 Days)+Capecitabine
n=3 participants at risk
Neoadjuvant Short-Course Photon Radiation:
At dose level 2, a total dose of 25 Gy in 5 fractions was prescribed to the 95% isodose and administered at 5 Gy per fraction over 11 days.
Chemotherapy:
Capecitabine was given orally 825 mg/m2 BID (total 1650 mg/m2 per day) for ten consecutive weekdays, beginning on the morning of the first day of radiation therapy.
Patients underwent resection of their pancreatic cancer 1-3 weeks after the completion of chemoradiation. It was recommended that patients undergoing R0 or R1 resections receive adjuvant treatment with 4-6 cycles of gemcitabine-based therapy per institutional policy, to start 4 to 10 weeks after the operation.
|
Phase I Cohort 3: Photon Rad (25 Gy/5 Days)+Capecitabine
n=4 participants at risk
Neoadjuvant Short-Course Photon Radiation:
At dose level 3, a total dose of 25 Gy in 5 fractions was prescribed to the 95% isodose and administered at 5 Gy per fraction over 5 days.
Chemotherapy:
Capecitabine was given orally 825 mg/m2 BID (total 1650 mg/m2 per day) for ten consecutive weekdays, beginning on the morning of the first day of radiation therapy.
Patients underwent resection of their pancreatic cancer 1-3 weeks after the completion of chemoradiation. It was recommended that patients undergoing R0 or R1 resections receive adjuvant treatment with 4-6 cycles of gemcitabine-based therapy per institutional policy, to start 4 to 10 weeks after the operation.
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
0.00%
0/3 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
0.00%
0/4 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
1/3 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
0.00%
0/3 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
0.00%
0/4 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
|
Investigations
Lymphopenia
|
33.3%
1/3 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
0.00%
0/3 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
0.00%
0/4 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
|
Infections and infestations
Infection-Other
|
0.00%
0/3 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
33.3%
1/3 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
0.00%
0/4 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
|
Gastrointestinal disorders
Hemorrhage/Bleeding-Other
|
0.00%
0/3 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
33.3%
1/3 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
0.00%
0/4 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
0.00%
0/3 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
0.00%
0/4 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
Other adverse events
| Measure |
Phase 1 Cohort 1: Photon Rad (30 Gy/12 Days)+Capecitabine
n=3 participants at risk
Neoadjuvant Short-Course Photon Radiation:
At dose level 1, a total dose of 30 Gy in 10 fractions (3 Gy/day) was prescribed to the 95% isodose and administered 5 days per week over 12 days.
Chemotherapy:
Capecitabine was given orally 825 mg/m2 BID (total 1650 mg/m2 per day) for ten consecutive weekdays, beginning on the morning of the first day of radiation therapy.
Patients underwent resection of their pancreatic cancer 1-3 weeks after the completion of chemoradiation. It was recommended that patients undergoing R0 or R1 resections receive adjuvant treatment with 4-6 cycles of gemcitabine-based therapy per institutional policy, to start 4 to 10 weeks after the operation.
|
Phase I Cohort 2: Photon Rad (25 Gy/11 Days)+Capecitabine
n=3 participants at risk
Neoadjuvant Short-Course Photon Radiation:
At dose level 2, a total dose of 25 Gy in 5 fractions was prescribed to the 95% isodose and administered at 5 Gy per fraction over 11 days.
Chemotherapy:
Capecitabine was given orally 825 mg/m2 BID (total 1650 mg/m2 per day) for ten consecutive weekdays, beginning on the morning of the first day of radiation therapy.
Patients underwent resection of their pancreatic cancer 1-3 weeks after the completion of chemoradiation. It was recommended that patients undergoing R0 or R1 resections receive adjuvant treatment with 4-6 cycles of gemcitabine-based therapy per institutional policy, to start 4 to 10 weeks after the operation.
|
Phase I Cohort 3: Photon Rad (25 Gy/5 Days)+Capecitabine
n=4 participants at risk
Neoadjuvant Short-Course Photon Radiation:
At dose level 3, a total dose of 25 Gy in 5 fractions was prescribed to the 95% isodose and administered at 5 Gy per fraction over 5 days.
Chemotherapy:
Capecitabine was given orally 825 mg/m2 BID (total 1650 mg/m2 per day) for ten consecutive weekdays, beginning on the morning of the first day of radiation therapy.
Patients underwent resection of their pancreatic cancer 1-3 weeks after the completion of chemoradiation. It was recommended that patients undergoing R0 or R1 resections receive adjuvant treatment with 4-6 cycles of gemcitabine-based therapy per institutional policy, to start 4 to 10 weeks after the operation.
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdomen, pain
|
33.3%
1/3 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
66.7%
2/3 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
50.0%
2/4 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
|
Investigations
Alkaline phosphatase
|
33.3%
1/3 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
0.00%
0/3 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
50.0%
2/4 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/3 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
33.3%
1/3 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
0.00%
0/4 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
|
Investigations
ALT, SGPT
|
33.3%
1/3 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
0.00%
0/3 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
75.0%
3/4 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
|
Metabolism and nutrition disorders
Anorexia
|
66.7%
2/3 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
33.3%
1/3 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
50.0%
2/4 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
33.3%
1/3 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
75.0%
3/4 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
|
Investigations
AST, SGOT
|
33.3%
1/3 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
0.00%
0/3 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
50.0%
2/4 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
|
Musculoskeletal and connective tissue disorders
Back, pain
|
0.00%
0/3 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
66.7%
2/3 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
0.00%
0/4 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
|
Investigations
Bilirubin
|
33.3%
1/3 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
0.00%
0/3 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
50.0%
2/4 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
33.3%
1/3 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
75.0%
3/4 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
|
Gastrointestinal disorders
Diarrhea w/o prior colostomy
|
0.00%
0/3 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
33.3%
1/3 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
0.00%
0/4 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
|
Gastrointestinal disorders
Distention/bloating, abdominal
|
0.00%
0/3 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
66.7%
2/3 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
0.00%
0/4 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
66.7%
2/3 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
0.00%
0/4 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
|
General disorders
Fatigue
|
33.3%
1/3 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
100.0%
3/3 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
75.0%
3/4 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
|
General disorders
Fever w/o neutropenia
|
66.7%
2/3 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
0.00%
0/3 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
0.00%
0/4 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
0.00%
0/3 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
33.3%
1/3 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
25.0%
1/4 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/3 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
0.00%
0/3 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
25.0%
1/4 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
33.3%
1/3 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
66.7%
2/3 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
25.0%
1/4 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/3 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
0.00%
0/3 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
25.0%
1/4 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/3 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
0.00%
0/3 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
25.0%
1/4 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/3 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
33.3%
1/3 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
0.00%
0/4 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
33.3%
1/3 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
0.00%
0/3 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
0.00%
0/4 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
66.7%
2/3 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
0.00%
0/3 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
25.0%
1/4 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
33.3%
1/3 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
33.3%
1/3 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
0.00%
0/4 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
0.00%
0/3 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
25.0%
1/4 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
|
Investigations
Leukocytes
|
0.00%
0/3 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
33.3%
1/3 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
25.0%
1/4 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
|
Investigations
Lymphopenia
|
66.7%
2/3 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
66.7%
2/3 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
100.0%
4/4 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
100.0%
3/3 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
75.0%
3/4 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
|
General disorders
Pain-other
|
0.00%
0/3 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
33.3%
1/3 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
0.00%
0/4 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
|
Gastrointestinal disorders
Perforation, cecum
|
0.00%
0/3 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
33.3%
1/3 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
0.00%
0/4 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
|
Investigations
Platelets
|
0.00%
0/3 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
0.00%
0/3 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
50.0%
2/4 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
0.00%
0/3 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
0.00%
0/3 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
25.0%
1/4 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
0.00%
0/3 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
0.00%
0/3 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
25.0%
1/4 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
|
Gastrointestinal disorders
Stomach, pain
|
0.00%
0/3 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
33.3%
1/3 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
0.00%
0/4 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
|
Renal and urinary disorders
Urine color
|
0.00%
0/3 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
0.00%
0/3 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
25.0%
1/4 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
33.3%
1/3 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
50.0%
2/4 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
|
Investigations
Weight loss
|
33.3%
1/3 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
0.00%
0/3 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
0.00%
0/4 • Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
|
Additional Information
Harvey Mamon, MD, PhD
Brigham and Women's Hospital / Dana Farber Cancer Institute
Phone: 617-732-8564
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place