Trial Outcomes & Findings for Neoadjuvant Chemoradiotherapy and Adjuvant Chemotherapy in Treating Patients Who Are Undergoing Surgical Resection for Locally Advanced Rectal Cancer (NCT NCT00081289)
NCT ID: NCT00081289
Last Updated: 2020-02-27
Results Overview
A pathologic complete response (pCR) was defined as no evidence of residual cancer histologically; disease progression or death before surgery was considered less than pCR (even without surgical specimen). All cases were reviewed by the study's surgical oncology co-chair for the determination of pCR. Each arm was first analyzed alone. If the arm had 9 or more pCRs in 48 evaluable pts, then the null hypothesis (H0) of 10% pCR rate would be rejected in favor of the alternative hypothesis of 25%, providing 90% power with a two-sided 10% type I error rate. If both arms reject H0, then statistical selection theory would be used to choose the arm for further study in a phase III trial. If only one arm has acceptable pCR rate, then that arm would be pursued in a phase III trial.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
146 participants
Primary outcome timeframe
After protocol surgery, approximately 10-16 weeks from randomization based on surgery occurring 4-8 weeks after chemoradiation
Results posted on
2020-02-27
Participant Flow
Participant milestones
| Measure |
Neoadjuvant Chemoradiation With Irinotecan
Patients receive neoadjuvant therapy comprising radiotherapy (RT), 1200mg/m2/day oral capecitabine and irinotecan. Surgery 4-8 weeks after RT. Postoperative chemotherapy (folinic acid, fluorouracil, and oxaliplatin) 4-6 weeks after surgery.
|
Neoadjuvant Chemoradiation With Oxaliplatin
Patients receive neoadjuvant therapy comprising radiotherapy, 1650mg/m2/day oral capecitabine and oxaliplatin. Surgery 4-8 weeks after RT. Postoperative chemotherapy (folinic acid, fluorouracil, and oxaliplatin) 4-6 weeks after surgery.
|
|---|---|---|
|
Overall Study
STARTED
|
73
|
73
|
|
Overall Study
Primary Endpoint Population
|
48
|
48
|
|
Overall Study
General Analysis Population
|
52
|
52
|
|
Overall Study
Full AE Population
|
70
|
68
|
|
Overall Study
Surgery
|
47
|
51
|
|
Overall Study
Global Health Status Score at End of CR
|
34
|
32
|
|
Overall Study
GHS at End of Post-op CT
|
20
|
28
|
|
Overall Study
GHS at Two Years
|
21
|
20
|
|
Overall Study
GI Symptom Score at End of CR
|
34
|
33
|
|
Overall Study
GI Symptom Score at End of Post-op CT
|
22
|
27
|
|
Overall Study
GI Symptom Score at Two Years
|
21
|
20
|
|
Overall Study
Defecation Symptom Score at End of CR
|
32
|
32
|
|
Overall Study
DS Score at End of Post-op CT
|
12
|
14
|
|
Overall Study
Defecation Symptom Score at Two Years
|
13
|
15
|
|
Overall Study
COMPLETED
|
52
|
52
|
|
Overall Study
NOT COMPLETED
|
21
|
21
|
Reasons for withdrawal
| Measure |
Neoadjuvant Chemoradiation With Irinotecan
Patients receive neoadjuvant therapy comprising radiotherapy (RT), 1200mg/m2/day oral capecitabine and irinotecan. Surgery 4-8 weeks after RT. Postoperative chemotherapy (folinic acid, fluorouracil, and oxaliplatin) 4-6 weeks after surgery.
|
Neoadjuvant Chemoradiation With Oxaliplatin
Patients receive neoadjuvant therapy comprising radiotherapy, 1650mg/m2/day oral capecitabine and oxaliplatin. Surgery 4-8 weeks after RT. Postoperative chemotherapy (folinic acid, fluorouracil, and oxaliplatin) 4-6 weeks after surgery.
|
|---|---|---|
|
Overall Study
Accrued prior to chemotherapy amendment
|
18
|
17
|
|
Overall Study
Ineligible / no protocol treatment
|
3
|
4
|
Baseline Characteristics
Neoadjuvant Chemoradiotherapy and Adjuvant Chemotherapy in Treating Patients Who Are Undergoing Surgical Resection for Locally Advanced Rectal Cancer
Baseline characteristics by cohort
| Measure |
Neoadjuvant Chemoradiation With Irinotecan
n=52 Participants
Patients receive neoadjuvant therapy comprising radiotherapy, 1200mg/m2/day oral capecitabine and irinotecan. Surgery 4-8 weeks after RT. Postoperative chemotherapy (folinic acid, fluorouracil, and oxaliplatin) 4-6 weeks after surgery.
|
Neoadjuvant Chemoradiation With Oxaliplatin
n=52 Participants
Patients receive neoadjuvant therapy comprising radiotherapy, 1650mg/m2/day oral capecitabine and oxaliplatin. Surgery 4-8 weeks after RT. Postoperative chemotherapy (folinic acid, fluorouracil, and oxaliplatin) 4-6 weeks after surgery.
|
Total
n=104 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57 years
n=93 Participants
|
56 years
n=4 Participants
|
57 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
33 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=93 Participants
|
38 Participants
n=4 Participants
|
71 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: After protocol surgery, approximately 10-16 weeks from randomization based on surgery occurring 4-8 weeks after chemoradiationPopulation: For each arm the first 48 eligible enrolled after the protocol amendment.
A pathologic complete response (pCR) was defined as no evidence of residual cancer histologically; disease progression or death before surgery was considered less than pCR (even without surgical specimen). All cases were reviewed by the study's surgical oncology co-chair for the determination of pCR. Each arm was first analyzed alone. If the arm had 9 or more pCRs in 48 evaluable pts, then the null hypothesis (H0) of 10% pCR rate would be rejected in favor of the alternative hypothesis of 25%, providing 90% power with a two-sided 10% type I error rate. If both arms reject H0, then statistical selection theory would be used to choose the arm for further study in a phase III trial. If only one arm has acceptable pCR rate, then that arm would be pursued in a phase III trial.
Outcome measures
| Measure |
Neoadjuvant Chemoradiation With Irinotecan
n=48 Participants
Patients receive neoadjuvant therapy comprising radiotherapy, 1200mg/m2/day oral capecitabine and irinotecan. Surgery 4-8 weeks after RT. Postoperative chemotherapy (folinic acid, fluorouracil, and oxaliplatin) 4-6 weeks after surgery.
|
Neoadjuvant Chemoradiation With Oxaliplatin
n=48 Participants
Patients receive neoadjuvant therapy comprising radiotherapy, 1650mg/m2/day oral capecitabine and oxaliplatin. Surgery 4-8 weeks after RT. Postoperative chemotherapy (folinic acid, fluorouracil, and oxaliplatin) 4-6 weeks after surgery.
|
|---|---|---|
|
Pathologic Complete Response Rate
|
10.4 percentage of participants
Interval 3.5 to 22.7
|
20.8 percentage of participants
Interval 10.5 to 35.0
|
SECONDARY outcome
Timeframe: From randomization to four yearsPopulation: Eligible patients enrolled after the protocol amendment
Survival time is defined as time from registration/randomization to the date of death from any cause or last known follow-up (censored). Survival rates are estimated by the Kaplan-Meier method.
Outcome measures
| Measure |
Neoadjuvant Chemoradiation With Irinotecan
n=52 Participants
Patients receive neoadjuvant therapy comprising radiotherapy, 1200mg/m2/day oral capecitabine and irinotecan. Surgery 4-8 weeks after RT. Postoperative chemotherapy (folinic acid, fluorouracil, and oxaliplatin) 4-6 weeks after surgery.
|
Neoadjuvant Chemoradiation With Oxaliplatin
n=52 Participants
Patients receive neoadjuvant therapy comprising radiotherapy, 1650mg/m2/day oral capecitabine and oxaliplatin. Surgery 4-8 weeks after RT. Postoperative chemotherapy (folinic acid, fluorouracil, and oxaliplatin) 4-6 weeks after surgery.
|
|---|---|---|
|
Survival Rate at 4 Years
|
85 percentage of participants
Interval 66.0 to 94.0
|
75 percentage of participants
Interval 60.0 to 85.0
|
SECONDARY outcome
Timeframe: From randomization to four yearsPopulation: Eligible patients enrolled after the protocol amendment
Local-regional failure is defined as any of the following: no clinical complete response (cCR) in the primary site and/or nodes at any time after treatment completion (persistence), recurrence and/or progression in the primary site and/or nodes after cCR, and nonprotocol surgery to the primary site after cCR. Time to local-regional failure is defined as time from randomization to date of failure, last known follow-up (censored), or death without local-regional failure (competing risk). Local-regional failure rates are estimated by the cumulative incidence method.
Outcome measures
| Measure |
Neoadjuvant Chemoradiation With Irinotecan
n=52 Participants
Patients receive neoadjuvant therapy comprising radiotherapy, 1200mg/m2/day oral capecitabine and irinotecan. Surgery 4-8 weeks after RT. Postoperative chemotherapy (folinic acid, fluorouracil, and oxaliplatin) 4-6 weeks after surgery.
|
Neoadjuvant Chemoradiation With Oxaliplatin
n=52 Participants
Patients receive neoadjuvant therapy comprising radiotherapy, 1650mg/m2/day oral capecitabine and oxaliplatin. Surgery 4-8 weeks after RT. Postoperative chemotherapy (folinic acid, fluorouracil, and oxaliplatin) 4-6 weeks after surgery.
|
|---|---|---|
|
Local-regional Failure Rate at 4 Years
|
16 percentage of participants
Interval 6.0 to 27.0
|
18 percentage of participants
Interval 7.0 to 28.0
|
SECONDARY outcome
Timeframe: From randomization to four yearsPopulation: Eligible patients enrolled after the protocol amendment
Time to distant failure is defined as time from randomization to date of the appearance of distant metastases, last known follow-up (censored), or death without distant failure (competing risk). Distant failure rates are estimated by the cumulative incidence method.
Outcome measures
| Measure |
Neoadjuvant Chemoradiation With Irinotecan
n=52 Participants
Patients receive neoadjuvant therapy comprising radiotherapy, 1200mg/m2/day oral capecitabine and irinotecan. Surgery 4-8 weeks after RT. Postoperative chemotherapy (folinic acid, fluorouracil, and oxaliplatin) 4-6 weeks after surgery.
|
Neoadjuvant Chemoradiation With Oxaliplatin
n=52 Participants
Patients receive neoadjuvant therapy comprising radiotherapy, 1650mg/m2/day oral capecitabine and oxaliplatin. Surgery 4-8 weeks after RT. Postoperative chemotherapy (folinic acid, fluorouracil, and oxaliplatin) 4-6 weeks after surgery.
|
|---|---|---|
|
Distant Failure Rate at 4 Years
|
24 percentage of participants
Interval 11.0 to 38.0
|
30 percentage of participants
Interval 17.0 to 43.0
|
SECONDARY outcome
Timeframe: From randomization to four yearsPopulation: Eligible patients enrolled after the protocol amendment
Time to second primary is defined as time from randomization to date of the appearance of a second primary cancer, last known follow-up (censored), or death without second primary (competing risk). Second primary rates are estimated by the cumulative incidence method.
Outcome measures
| Measure |
Neoadjuvant Chemoradiation With Irinotecan
n=52 Participants
Patients receive neoadjuvant therapy comprising radiotherapy, 1200mg/m2/day oral capecitabine and irinotecan. Surgery 4-8 weeks after RT. Postoperative chemotherapy (folinic acid, fluorouracil, and oxaliplatin) 4-6 weeks after surgery.
|
Neoadjuvant Chemoradiation With Oxaliplatin
n=52 Participants
Patients receive neoadjuvant therapy comprising radiotherapy, 1650mg/m2/day oral capecitabine and oxaliplatin. Surgery 4-8 weeks after RT. Postoperative chemotherapy (folinic acid, fluorouracil, and oxaliplatin) 4-6 weeks after surgery.
|
|---|---|---|
|
Second Primary Rate at 4 Years
|
2 percentage of participants
Interval 0.0 to 6.0
|
6 percentage of participants
Interval 0.0 to 13.0
|
SECONDARY outcome
Timeframe: From randomization to four yearsPopulation: Eligible patients enrolled after the protocol amendment
Disease-free survival time is defined as time from randomization to date of local-regional failure, the appearance of distant metastases, the appearance of a second primary failure, or date of death from any cause/ Disease-free survival rates are estimated by the Kaplan-Meier method. Patients last known to be alive without failure are censored at the date of last contact.
Outcome measures
| Measure |
Neoadjuvant Chemoradiation With Irinotecan
n=52 Participants
Patients receive neoadjuvant therapy comprising radiotherapy, 1200mg/m2/day oral capecitabine and irinotecan. Surgery 4-8 weeks after RT. Postoperative chemotherapy (folinic acid, fluorouracil, and oxaliplatin) 4-6 weeks after surgery.
|
Neoadjuvant Chemoradiation With Oxaliplatin
n=52 Participants
Patients receive neoadjuvant therapy comprising radiotherapy, 1650mg/m2/day oral capecitabine and oxaliplatin. Surgery 4-8 weeks after RT. Postoperative chemotherapy (folinic acid, fluorouracil, and oxaliplatin) 4-6 weeks after surgery.
|
|---|---|---|
|
Disease-free Survival Rate at 4 Years
|
68 percentage of participants
Interval 52.0 to 80.0
|
62 percentage of participants
Interval 47.0 to 74.0
|
SECONDARY outcome
Timeframe: From start of treatment to end of follow-up. Maximum follow-up is 5.2 years.Population: Eligible patients enrolled after the protocol amendment
Highest grade adverse event per subject were counted. Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.
Outcome measures
| Measure |
Neoadjuvant Chemoradiation With Irinotecan
n=52 Participants
Patients receive neoadjuvant therapy comprising radiotherapy, 1200mg/m2/day oral capecitabine and irinotecan. Surgery 4-8 weeks after RT. Postoperative chemotherapy (folinic acid, fluorouracil, and oxaliplatin) 4-6 weeks after surgery.
|
Neoadjuvant Chemoradiation With Oxaliplatin
n=52 Participants
Patients receive neoadjuvant therapy comprising radiotherapy, 1650mg/m2/day oral capecitabine and oxaliplatin. Surgery 4-8 weeks after RT. Postoperative chemotherapy (folinic acid, fluorouracil, and oxaliplatin) 4-6 weeks after surgery.
|
|---|---|---|
|
Number of Participants With Grade 3+ Treatment-related Adverse Events
Hematologic
|
20 Participants
|
19 Participants
|
|
Number of Participants With Grade 3+ Treatment-related Adverse Events
Non-Hematologic
|
32 Participants
|
29 Participants
|
|
Number of Participants With Grade 3+ Treatment-related Adverse Events
Overall
|
38 Participants
|
36 Participants
|
SECONDARY outcome
Timeframe: From start of treatment to surgery, approximately 10-16 weeks from randomization based on surgery occurring 4-8 weeks after chemoradiation. If no surgery, then <= 90 days from start of treatment.Population: Eligible patients enrolled after the protocol amendment
Highest grade adverse event per subject were counted. Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.
Outcome measures
| Measure |
Neoadjuvant Chemoradiation With Irinotecan
n=52 Participants
Patients receive neoadjuvant therapy comprising radiotherapy, 1200mg/m2/day oral capecitabine and irinotecan. Surgery 4-8 weeks after RT. Postoperative chemotherapy (folinic acid, fluorouracil, and oxaliplatin) 4-6 weeks after surgery.
|
Neoadjuvant Chemoradiation With Oxaliplatin
n=52 Participants
Patients receive neoadjuvant therapy comprising radiotherapy, 1650mg/m2/day oral capecitabine and oxaliplatin. Surgery 4-8 weeks after RT. Postoperative chemotherapy (folinic acid, fluorouracil, and oxaliplatin) 4-6 weeks after surgery.
|
|---|---|---|
|
Number of Participants With Grade 3+ Treatment-related Adverse Events Preoperatively
Hematologic
|
5 Participants
|
2 Participants
|
|
Number of Participants With Grade 3+ Treatment-related Adverse Events Preoperatively
Non-Hematologic
|
11 Participants
|
14 Participants
|
|
Number of Participants With Grade 3+ Treatment-related Adverse Events Preoperatively
Overall
|
14 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: From post-surgery to before chemotherapy (CT), or within 60 days of surgery if no postoperative CT. Approximately 10-16 weeks to 14-22 weeks from randomization based on CT starting 4-6 weeks after surgery.Population: Eligible patients enrolled after the protocol amendment who had surgery
Highest grade adverse event per subject were counted. Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.
Outcome measures
| Measure |
Neoadjuvant Chemoradiation With Irinotecan
n=47 Participants
Patients receive neoadjuvant therapy comprising radiotherapy, 1200mg/m2/day oral capecitabine and irinotecan. Surgery 4-8 weeks after RT. Postoperative chemotherapy (folinic acid, fluorouracil, and oxaliplatin) 4-6 weeks after surgery.
|
Neoadjuvant Chemoradiation With Oxaliplatin
n=51 Participants
Patients receive neoadjuvant therapy comprising radiotherapy, 1650mg/m2/day oral capecitabine and oxaliplatin. Surgery 4-8 weeks after RT. Postoperative chemotherapy (folinic acid, fluorouracil, and oxaliplatin) 4-6 weeks after surgery.
|
|---|---|---|
|
Number of Participants With Grade 3+ Treatment-related Adverse Events Postoperatively
Hematologic
|
1 Participants
|
3 Participants
|
|
Number of Participants With Grade 3+ Treatment-related Adverse Events Postoperatively
Non-Hematologic
|
9 Participants
|
9 Participants
|
|
Number of Participants With Grade 3+ Treatment-related Adverse Events Postoperatively
Overall
|
9 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: End of studyPopulation: The data required for this analysis was not obtained and will not be obtained.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and completion of chemoradiation, approximately 6-8 weeks from randomizationPopulation: Eligible patients enrolled after the protocol amendment who have QLQ-C30 Global Health Status score at baseline and completion of chemoradiation
Global Health Status is calculated from two questions on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire \[EORTC QLQ\]-C30. The question responses range from 1 "very poor" to 7 "excellent" such that a higher response indicates better quality of life (QOL). The mean of these responses is linearly transformed to a range of 0 (worst) to 100 (best). Change from baseline is calculated as the time point value - baseline value and a decrease from baseline indicates decline in quality of life. A positive number indicates improvement in QOL.
Outcome measures
| Measure |
Neoadjuvant Chemoradiation With Irinotecan
n=34 Participants
Patients receive neoadjuvant therapy comprising radiotherapy, 1200mg/m2/day oral capecitabine and irinotecan. Surgery 4-8 weeks after RT. Postoperative chemotherapy (folinic acid, fluorouracil, and oxaliplatin) 4-6 weeks after surgery.
|
Neoadjuvant Chemoradiation With Oxaliplatin
n=32 Participants
Patients receive neoadjuvant therapy comprising radiotherapy, 1650mg/m2/day oral capecitabine and oxaliplatin. Surgery 4-8 weeks after RT. Postoperative chemotherapy (folinic acid, fluorouracil, and oxaliplatin) 4-6 weeks after surgery.
|
|---|---|---|
|
Change From Baseline in QLQ-C30 Global Health Status Score at Completion of Chemoradiation
|
-10.3 score on a scale
Standard Deviation 23.7
|
-12.2 score on a scale
Standard Deviation 23.5
|
SECONDARY outcome
Timeframe: Baseline and completion of post-operative chemotherapy approximately 32 to 40 weeks from randomization based on 18 weeks of post-operative chemotherapyPopulation: Eligible patients enrolled after the protocol amendment who have QLQ-C30 Global Health Status score at baseline and completion of post-operative chemotherapy
Global Health Status is calculated from two questions on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire \[EORTC QLQ\]-C30. The question responses range from 1 "very poor" to 7 "excellent" such that a higher response indicates better quality of life (QOL). The mean of these responses is linearly transformed to a range of 0 (worst) to 100 (best). Change from baseline is calculated as the time point value - baseline value and a decrease from baseline indicates decline in quality of life. A positive number indicates improvement in QOL.
Outcome measures
| Measure |
Neoadjuvant Chemoradiation With Irinotecan
n=20 Participants
Patients receive neoadjuvant therapy comprising radiotherapy, 1200mg/m2/day oral capecitabine and irinotecan. Surgery 4-8 weeks after RT. Postoperative chemotherapy (folinic acid, fluorouracil, and oxaliplatin) 4-6 weeks after surgery.
|
Neoadjuvant Chemoradiation With Oxaliplatin
n=28 Participants
Patients receive neoadjuvant therapy comprising radiotherapy, 1650mg/m2/day oral capecitabine and oxaliplatin. Surgery 4-8 weeks after RT. Postoperative chemotherapy (folinic acid, fluorouracil, and oxaliplatin) 4-6 weeks after surgery.
|
|---|---|---|
|
Change From Baseline in QLQ-C30 Global Health Status Score at Completion of Post-operative Chemotherapy
|
-12.5 score on a scale
Standard Deviation 26.7
|
-7.1 score on a scale
Standard Deviation 15.0
|
SECONDARY outcome
Timeframe: Baseline and two yearsPopulation: Eligible patients enrolled after the protocol amendment who have QLQ-C30 Global Health Status score at baseline and two years
Global Health Status is calculated from two questions on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire \[EORTC QLQ\]-C30. The question responses range from 1 "very poor" to 7 "excellent" such that a higher response indicates better quality of life (QOL). The mean of these responses is linearly transformed to a range of 0 (worst) to 100 (best). Change from baseline is calculated as the time point value - baseline value and a decrease from baseline indicates decline in quality of life. A negative number indicates improvement in symptoms.
Outcome measures
| Measure |
Neoadjuvant Chemoradiation With Irinotecan
n=21 Participants
Patients receive neoadjuvant therapy comprising radiotherapy, 1200mg/m2/day oral capecitabine and irinotecan. Surgery 4-8 weeks after RT. Postoperative chemotherapy (folinic acid, fluorouracil, and oxaliplatin) 4-6 weeks after surgery.
|
Neoadjuvant Chemoradiation With Oxaliplatin
n=20 Participants
Patients receive neoadjuvant therapy comprising radiotherapy, 1650mg/m2/day oral capecitabine and oxaliplatin. Surgery 4-8 weeks after RT. Postoperative chemotherapy (folinic acid, fluorouracil, and oxaliplatin) 4-6 weeks after surgery.
|
|---|---|---|
|
Change From Baseline in QLQ-C30 Global Health Status Score at Two Years
|
-6.8 score on a scale
Standard Deviation 28.3
|
-1.3 score on a scale
Standard Deviation 14.4
|
SECONDARY outcome
Timeframe: Baseline and completion of chemoradiation approximately 6-8 weeks from randomizationPopulation: Eligible patients enrolled after the protocol amendment who have QLQ-C38 GI score at baseline and completion of chemoradiation
The gastro-intestinal (GI) symptom score is calculated from five symptom questions on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire \[EORTC QLQ\]-CR38. The question responses range from 1 (not at all) to 4 (very much) such that a higher response indicates worse symptoms. The mean of these responses is linearly transformed to a range of 0 (best) to 100 (worst). Change from baseline is calculated as the time point value - baseline value and a decrease from baseline indicates improvement in symptoms. A negative number indicates improvement in symptoms.
Outcome measures
| Measure |
Neoadjuvant Chemoradiation With Irinotecan
n=34 Participants
Patients receive neoadjuvant therapy comprising radiotherapy, 1200mg/m2/day oral capecitabine and irinotecan. Surgery 4-8 weeks after RT. Postoperative chemotherapy (folinic acid, fluorouracil, and oxaliplatin) 4-6 weeks after surgery.
|
Neoadjuvant Chemoradiation With Oxaliplatin
n=33 Participants
Patients receive neoadjuvant therapy comprising radiotherapy, 1650mg/m2/day oral capecitabine and oxaliplatin. Surgery 4-8 weeks after RT. Postoperative chemotherapy (folinic acid, fluorouracil, and oxaliplatin) 4-6 weeks after surgery.
|
|---|---|---|
|
Change From Baseline in EORTC QLQ-CR38 Gastro-intestinal Symptom Score at Completion of Chemoradiation
|
5.9 score on a scale
Standard Deviation 22.3
|
20.3 score on a scale
Standard Deviation 22.1
|
SECONDARY outcome
Timeframe: Baseline and completion of post-operative chemotherapy approximately 32 to 40 weeks from randomization based on 18 weeks of post-operative chemotherapyPopulation: Eligible patients enrolled after the protocol amendment who have QLQ-C38 GI score at baseline and completion of post-operative chemotherapy
The gastro-intestinal (GI) symptom score is calculated from five symptom questions on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire \[EORTC QLQ\]-CR38. The question responses range from 1 (not at all) to 4 (very much) such that a higher response indicates worse symptoms. The mean of these responses is linearly transformed to a range of 0 (best) to 100 (worst). Change from baseline is calculated as the time point value - baseline value and a decrease from baseline indicates improvement in symptoms. A negative number indicates improvement in symptoms.
Outcome measures
| Measure |
Neoadjuvant Chemoradiation With Irinotecan
n=22 Participants
Patients receive neoadjuvant therapy comprising radiotherapy, 1200mg/m2/day oral capecitabine and irinotecan. Surgery 4-8 weeks after RT. Postoperative chemotherapy (folinic acid, fluorouracil, and oxaliplatin) 4-6 weeks after surgery.
|
Neoadjuvant Chemoradiation With Oxaliplatin
n=27 Participants
Patients receive neoadjuvant therapy comprising radiotherapy, 1650mg/m2/day oral capecitabine and oxaliplatin. Surgery 4-8 weeks after RT. Postoperative chemotherapy (folinic acid, fluorouracil, and oxaliplatin) 4-6 weeks after surgery.
|
|---|---|---|
|
Change From Baseline in EORTC QLQ-CR38 Gastro-intestinal Symptom Score at Completion of Post-operative Chemotherapy
|
-1.5 score on a scale
Standard Deviation 12.7
|
3.9 score on a scale
Standard Deviation 15.4
|
SECONDARY outcome
Timeframe: Baseline and two yearsPopulation: Eligible patients enrolled after the protocol amendment who have QLQ-C38 GI score at baseline and completion of post-operative chemotherapy
The gastro-intestinal (GI) symptom score is calculated from five symptom questions on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire \[EORTC QLQ\]-CR38. The question responses range from 1 (not at all) to 4 (very much) such that a higher response indicates worse symptoms. The mean of these responses is linearly transformed to a range of 0 (best) to 100 (worst). Change from baseline is calculated as the time point value - baseline value and a decrease from baseline indicates improvement in symptoms. A negative number indicates improvement in symptoms.
Outcome measures
| Measure |
Neoadjuvant Chemoradiation With Irinotecan
n=21 Participants
Patients receive neoadjuvant therapy comprising radiotherapy, 1200mg/m2/day oral capecitabine and irinotecan. Surgery 4-8 weeks after RT. Postoperative chemotherapy (folinic acid, fluorouracil, and oxaliplatin) 4-6 weeks after surgery.
|
Neoadjuvant Chemoradiation With Oxaliplatin
n=20 Participants
Patients receive neoadjuvant therapy comprising radiotherapy, 1650mg/m2/day oral capecitabine and oxaliplatin. Surgery 4-8 weeks after RT. Postoperative chemotherapy (folinic acid, fluorouracil, and oxaliplatin) 4-6 weeks after surgery.
|
|---|---|---|
|
Change From Baseline in EORTC QLQ-CR38 Gastro-intestinal Symptom Score at Two Years
|
0.4 score on a scale
Standard Deviation 20.3
|
6.7 score on a scale
Standard Deviation 12.7
|
SECONDARY outcome
Timeframe: Baseline and completion of chemoradiation, approximately 6-8 weeks from randomizationPopulation: Eligible patients enrolled after the protocol amendment who have QLQ-C38 defecation score at baseline and completion of chemoradiation
The defecation symptom score is calculated from seven symptom questions on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire \[EORTC QLQ\]-CR38. The question responses range from 1 "not at all" to 4 "very much" such that a higher response indicates worse symptoms. The mean of these responses is linearly transformed to a range of 0 (best) to 100 (worst). Change from baseline is calculated as the time point value - baseline value and a decrease from baseline indicates improvement in symptoms. A negative number indicates improvement in symptoms.
Outcome measures
| Measure |
Neoadjuvant Chemoradiation With Irinotecan
n=32 Participants
Patients receive neoadjuvant therapy comprising radiotherapy, 1200mg/m2/day oral capecitabine and irinotecan. Surgery 4-8 weeks after RT. Postoperative chemotherapy (folinic acid, fluorouracil, and oxaliplatin) 4-6 weeks after surgery.
|
Neoadjuvant Chemoradiation With Oxaliplatin
n=32 Participants
Patients receive neoadjuvant therapy comprising radiotherapy, 1650mg/m2/day oral capecitabine and oxaliplatin. Surgery 4-8 weeks after RT. Postoperative chemotherapy (folinic acid, fluorouracil, and oxaliplatin) 4-6 weeks after surgery.
|
|---|---|---|
|
Change From Baseline in EORTC QLQ-CR38 Defecation Symptom Score at Completion of Chemoradiation
|
4.8 score on a scale
Standard Deviation 21.6
|
8.8 score on a scale
Standard Deviation 21.8
|
SECONDARY outcome
Timeframe: Baseline and completion of post-operative chemotherapy, approximately 32 to 40 weeks from randomization based on 18 weeks of post-operative chemotherapyPopulation: Eligible patients enrolled after the protocol amendment who have QLQ-C38 defecation score at baseline and completion of chemoradiation
The defecation symptom score is calculated from seven symptom questions on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire \[EORTC QLQ\]-CR38. The question responses range from 1 "not at all" to 4 "very much" such that a higher response indicates worse symptoms. The mean of these responses is linearly transformed to a range of 0 (best) to 100 (worst). Change from baseline is calculated as the time point value - baseline value and a decrease from baseline indicates improvement in symptoms. A negative number indicates improvement in symptoms.
Outcome measures
| Measure |
Neoadjuvant Chemoradiation With Irinotecan
n=12 Participants
Patients receive neoadjuvant therapy comprising radiotherapy, 1200mg/m2/day oral capecitabine and irinotecan. Surgery 4-8 weeks after RT. Postoperative chemotherapy (folinic acid, fluorouracil, and oxaliplatin) 4-6 weeks after surgery.
|
Neoadjuvant Chemoradiation With Oxaliplatin
n=14 Participants
Patients receive neoadjuvant therapy comprising radiotherapy, 1650mg/m2/day oral capecitabine and oxaliplatin. Surgery 4-8 weeks after RT. Postoperative chemotherapy (folinic acid, fluorouracil, and oxaliplatin) 4-6 weeks after surgery.
|
|---|---|---|
|
Change From Baseline in EORTC QLQ-CR38 Defecation Symptom Score at Post-operative Chemotherapy
|
-1.6 score on a scale
Standard Deviation 16.2
|
14.6 score on a scale
Standard Deviation 16.6
|
SECONDARY outcome
Timeframe: Baseline and two yearsPopulation: Eligible patients enrolled after the protocol amendment who have QLQ-C38 defecation score at baseline and two years
The defecation symptom score is calculated from seven symptom questions on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire \[EORTC QLQ\]-CR38. The question responses range from 1 "not at all" to 4 "very much" such that a higher response indicates worse symptoms. The mean of these responses is linearly transformed to a range of 0 (best) to 100 (worst). Change from baseline is calculated as the time point value - baseline value and a decrease from baseline indicates improvement in symptoms. A negative number indicates improvement in symptoms.
Outcome measures
| Measure |
Neoadjuvant Chemoradiation With Irinotecan
n=13 Participants
Patients receive neoadjuvant therapy comprising radiotherapy, 1200mg/m2/day oral capecitabine and irinotecan. Surgery 4-8 weeks after RT. Postoperative chemotherapy (folinic acid, fluorouracil, and oxaliplatin) 4-6 weeks after surgery.
|
Neoadjuvant Chemoradiation With Oxaliplatin
n=15 Participants
Patients receive neoadjuvant therapy comprising radiotherapy, 1650mg/m2/day oral capecitabine and oxaliplatin. Surgery 4-8 weeks after RT. Postoperative chemotherapy (folinic acid, fluorouracil, and oxaliplatin) 4-6 weeks after surgery.
|
|---|---|---|
|
Change From Baseline in EORTC QLQ-CR38 Defecation Symptom Score at Two Years
|
0.4 score on a scale
Standard Deviation 20.5
|
-1.6 score on a scale
Standard Deviation 12.9
|
Adverse Events
Neoadjuvant Chemoradiation With Irinotecan
Serious events: 37 serious events
Other events: 70 other events
Deaths: 0 deaths
Neoadjuvant Chemoradiation With Oxaliplatin
Serious events: 36 serious events
Other events: 67 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Neoadjuvant Chemoradiation With Irinotecan
n=70 participants at risk
Patients receive neoadjuvant therapy comprising radiotherapy, 1200mg/m2/day oral capecitabine and irinotecan. Surgery 4-8 weeks after RT. Postoperative chemotherapy (folinic acid, fluorouracil, and oxaliplatin) 4-6 weeks after surgery.
|
Neoadjuvant Chemoradiation With Oxaliplatin
n=68 participants at risk
Patients receive neoadjuvant therapy comprising radiotherapy, 1650mg/m2/day oral capecitabine and oxaliplatin. Surgery 4-8 weeks after RT. Postoperative chemotherapy (folinic acid, fluorouracil, and oxaliplatin) 4-6 weeks after surgery.
|
|---|---|---|
|
Psychiatric disorders
Confusional state
|
1.4%
1/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Psychiatric disorders
Insomnia
|
1.4%
1/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Renal and urinary disorders
Renal failure NOS
|
0.00%
0/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
2.9%
2/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Renal and urinary disorders
Renal/genitourinary - Other:
|
0.00%
0/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.5%
1/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.00%
0/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.5%
1/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Renal and urinary disorders
Vesical fistula
|
0.00%
0/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
2.9%
2/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Reproductive system and breast disorders
Menstruation irregular
|
0.00%
0/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.5%
1/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Reproductive system and breast disorders
Pelvic pain NOS
|
0.00%
0/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.5%
1/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Reproductive system and breast disorders
Testicular pain
|
0.00%
0/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.5%
1/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Reproductive system and breast disorders
Vulvovaginal dryness
|
1.4%
1/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.9%
2/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.5%
1/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis NOS
|
0.00%
0/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.5%
1/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Skin and subcutaneous tissue disorders
Acne NOS
|
0.00%
0/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.5%
1/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.5%
1/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Skin and subcutaneous tissue disorders
Dermatitis exfoliative NOS
|
2.9%
2/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.5%
1/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Skin and subcutaneous tissue disorders
Sweating increased
|
1.4%
1/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Vascular disorders
Hypotension NOS
|
2.9%
2/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
2.9%
2/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Vascular disorders
Thrombosis
|
2.9%
2/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
8.8%
6/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Blood and lymphatic system disorders
Blood/bone marrow - Other:
|
1.4%
1/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.5%
1/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
10.0%
7/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
10.3%
7/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Cardiac disorders
Angina pectoris
|
1.4%
1/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Cardiac disorders
Atrial fibrillation
|
1.4%
1/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Cardiac disorders
Diastolic dysfunction
|
1.4%
1/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.5%
1/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Cardiac disorders
Supraventricular arrhythmia NOS
|
0.00%
0/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.5%
1/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Abdominal distention
|
0.00%
0/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.5%
1/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Abdominal pain NOS
|
4.3%
3/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
4.4%
3/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Colitis NOS
|
0.00%
0/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
2.9%
2/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Colonic obstruction
|
1.4%
1/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Constipation
|
1.4%
1/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.5%
1/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Diarrhoea NOS
|
18.6%
13/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
23.5%
16/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.5%
1/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
1.4%
1/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Dyspepsia
|
1.4%
1/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Enteritis
|
1.4%
1/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.5%
1/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Faecal incontinence
|
0.00%
0/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.5%
1/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Gastrointestinal - Other:
|
0.00%
0/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.5%
1/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.5%
1/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Ileus paralytic
|
1.4%
1/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.5%
1/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Intestinal fistula
|
0.00%
0/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.5%
1/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Nausea
|
5.7%
4/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
7.4%
5/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Proctalgia
|
2.9%
2/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
4.4%
3/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Proctitis NOS
|
0.00%
0/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
4.4%
3/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Rectal fistula
|
1.4%
1/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
2.9%
2/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Rectal stenosis
|
0.00%
0/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.5%
1/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Rectal ulcer
|
0.00%
0/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.5%
1/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Small intestinal stricture NOS
|
4.3%
3/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.9%
4/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Tooth development disorder
|
0.00%
0/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.5%
1/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Vomiting NOS
|
4.3%
3/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
8.8%
6/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Chest pain
|
1.4%
1/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Death NOS
|
0.00%
0/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.5%
1/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Fatigue
|
5.7%
4/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
8.8%
6/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Multi-organ failure
|
1.4%
1/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Pain - Other:
|
1.4%
1/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Pyrexia
|
2.9%
2/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
4.4%
3/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Rigors
|
1.4%
1/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.5%
1/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Sudden death
|
0.00%
0/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.5%
1/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Abdominal infection
|
1.4%
1/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.5%
1/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Ano-rectal infection NOS
|
0.00%
0/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.5%
1/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Infection - Other:
|
0.00%
0/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.5%
1/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Blood
|
1.4%
1/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Lung (pneumonia)
|
0.00%
0/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.5%
1/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Skin (cellulitis)
|
1.4%
1/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Urinary tract NOS
|
0.00%
0/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.5%
1/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Wound
|
1.4%
1/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils: Blood
|
0.00%
0/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.5%
1/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils: Pelvis NOS
|
0.00%
0/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.5%
1/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils: Wound
|
1.4%
1/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Infection with unknown ANC: Bladder (urinary)
|
0.00%
0/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.5%
1/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Peritoneal infection
|
0.00%
0/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
2.9%
2/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Wound infection
|
0.00%
0/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.5%
1/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Injury, poisoning and procedural complications
Culture wound negative
|
0.00%
0/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.5%
1/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Injury, poisoning and procedural complications
Dermatitis radiation NOS
|
0.00%
0/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
4.4%
3/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Injury, poisoning and procedural complications
Leak (including anastomotic), GI: Small bowel
|
0.00%
0/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.5%
1/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Injury, poisoning and procedural complications
Radiation recall syndrome
|
0.00%
0/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.5%
1/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Blood alkaline phosphatase increased
|
1.4%
1/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Blood creatinine increased
|
1.4%
1/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
4.4%
3/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Coagulopathy
|
0.00%
0/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.5%
1/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Leukopenia NOS
|
11.4%
8/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
7.4%
5/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Lymphopenia
|
0.00%
0/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.5%
1/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Metabolic/laboratory - Other:
|
0.00%
0/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.5%
1/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Neutrophil count
|
4.3%
3/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.5%
1/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Platelet count decreased
|
2.9%
2/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
4.4%
3/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Weight decreased
|
1.4%
1/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
4.4%
3/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Alkalosis NOS
|
0.00%
0/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.5%
1/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Dehydration
|
15.7%
11/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
10.3%
7/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hyperglycaemia NOS
|
1.4%
1/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.9%
4/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.5%
1/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
1.4%
1/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.5%
1/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
1.4%
1/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
4.4%
3/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
2.9%
2/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
2.9%
2/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
2.9%
2/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.9%
4/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.5%
1/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
2.9%
2/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Musculoskeletal and connective tissue disorders
Arthritis NOS
|
0.00%
0/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.5%
1/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness NOS
|
1.4%
1/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/soft tissue - Other:
|
0.00%
0/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.5%
1/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.4%
1/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.5%
1/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Dizziness
|
1.4%
1/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.5%
1/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.5%
1/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
4.3%
3/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
4.4%
3/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Syncope vasovagal
|
0.00%
0/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.5%
1/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Tremor
|
1.4%
1/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
Other adverse events
| Measure |
Neoadjuvant Chemoradiation With Irinotecan
n=70 participants at risk
Patients receive neoadjuvant therapy comprising radiotherapy, 1200mg/m2/day oral capecitabine and irinotecan. Surgery 4-8 weeks after RT. Postoperative chemotherapy (folinic acid, fluorouracil, and oxaliplatin) 4-6 weeks after surgery.
|
Neoadjuvant Chemoradiation With Oxaliplatin
n=68 participants at risk
Patients receive neoadjuvant therapy comprising radiotherapy, 1650mg/m2/day oral capecitabine and oxaliplatin. Surgery 4-8 weeks after RT. Postoperative chemotherapy (folinic acid, fluorouracil, and oxaliplatin) 4-6 weeks after surgery.
|
|---|---|---|
|
Blood and lymphatic system disorders
Blood/bone marrow - Other:
|
1.4%
1/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
7.4%
5/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
71.4%
50/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
64.7%
44/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Abdominal pain NOS
|
30.0%
21/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
25.0%
17/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Constipation
|
35.7%
25/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
29.4%
20/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Diarrhoea NOS
|
80.0%
56/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
83.8%
57/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Dyspepsia
|
11.4%
8/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
4.4%
3/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Faecal incontinence
|
5.7%
4/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
8.8%
6/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Flatulence
|
11.4%
8/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.9%
4/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Gastrointestinal - Other:
|
4.3%
3/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
10.3%
7/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Hemorrhoids
|
8.6%
6/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
4.4%
3/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Nausea
|
55.7%
39/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
66.2%
45/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Proctalgia
|
25.7%
18/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
32.4%
22/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Proctitis NOS
|
17.1%
12/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
17.6%
12/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Radiation mucositis
|
4.3%
3/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.9%
4/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
17.1%
12/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
8.8%
6/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Stomatitis
|
12.9%
9/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
10.3%
7/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Vomiting NOS
|
27.1%
19/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
29.4%
20/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Constitutional Symptoms - Other:
|
5.7%
4/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.5%
1/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Edema: limb:
|
4.3%
3/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
10.3%
7/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Fatigue
|
68.6%
48/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
75.0%
51/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Pain - Other:
|
7.1%
5/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
7.4%
5/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Pyrexia
|
5.7%
4/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
8.8%
6/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Injury, poisoning and procedural complications
Dermatitis radiation NOS
|
24.3%
17/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
20.6%
14/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Injury, poisoning and procedural complications
Radiation recall syndrome
|
5.7%
4/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
11.8%
8/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Alanine aminotransferase increased
|
25.7%
18/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
39.7%
27/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Aspartate aminotransferase increased
|
24.3%
17/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
36.8%
25/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Blood alkaline phosphatase increased
|
15.7%
11/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
30.9%
21/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Blood bilirubin increased
|
8.6%
6/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.9%
4/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Blood creatinine increased
|
12.9%
9/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
11.8%
8/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Leukopenia NOS
|
68.6%
48/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
60.3%
41/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Lymphopenia
|
8.6%
6/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
8.8%
6/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Metabolic/laboratory - Other:
|
10.0%
7/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
19.1%
13/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Neutrophil count
|
47.1%
33/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
45.6%
31/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Platelet count decreased
|
40.0%
28/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
42.6%
29/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Weight decreased
|
22.9%
16/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
27.9%
19/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Anorexia
|
32.9%
23/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
30.9%
21/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Dehydration
|
11.4%
8/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
25.0%
17/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hyperglycaemia NOS
|
52.9%
37/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
36.8%
25/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
5.7%
4/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
8.8%
6/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
22.9%
16/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
33.8%
23/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
21.4%
15/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
32.4%
22/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hypoglycemia NOS
|
5.7%
4/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
2.9%
2/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
25.7%
18/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
35.3%
24/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
10.0%
7/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
10.3%
7/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
25.7%
18/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
36.8%
25/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
5.7%
4/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
2.9%
2/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.6%
6/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.5%
1/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.6%
6/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
4.4%
3/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.1%
5/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
7.4%
5/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.9%
4/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Dizziness
|
11.4%
8/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.5%
1/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Dysgeusia
|
7.1%
5/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
14.7%
10/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Headache
|
2.9%
2/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.9%
4/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Neuralgia NOS
|
0.00%
0/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.9%
4/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
51.4%
36/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
64.7%
44/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Psychiatric disorders
Anxiety
|
5.7%
4/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
7.4%
5/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Psychiatric disorders
Depression
|
10.0%
7/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
10.3%
7/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Psychiatric disorders
Insomnia
|
7.1%
5/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
13.2%
9/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Renal and urinary disorders
Bladder pain
|
8.6%
6/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.9%
4/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Renal and urinary disorders
Pollakiuria
|
20.0%
14/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
16.2%
11/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Renal and urinary disorders
Renal/genitourinary - Other:
|
7.1%
5/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
7.4%
5/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Renal and urinary disorders
Urinary incontinence
|
7.1%
5/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
4.4%
3/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Renal and urinary disorders
Urinary retention
|
8.6%
6/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.9%
4/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Reproductive system and breast disorders
Erectile dysfunction NOS
|
4.3%
3/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.9%
4/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.7%
4/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.9%
4/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.0%
7/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
10.3%
7/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
12.9%
9/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
4.4%
3/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Skin and subcutaneous tissue disorders
Dermatitis exfoliative NOS
|
8.6%
6/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
13.2%
9/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.7%
4/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
8.8%
6/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Skin and subcutaneous tissue disorders
Localised exfoliation
|
4.3%
3/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
10.3%
7/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.9%
2/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.9%
4/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Vascular disorders
Hypertension NOS
|
2.9%
2/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.9%
4/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Vascular disorders
Hypotension NOS
|
7.1%
5/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
2.9%
2/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Vascular disorders
Thrombosis
|
1.4%
1/70
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
7.4%
5/68
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place