Trial Outcomes & Findings for FDG-PET Directed Treatment in Improving Response in Patients With Locally Advanced Stomach or Gastroesophageal Junction Cancer (NCT NCT02485834)
NCT ID: NCT02485834
Last Updated: 2025-01-20
Results Overview
Overall survival is defined as the time from date of randomization to death due to any cause.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
5 participants
Primary outcome timeframe
Up to 3 years
Results posted on
2025-01-20
Participant Flow
Pre-randomization events included: 1) Baseline FDG-PET scan 2) Pre-registration 3) Second FDG-PET scan. Screen failures excluded from the study before randomization consisted of ineligible patients (n = 13), investigator decision (n = 1), and other screen failure reason (n=1).
Participant milestones
| Measure |
Arm A - Surgery, Chemotherapy and Radiation Therapy
Patients undergo surgery within 42 days of completion of pre-registration chemotherapy. Beginning within 49 days of surgery, patients receive 5-FU IV continuously and capecitabine PO BID on days 1-7, and undergo 3D-CRT or IMRT QD on days 1-5. Treatment continues for 5 weeks in the absence of disease progression or unacceptable toxicity.
|
Arm B - Surgery, Chemotherapy and FDG-PET
Beginning within 28 days of day 1 of pre-registration chemotherapy, patients receive docetaxel IV and irinotecan IV on days 1 and 8. Treatment repeats every 3 weeks for 2 courses. Beginning within 42 days of completion of docetaxel and irinotecan, patients undergo surgery. Patients also undergo FDG-PET within 14 days of planned surgery. Beginning within 60 days after surgery, patients receive 3 additional courses of docetaxel and irinotecan hydrochloride courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
2
|
|
Overall Study
COMPLETED
|
3
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
FDG-PET Directed Treatment in Improving Response in Patients With Locally Advanced Stomach or Gastroesophageal Junction Cancer
Baseline characteristics by cohort
| Measure |
Randomized Patients
n=5 Participants
Patients on Arms A and B as detailed in the Participant Flow are summarized.
|
|---|---|
|
Age, Continuous
|
61.4 years
STANDARD_DEVIATION 7.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
|
ECOG Performance Status
0
|
3 Participants
n=5 Participants
|
|
ECOG Performance Status
1
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 3 yearsPopulation: Due to small numbers, overall results are summarized across all randomized patients to protect patient confidentiality.
Overall survival is defined as the time from date of randomization to death due to any cause.
Outcome measures
| Measure |
Randomized Patients
n=5 Participants
Patients on Arms A and B as detailed in the Participant Flow are summarized.
|
|---|---|
|
Overall Survival
|
NA months
Interval 11.07 to
Not all patients have observed event of interest (i.e. death); thus the median and upper 95% confidence interval limit are not available.
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: Due to small numbers, overall results are summarized across all randomized patients to protect patient confidentiality.
Progression free survival (PFS) is defined as the time from the date of randomization to the date of disease progression or death resulting from any cause, whichever comes first. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.
Outcome measures
| Measure |
Randomized Patients
n=5 Participants
Patients on Arms A and B as detailed in the Participant Flow are summarized.
|
|---|---|
|
Progression-free Survival
|
NA months
Interval 0.62 to
Not all patients have observed event of interest (i.e. death/progression); thus the median and upper 95% confidence interval limit are not available.
|
SECONDARY outcome
Timeframe: At time of surgeryPopulation: Due to small numbers, overall results are summarized across all randomized patients to protect patient confidentiality.
The number of patients achieved R0 resection during surgery
Outcome measures
| Measure |
Randomized Patients
n=5 Participants
Patients on Arms A and B as detailed in the Participant Flow are summarized.
|
|---|---|
|
Number of Patients Achieved R0 Resection During Surgery
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: Due to small numbers, overall results are summarized across all randomized patients to protect patient confidentiality.
The number of patients had pathologic complete response (pCR). (pCR is defined as no gross or microscopic tumor identified with the surgical specimen. All lymph nodes should be free of tumor to document a PCR. If no gross tumor is visible, section around the area of inflammation (nodularity) should be made every 2-3 cm and specimens examined.)
Outcome measures
| Measure |
Randomized Patients
n=5 Participants
Patients on Arms A and B as detailed in the Participant Flow are summarized.
|
|---|---|
|
Number of Patients Had Pathologic Complete Response
|
4 Participants
|
SECONDARY outcome
Timeframe: Up to 30 days after completion of protocol treatmentPopulation: Only patients who received treatment and were assessed for adverse events and completed the adverse events form were included in this analysis.
The number of patients who reported grade 3 or higher Adverse Events according to Common Terminology Criteria for Adverse Events version 4.0.
Outcome measures
| Measure |
Randomized Patients
n=4 Participants
Patients on Arms A and B as detailed in the Participant Flow are summarized.
|
|---|---|
|
Number of Participants Who Reported Grade 3 or Higher Adverse Events
|
3 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 14 days prior to surgeryOutcome measures
Outcome data not reported
Adverse Events
Arm A - Surgery, Chemotherapy and Radiation Therapy
Serious events: 2 serious events
Other events: 0 other events
Deaths: 1 deaths
Arm B - Surgery, Chemotherapy and FDG-PET
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A - Surgery, Chemotherapy and Radiation Therapy
n=2 participants at risk
Patients undergo surgery within 42 days of completion of pre-registration chemotherapy. Beginning within 49 days of surgery, patients receive 5-FU IV continuously and capecitabine PO BID on days 1-7, and undergo 3D-CRT or IMRT QD on days 1-5. Treatment continues for 5 weeks in the absence of disease progression or unacceptable toxicity.
|
Arm B - Surgery, Chemotherapy and FDG-PET
n=2 participants at risk
Beginning within 28 days of day 1 of pre-registration chemotherapy, patients receive docetaxel IV and irinotecan IV on days 1 and 8. Treatment repeats every 3 weeks for 2 courses. Beginning within 42 days of completion of docetaxel and irinotecan, patients undergo surgery. Patients also undergo FDG-PET within 14 days of planned surgery. Beginning within 60 days after surgery, patients receive 3 additional courses of docetaxel and irinotecan hydrochloride courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
50.0%
1/2 • Number of events 1 • Adverse events are assessed prior to pre-registration, prior to registration, on day 1 of weeks 1 and 4 of chemo-radiation therapy for Arm A patients, on day 1 of each cycle (pre ad post-surgery) for Arm B patients, and prior to surgery for Arm A and B patients; Up to 30 days after completion of protocol treatment
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients assessed for AEs and completed AE form. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/2 • Adverse events are assessed prior to pre-registration, prior to registration, on day 1 of weeks 1 and 4 of chemo-radiation therapy for Arm A patients, on day 1 of each cycle (pre ad post-surgery) for Arm B patients, and prior to surgery for Arm A and B patients; Up to 30 days after completion of protocol treatment
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients assessed for AEs and completed AE form. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Gastrointestinal disorders
Abdominal pain
|
50.0%
1/2 • Number of events 1 • Adverse events are assessed prior to pre-registration, prior to registration, on day 1 of weeks 1 and 4 of chemo-radiation therapy for Arm A patients, on day 1 of each cycle (pre ad post-surgery) for Arm B patients, and prior to surgery for Arm A and B patients; Up to 30 days after completion of protocol treatment
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients assessed for AEs and completed AE form. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/2 • Adverse events are assessed prior to pre-registration, prior to registration, on day 1 of weeks 1 and 4 of chemo-radiation therapy for Arm A patients, on day 1 of each cycle (pre ad post-surgery) for Arm B patients, and prior to surgery for Arm A and B patients; Up to 30 days after completion of protocol treatment
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients assessed for AEs and completed AE form. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Gastrointestinal disorders
Dysphagia
|
50.0%
1/2 • Number of events 1 • Adverse events are assessed prior to pre-registration, prior to registration, on day 1 of weeks 1 and 4 of chemo-radiation therapy for Arm A patients, on day 1 of each cycle (pre ad post-surgery) for Arm B patients, and prior to surgery for Arm A and B patients; Up to 30 days after completion of protocol treatment
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients assessed for AEs and completed AE form. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/2 • Adverse events are assessed prior to pre-registration, prior to registration, on day 1 of weeks 1 and 4 of chemo-radiation therapy for Arm A patients, on day 1 of each cycle (pre ad post-surgery) for Arm B patients, and prior to surgery for Arm A and B patients; Up to 30 days after completion of protocol treatment
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients assessed for AEs and completed AE form. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
50.0%
1/2 • Number of events 1 • Adverse events are assessed prior to pre-registration, prior to registration, on day 1 of weeks 1 and 4 of chemo-radiation therapy for Arm A patients, on day 1 of each cycle (pre ad post-surgery) for Arm B patients, and prior to surgery for Arm A and B patients; Up to 30 days after completion of protocol treatment
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients assessed for AEs and completed AE form. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/2 • Adverse events are assessed prior to pre-registration, prior to registration, on day 1 of weeks 1 and 4 of chemo-radiation therapy for Arm A patients, on day 1 of each cycle (pre ad post-surgery) for Arm B patients, and prior to surgery for Arm A and B patients; Up to 30 days after completion of protocol treatment
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients assessed for AEs and completed AE form. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Gastrointestinal disorders
Jejunal obstruction
|
50.0%
1/2 • Number of events 1 • Adverse events are assessed prior to pre-registration, prior to registration, on day 1 of weeks 1 and 4 of chemo-radiation therapy for Arm A patients, on day 1 of each cycle (pre ad post-surgery) for Arm B patients, and prior to surgery for Arm A and B patients; Up to 30 days after completion of protocol treatment
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients assessed for AEs and completed AE form. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/2 • Adverse events are assessed prior to pre-registration, prior to registration, on day 1 of weeks 1 and 4 of chemo-radiation therapy for Arm A patients, on day 1 of each cycle (pre ad post-surgery) for Arm B patients, and prior to surgery for Arm A and B patients; Up to 30 days after completion of protocol treatment
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients assessed for AEs and completed AE form. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Gastrointestinal disorders
Nausea
|
100.0%
2/2 • Number of events 2 • Adverse events are assessed prior to pre-registration, prior to registration, on day 1 of weeks 1 and 4 of chemo-radiation therapy for Arm A patients, on day 1 of each cycle (pre ad post-surgery) for Arm B patients, and prior to surgery for Arm A and B patients; Up to 30 days after completion of protocol treatment
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients assessed for AEs and completed AE form. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/2 • Adverse events are assessed prior to pre-registration, prior to registration, on day 1 of weeks 1 and 4 of chemo-radiation therapy for Arm A patients, on day 1 of each cycle (pre ad post-surgery) for Arm B patients, and prior to surgery for Arm A and B patients; Up to 30 days after completion of protocol treatment
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients assessed for AEs and completed AE form. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
General disorders
Fatigue
|
100.0%
2/2 • Number of events 2 • Adverse events are assessed prior to pre-registration, prior to registration, on day 1 of weeks 1 and 4 of chemo-radiation therapy for Arm A patients, on day 1 of each cycle (pre ad post-surgery) for Arm B patients, and prior to surgery for Arm A and B patients; Up to 30 days after completion of protocol treatment
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients assessed for AEs and completed AE form. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/2 • Adverse events are assessed prior to pre-registration, prior to registration, on day 1 of weeks 1 and 4 of chemo-radiation therapy for Arm A patients, on day 1 of each cycle (pre ad post-surgery) for Arm B patients, and prior to surgery for Arm A and B patients; Up to 30 days after completion of protocol treatment
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients assessed for AEs and completed AE form. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Investigations
Weight loss
|
50.0%
1/2 • Number of events 1 • Adverse events are assessed prior to pre-registration, prior to registration, on day 1 of weeks 1 and 4 of chemo-radiation therapy for Arm A patients, on day 1 of each cycle (pre ad post-surgery) for Arm B patients, and prior to surgery for Arm A and B patients; Up to 30 days after completion of protocol treatment
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients assessed for AEs and completed AE form. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/2 • Adverse events are assessed prior to pre-registration, prior to registration, on day 1 of weeks 1 and 4 of chemo-radiation therapy for Arm A patients, on day 1 of each cycle (pre ad post-surgery) for Arm B patients, and prior to surgery for Arm A and B patients; Up to 30 days after completion of protocol treatment
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients assessed for AEs and completed AE form. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Metabolism and nutrition disorders
Anorexia
|
50.0%
1/2 • Number of events 1 • Adverse events are assessed prior to pre-registration, prior to registration, on day 1 of weeks 1 and 4 of chemo-radiation therapy for Arm A patients, on day 1 of each cycle (pre ad post-surgery) for Arm B patients, and prior to surgery for Arm A and B patients; Up to 30 days after completion of protocol treatment
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients assessed for AEs and completed AE form. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/2 • Adverse events are assessed prior to pre-registration, prior to registration, on day 1 of weeks 1 and 4 of chemo-radiation therapy for Arm A patients, on day 1 of each cycle (pre ad post-surgery) for Arm B patients, and prior to surgery for Arm A and B patients; Up to 30 days after completion of protocol treatment
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients assessed for AEs and completed AE form. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
50.0%
1/2 • Number of events 1 • Adverse events are assessed prior to pre-registration, prior to registration, on day 1 of weeks 1 and 4 of chemo-radiation therapy for Arm A patients, on day 1 of each cycle (pre ad post-surgery) for Arm B patients, and prior to surgery for Arm A and B patients; Up to 30 days after completion of protocol treatment
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients assessed for AEs and completed AE form. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/2 • Adverse events are assessed prior to pre-registration, prior to registration, on day 1 of weeks 1 and 4 of chemo-radiation therapy for Arm A patients, on day 1 of each cycle (pre ad post-surgery) for Arm B patients, and prior to surgery for Arm A and B patients; Up to 30 days after completion of protocol treatment
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients assessed for AEs and completed AE form. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Psychiatric disorders
Anxiety
|
50.0%
1/2 • Number of events 1 • Adverse events are assessed prior to pre-registration, prior to registration, on day 1 of weeks 1 and 4 of chemo-radiation therapy for Arm A patients, on day 1 of each cycle (pre ad post-surgery) for Arm B patients, and prior to surgery for Arm A and B patients; Up to 30 days after completion of protocol treatment
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients assessed for AEs and completed AE form. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/2 • Adverse events are assessed prior to pre-registration, prior to registration, on day 1 of weeks 1 and 4 of chemo-radiation therapy for Arm A patients, on day 1 of each cycle (pre ad post-surgery) for Arm B patients, and prior to surgery for Arm A and B patients; Up to 30 days after completion of protocol treatment
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients assessed for AEs and completed AE form. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
Other adverse events
| Measure |
Arm A - Surgery, Chemotherapy and Radiation Therapy
n=2 participants at risk
Patients undergo surgery within 42 days of completion of pre-registration chemotherapy. Beginning within 49 days of surgery, patients receive 5-FU IV continuously and capecitabine PO BID on days 1-7, and undergo 3D-CRT or IMRT QD on days 1-5. Treatment continues for 5 weeks in the absence of disease progression or unacceptable toxicity.
|
Arm B - Surgery, Chemotherapy and FDG-PET
n=2 participants at risk
Beginning within 28 days of day 1 of pre-registration chemotherapy, patients receive docetaxel IV and irinotecan IV on days 1 and 8. Treatment repeats every 3 weeks for 2 courses. Beginning within 42 days of completion of docetaxel and irinotecan, patients undergo surgery. Patients also undergo FDG-PET within 14 days of planned surgery. Beginning within 60 days after surgery, patients receive 3 additional courses of docetaxel and irinotecan hydrochloride courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/2 • Adverse events are assessed prior to pre-registration, prior to registration, on day 1 of weeks 1 and 4 of chemo-radiation therapy for Arm A patients, on day 1 of each cycle (pre ad post-surgery) for Arm B patients, and prior to surgery for Arm A and B patients; Up to 30 days after completion of protocol treatment
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients assessed for AEs and completed AE form. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
100.0%
2/2 • Number of events 2 • Adverse events are assessed prior to pre-registration, prior to registration, on day 1 of weeks 1 and 4 of chemo-radiation therapy for Arm A patients, on day 1 of each cycle (pre ad post-surgery) for Arm B patients, and prior to surgery for Arm A and B patients; Up to 30 days after completion of protocol treatment
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients assessed for AEs and completed AE form. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/2 • Adverse events are assessed prior to pre-registration, prior to registration, on day 1 of weeks 1 and 4 of chemo-radiation therapy for Arm A patients, on day 1 of each cycle (pre ad post-surgery) for Arm B patients, and prior to surgery for Arm A and B patients; Up to 30 days after completion of protocol treatment
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients assessed for AEs and completed AE form. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
50.0%
1/2 • Number of events 1 • Adverse events are assessed prior to pre-registration, prior to registration, on day 1 of weeks 1 and 4 of chemo-radiation therapy for Arm A patients, on day 1 of each cycle (pre ad post-surgery) for Arm B patients, and prior to surgery for Arm A and B patients; Up to 30 days after completion of protocol treatment
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients assessed for AEs and completed AE form. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/2 • Adverse events are assessed prior to pre-registration, prior to registration, on day 1 of weeks 1 and 4 of chemo-radiation therapy for Arm A patients, on day 1 of each cycle (pre ad post-surgery) for Arm B patients, and prior to surgery for Arm A and B patients; Up to 30 days after completion of protocol treatment
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients assessed for AEs and completed AE form. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
50.0%
1/2 • Number of events 1 • Adverse events are assessed prior to pre-registration, prior to registration, on day 1 of weeks 1 and 4 of chemo-radiation therapy for Arm A patients, on day 1 of each cycle (pre ad post-surgery) for Arm B patients, and prior to surgery for Arm A and B patients; Up to 30 days after completion of protocol treatment
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients assessed for AEs and completed AE form. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/2 • Adverse events are assessed prior to pre-registration, prior to registration, on day 1 of weeks 1 and 4 of chemo-radiation therapy for Arm A patients, on day 1 of each cycle (pre ad post-surgery) for Arm B patients, and prior to surgery for Arm A and B patients; Up to 30 days after completion of protocol treatment
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients assessed for AEs and completed AE form. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
50.0%
1/2 • Number of events 1 • Adverse events are assessed prior to pre-registration, prior to registration, on day 1 of weeks 1 and 4 of chemo-radiation therapy for Arm A patients, on day 1 of each cycle (pre ad post-surgery) for Arm B patients, and prior to surgery for Arm A and B patients; Up to 30 days after completion of protocol treatment
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients assessed for AEs and completed AE form. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
General disorders
Fatigue
|
0.00%
0/2 • Adverse events are assessed prior to pre-registration, prior to registration, on day 1 of weeks 1 and 4 of chemo-radiation therapy for Arm A patients, on day 1 of each cycle (pre ad post-surgery) for Arm B patients, and prior to surgery for Arm A and B patients; Up to 30 days after completion of protocol treatment
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients assessed for AEs and completed AE form. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
100.0%
2/2 • Number of events 3 • Adverse events are assessed prior to pre-registration, prior to registration, on day 1 of weeks 1 and 4 of chemo-radiation therapy for Arm A patients, on day 1 of each cycle (pre ad post-surgery) for Arm B patients, and prior to surgery for Arm A and B patients; Up to 30 days after completion of protocol treatment
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients assessed for AEs and completed AE form. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/2 • Adverse events are assessed prior to pre-registration, prior to registration, on day 1 of weeks 1 and 4 of chemo-radiation therapy for Arm A patients, on day 1 of each cycle (pre ad post-surgery) for Arm B patients, and prior to surgery for Arm A and B patients; Up to 30 days after completion of protocol treatment
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients assessed for AEs and completed AE form. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
50.0%
1/2 • Number of events 1 • Adverse events are assessed prior to pre-registration, prior to registration, on day 1 of weeks 1 and 4 of chemo-radiation therapy for Arm A patients, on day 1 of each cycle (pre ad post-surgery) for Arm B patients, and prior to surgery for Arm A and B patients; Up to 30 days after completion of protocol treatment
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients assessed for AEs and completed AE form. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/2 • Adverse events are assessed prior to pre-registration, prior to registration, on day 1 of weeks 1 and 4 of chemo-radiation therapy for Arm A patients, on day 1 of each cycle (pre ad post-surgery) for Arm B patients, and prior to surgery for Arm A and B patients; Up to 30 days after completion of protocol treatment
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients assessed for AEs and completed AE form. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
50.0%
1/2 • Number of events 1 • Adverse events are assessed prior to pre-registration, prior to registration, on day 1 of weeks 1 and 4 of chemo-radiation therapy for Arm A patients, on day 1 of each cycle (pre ad post-surgery) for Arm B patients, and prior to surgery for Arm A and B patients; Up to 30 days after completion of protocol treatment
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients assessed for AEs and completed AE form. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
Additional Information
Manish A. Shah MD
Weill Medical College of Cornell University
Phone: 646-962-6200
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place