Trial · NCT00303628
Postoperative Chemotherapy With or Without Bevacizumab for Patients With Stage II or III Rectal Cancer
NCT00303628, Phase 3, Terminated, ECOG-ACRIN Cancer Research Group; results first posted 2016-02-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Postoperative Chemotherapy With or Without Bevacizumab for Patients With Stage II or III Rectal Cancer. Trials, record NCT00303628. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00303628
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Postoperative Chemotherapy With or Without Bevacizumab for Patients With Stage II or III Rectal Cancer
- NCT number
- NCT00303628
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 355 participants, actual
- Lead sponsor
- ECOG-ACRIN Cancer Research Group
- Conditions
- Adenocarcinoma of the Rectum, Stage II Rectal Cancer, Stage III Rectal Cancer
- Interventions
- oxaliplatin, fluorouracil, leucovorin calcium, bevacizumab
- First posted
- 2006-03-17
- Last updated
- 2023-07-06
- Results first posted
- 2016-02-26
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 5-year Overall Survival Rate | Follow-up assessments performed every 3 months for patients < 2 years from randomization, every 6 months for patients 2-5 years from randomization, and every 12 months for patients 5-10 years from randomization | Overall survival (OS) was defined as time from randomization to date of death from any cause. Patients who were still alive were censored at last date of known alive. Kaplan-Meier method was used to estimate the 5-year OS rate. |
| Secondary | 5-year Disease-free Survival Rate | Follow-up assessments performed every 3 months for patients < 2 years from randomization, every 6 months for patients 2-5 years from randomization, and every 12 months for patients 5-10 years from randomization | Disease-free survival (DFS) was defined as time from randomization to recurrence, second invasive primary cancer or death, whichever occurred first. Patients who were still alive and had no DFS events were censored at the last disease assessment date known to be free of DFS events. Kaplan-Meier method was used to estimate 5-year DFS rate. |
| Secondary | Patterns of Failure | Follow-up assessments performed every 3 months for patients < 2 years from randomization, every 6 months for patients 2-5 years from randomization, and every 12 months for patients 5-10 years from randomization | Failure included recurrence, second primary cancer and death without recurrence. |
| Secondary | Proportion of Patients Who Completed 12 Cycles of Treatment | assessed at the end of treatment | In the study, treatment was repeated every 2 weeks for a total of 12 cycles on both arms. The total number of cycles of treatment patient received until going off treatment due to any reason was recorded. It was a measure of the tolerance of the therapy. |
| Other | Change in Rectal Function Between Baseline and 12 Months | assessed at baseline and 12 months after randomization | Change in rectal function between baseline and 12 months was measuring the long-term rectal function among the patients. Rectal function was measured using the Bowel Function Questionnaire at baseline and 12 months after randomization. The total score of the questionnaire was calculated as the number of problems with bowel function (score range 0-11). Change in rectal function between baseline and 12 months= total score at 12 months - total score at baseline. A negative value indicated improved rectal function. This change in score was calculated for each individual patient who had the data. |
| Other | Change in Oxaliplatin-related Neurotoxicity Between Baseline and 12 Months | assessed at baseline and 12 months after randomization | Change in oxaliplatin-related neurotoxicity between baseline and 12 months was measuring the long-term symptom of oxaliplatin-related neurotoxicity among the patients. Oxaliplatin-related neurotoxicity was measured using the FACT/GOG-Ntx subscale at baseline and 12 months after randomization. The range of the total score of the scale was between 0 and 44, and lower values indicate higher neurotoxicity. Change in oxaliplatin-related neurotoxicity between baseline and 12 months= total score at 12 months - total score at baseline. A negative value indicated worsened symptom. This change in score was calculated for each individual patient who had the data. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 5-year Overall Survival Rate | Follow-up assessments performed every 3 months for patients < 2 years from randomization, every 6 months for patients 2-5 years from randomization, and every 12 months for patients 5-10 years from randomization | All randomized patients (intent-to-treat population) | proportion of participants | NUMBER |
| SECONDARY | 5-year Disease-free Survival Rate | Follow-up assessments performed every 3 months for patients < 2 years from randomization, every 6 months for patients 2-5 years from randomization, and every 12 months for patients 5-10 years from randomization | All randomized patients (intent-to-treat population) | proportion of participants | NUMBER |
| SECONDARY | Patterns of Failure | Follow-up assessments performed every 3 months for patients < 2 years from randomization, every 6 months for patients 2-5 years from randomization, and every 12 months for patients 5-10 years from randomization | all randomized patients | participants | NUMBER |
| SECONDARY | Proportion of Patients Who Completed 12 Cycles of Treatment | assessed at the end of treatment | Patients who received at least one cycle of protocol treatment | proportion of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Change in Rectal Function Between Baseline and 12 Months | assessed at baseline and 12 months after randomization | Patients with data about their rectal function measured using the Bowel Function Questionnaire at both baseline and 12 months after randomization. Due to the early termination of the trial, the sample size was quite small for the endpoint. Consequently, it was considered as an exploratory endpoint. | scores on a scale | MEAN |
| OTHER_PRE_SPECIFIED | Change in Oxaliplatin-related Neurotoxicity Between Baseline and 12 Months | assessed at baseline and 12 months after randomization | Patients with data about their oxaliplatin-related neurotoxicity measured using FACT/GOG Ntx subscale at both baseline and 12 months after randomization. Due to the early termination of the trial, the sample size was quite small for the endpoint. Consequently, it was considered as an exploratory endpoint. | scores on a scale | MEAN |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 5-year Overall Survival Rate | Arm I (Oxaliplatin, Fluorouracil, Leucovorin) | 0.883 | 95% Confidence Interval 0.523 to 0.924 | proportion of participants | |
| 5-year Overall Survival Rate | Arm II (Oxaliplatin, Fluorouracil, Leucovorin, Bevacizumab) | 0.837 | 95% Confidence Interval 0.771 to 0.886 | proportion of participants | |
| 5-year Disease-free Survival Rate | Arm I (Oxaliplatin, Fluorouracil, Leucovorin) | 0.712 | 95% Confidence Interval 0.634 to 0.776 | proportion of participants | |
| 5-year Disease-free Survival Rate | Arm II (Oxaliplatin, Fluorouracil, Leucovorin, Bevacizumab) | 0.765 | 95% Confidence Interval 0.692 to 0.823 | proportion of participants | |
| Patterns of Failure | Arm I (Oxaliplatin, Fluorouracil, Leucovorin) | Local/regional recurrence | 6 | participants | |
| Patterns of Failure | Arm II (Oxaliplatin, Fluorouracil, Leucovorin, Bevacizumab) | Local/regional recurrence | 5 | participants | |
| Patterns of Failure | Arm I (Oxaliplatin, Fluorouracil, Leucovorin) | Distant recurrence | 24 | participants | |
| Patterns of Failure | Arm II (Oxaliplatin, Fluorouracil, Leucovorin, Bevacizumab) | Distant recurrence | 20 | participants | |
| Patterns of Failure | Arm I (Oxaliplatin, Fluorouracil, Leucovorin) | Mutiple recurrence | 5 | participants | |
| Patterns of Failure | Arm II (Oxaliplatin, Fluorouracil, Leucovorin, Bevacizumab) | Mutiple recurrence | 8 | participants |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm I (Oxaliplatin, Fluorouracil, Leucovorin) | 176 | |
| Overall Study | STARTED | Arm II (Oxaliplatin, Fluorouracil, Leucovorin, Bevacizumab) | 179 | |
| Overall Study | Eligible | Arm I (Oxaliplatin, Fluorouracil, Leucovorin) | 171 | |
| Overall Study | Eligible | Arm II (Oxaliplatin, Fluorouracil, Leucovorin, Bevacizumab) | 177 | |
| Overall Study | Treated | Arm I (Oxaliplatin, Fluorouracil, Leucovorin) | 173 | |
| Overall Study | Treated | Arm II (Oxaliplatin, Fluorouracil, Leucovorin, Bevacizumab) | 174 | |
| Overall Study | COMPLETED | Arm I (Oxaliplatin, Fluorouracil, Leucovorin) | 126 | |
| Overall Study | COMPLETED | Arm II (Oxaliplatin, Fluorouracil, Leucovorin, Bevacizumab) | 106 | |
| Overall Study | NOT COMPLETED | Arm I (Oxaliplatin, Fluorouracil, Leucovorin) | 50 | |
| Overall Study | NOT COMPLETED | Arm II (Oxaliplatin, Fluorouracil, Leucovorin, Bevacizumab) | 73 |
Source ClinicalTrials.gov
Adverse events282
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Allergic reaction | Immune system disorders | Arm I (Oxaliplatin, Fluorouracil, Leucovorin) | 9 | 173 | |
| other | Allergic reaction | Immune system disorders | Arm II (Oxaliplatin, Fluorouracil, Leucovorin, Bevacizumab) | 5 | 174 | |
| other | Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | Arm I (Oxaliplatin, Fluorouracil, Leucovorin) | 5 | 173 | |
| other | Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | Arm II (Oxaliplatin, Fluorouracil, Leucovorin, Bevacizumab) | 12 | 174 | |
| other | Anemia | Blood and lymphatic system disorders | Arm I (Oxaliplatin, Fluorouracil, Leucovorin) | 106 | 173 | |
| other | Anemia | Blood and lymphatic system disorders | Arm II (Oxaliplatin, Fluorouracil, Leucovorin, Bevacizumab) | 103 | 174 | |
| other | Leukocytes decreased | Investigations | Arm I (Oxaliplatin, Fluorouracil, Leucovorin) | 104 | 173 | |
| other | Leukocytes decreased | Investigations | Arm II (Oxaliplatin, Fluorouracil, Leucovorin, Bevacizumab) | 98 | 174 | |
| other | Lymphopenia | Investigations | Arm I (Oxaliplatin, Fluorouracil, Leucovorin) | 19 | 173 | |
| other | Lymphopenia | Investigations | Arm II (Oxaliplatin, Fluorouracil, Leucovorin, Bevacizumab) | 22 | 174 |
1 to 10 of 282Source ClinicalTrials.gov
See all 282 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm I (Oxaliplatin, Fluorouracil, Leucovorin) | ||
| Total, all-cause mortality | Arm II (Oxaliplatin, Fluorouracil, Leucovorin, Bevacizumab) | ||
| Total, other adverse events | Arm I (Oxaliplatin, Fluorouracil, Leucovorin) | 154 | 173 |
| Total, other adverse events | Arm II (Oxaliplatin, Fluorouracil, Leucovorin, Bevacizumab) | 155 | 174 |
| Total, serious adverse events | Arm I (Oxaliplatin, Fluorouracil, Leucovorin) | 119 | 173 |
| Total, serious adverse events | Arm II (Oxaliplatin, Fluorouracil, Leucovorin, Bevacizumab) | 123 | 174 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U10CA021115 | Eastern Cooperative Oncology Group Operations Office | COMIS, ROBERT L | FRONTIER SCI & TECHNOLOGY RSCH FDN, INC | NATIONAL CANCER INSTITUTE | 1985 to 2013 |
Source NIH RePORTER
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Arm I (Oxaliplatin, Fluorouracil, Leucovorin) vs Arm II (Oxaliplatin, Fluorouracil, Leucovorin, Bevacizumab): serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00303628
GET https://conductscience.org/api/trials/v1/NCT00303628/results?page=2