Trial · NCT00865189
A Study of Bevacizumab (Avastin) in Participants With Newly Diagnosed Locally Advanced Rectal Cancer
NCT00865189, Phase 2, Completed, Hoffmann-La Roche; results first posted 2017-08-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Bevacizumab (Avastin) in Participants With Newly Diagnosed Locally Advanced Rectal Cancer. Trials, record NCT00865189. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00865189
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Bevacizumab (Avastin) in Participants With Newly Diagnosed Locally Advanced Rectal Cancer
- NCT number
- NCT00865189
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 91 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Rectal Cancer
- Interventions
- Bevacizumab, Oxaliplatin, Folinic Acid, 5-fluorouracil, Preoperative Radiotherapy, Surgery
- First posted
- 2009-03-19
- Last updated
- 2017-08-04
- Other registries' IDs
- eudract:2006-003472-35
- Results first posted
- 2017-08-04
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Tumor Sterilization Defined by ypT0-N0 | After surgery (Arm A: approximately 28-31 weeks after initiation of treatment; Arm B: approximately 13-15 weeks after initiation of treatment) | Tumor sterilization was defined as the absence of residual tumor cells in the resected specimen including lymph nodes (ypT0-N0). The rate of sterilization of the tumoral specimen was assessed after surgery on the surgical specimen by local review. Analyses were performed for participants who have been operated as defined by the protocol (within the study and TME technique) and for all participants who have been operated. Reported is the percentage of participants with tumor sterilization. |
| Secondary | Percentage of Participants With Tumor Down-Staging (ypT0-pT2) | After surgery (Arm A: approximately 28-31 weeks after initiation of treatment; Arm B: approximately 13-15 weeks after initiation of treatment) | A participant with a downstaging was defined as a participant with T3 (T describes the size of the original \[primary\] tumor) at inclusion and T2 or T1 or T0 after surgery, or with N+ (N describes lymph nodes involvement) at inclusion and N- after surgery and if T is equal at inclusion and after surgery. The clinical tumor-node-metastasis (cTNM) classification was used at inclusion and the pathological staging tumor and nodes (ypTN) classification after surgery. Reported is the percentage of participants with tumor downstaging of the surgical specimen according to the local review and centralized review. |
| Secondary | Percentage of Participants With Local and Distant Recurrences | After surgery (Arm A: approximately 28-31 weeks after initiation of treatment; Arm B: approximately 13-15 weeks after initiation of treatment) | The percentage of participants with a recurrence was described by type of recurrence (local and distant recurrence). |
| Secondary | Percentage of Participants With Second Cancer, Local or Regional Recurrence, Distant Metastasis, or Death | Baseline up to approximately 6 years | |
| Secondary | Disease-Free Survival (DFS) | From first time of the treatment administration to the date of second cancer, local or regional recurrence, distant metastasis or death from any cause (up to approximately 6 years) | The DFS was defined as the time from the first treatment intake to disease recurrence assessed (second primary cancer, local or distant recurrence, distant metastases) or death from any cause. The DFS was analyzed using Kaplan-Meier method. |
| Secondary | Percentage of Participants Who Died | Baseline up to approximately 6 years | |
| Secondary | Overall Survival | From the first treatment administration to the date of death (up to approximately 6 years) | The overall survival was defined as the time from the first treatment intake to death from any cause. |
| Secondary | Number of Cycles of Induction Chemotherapy | 6 cycles (12 weeks; cycle length = 14 days) | |
| Secondary | Number of Cycles of Chemotherapy | Arm A: Week 16 to Week 23; Arm B: Week 1 to Week 7 | |
| Secondary | Number of Cycles of Radiotherapy | Arm A: Week 16 to Week 23; Arm B: Week 1 to Week 7 |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Tumor Sterilization Defined by ypT0-N0 | After surgery (Arm A: approximately 28-31 weeks after initiation of treatment; Arm B: approximately 13-15 weeks after initiation of treatment) | ITT population. Here, number of participants analyzed = participants who were evaluable for this outcome. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Tumor Down-Staging (ypT0-pT2) | After surgery (Arm A: approximately 28-31 weeks after initiation of treatment; Arm B: approximately 13-15 weeks after initiation of treatment) | ITT population. Here, number of participants analyzed = participants who were evaluable for this outcome. n = participants who were evaluable for specified category. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Local and Distant Recurrences | After surgery (Arm A: approximately 28-31 weeks after initiation of treatment; Arm B: approximately 13-15 weeks after initiation of treatment) | ITT population | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Second Cancer, Local or Regional Recurrence, Distant Metastasis, or Death | Baseline up to approximately 6 years | ITT population | percentage of participants | NUMBER |
| SECONDARY | Disease-Free Survival (DFS) | From first time of the treatment administration to the date of second cancer, local or regional recurrence, distant metastasis or death from any cause (up to approximately 6 years) | ITT population | months | MEDIAN |
| SECONDARY | Percentage of Participants Who Died | Baseline up to approximately 6 years | ITT population | percentage of participants | NUMBER |
| SECONDARY | Overall Survival | From the first treatment administration to the date of death (up to approximately 6 years) | ITT population | months | MEDIAN |
| SECONDARY | Number of Cycles of Induction Chemotherapy | 6 cycles (12 weeks; cycle length = 14 days) | ITT population. Only Arm A participants received induction treatment. | cycles | MEAN |
| SECONDARY | Number of Cycles of Chemotherapy | Arm A: Week 16 to Week 23; Arm B: Week 1 to Week 7 | ITT population | cycles | MEAN |
| SECONDARY | Number of Cycles of Radiotherapy | Arm A: Week 16 to Week 23; Arm B: Week 1 to Week 7 | ITT population | cycles | MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group25
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Tumor Sterilization Defined by ypT0-N0 | Arm A (Bevacizumab, Induction Chemotherapy, Chemoradiotherapy) | 23.8 | 95% Confidence Interval 12.1 to 39.5 | percentage of participants | |
| Percentage of Participants With Tumor Sterilization Defined by ypT0-N0 | Arm B (Bevacizumab, Chemoradiotherapy) | 11.4 | 95% Confidence Interval 3.8 to 24.6 | percentage of participants | |
| Percentage of Participants With Tumor Down-Staging (ypT0-pT2) | Arm A (Bevacizumab, Induction Chemotherapy, Chemoradiotherapy) | Downstaging, local review (n=41, 44) | 65.9 | 95% Confidence Interval 51.3 to 80.4 | percentage of participants |
| Percentage of Participants With Tumor Down-Staging (ypT0-pT2) | Arm B (Bevacizumab, Chemoradiotherapy) | Downstaging, local review (n=41, 44) | 54.5 | 95% Confidence Interval 39.8 to 69.3 | percentage of participants |
| Percentage of Participants With Tumor Down-Staging (ypT0-pT2) | Arm A (Bevacizumab, Induction Chemotherapy, Chemoradiotherapy) | Downstaging, centralized review (n=39, 43) | 64.1 | 95% Confidence Interval 49.0 to 79.2 | percentage of participants |
| Percentage of Participants With Tumor Down-Staging (ypT0-pT2) | Arm B (Bevacizumab, Chemoradiotherapy) | Downstaging, centralized review (n=39, 43) | 55.8 | 95% Confidence Interval 41.0 to 70.7 | percentage of participants |
| Percentage of Participants With Local and Distant Recurrences | Arm A (Bevacizumab, Induction Chemotherapy, Chemoradiotherapy) | Local recurrence | 2.2 | 95% Confidence Interval 0.1 to 11.5 | percentage of participants |
| Percentage of Participants With Local and Distant Recurrences | Arm B (Bevacizumab, Chemoradiotherapy) | Local recurrence | 6.7 | 95% Confidence Interval 1.4 to 18.3 | percentage of participants |
| Percentage of Participants With Local and Distant Recurrences | Arm A (Bevacizumab, Induction Chemotherapy, Chemoradiotherapy) | Distant recurrence | 17.4 | 95% Confidence Interval 7.8 to 31.4 | percentage of participants |
| Percentage of Participants With Local and Distant Recurrences | Arm B (Bevacizumab, Chemoradiotherapy) | Distant recurrence | 13.3 | 95% Confidence Interval 5.1 to 26.8 | percentage of participants |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A (Bevacizumab, Induction Chemotherapy, Chemoradiotherapy) | 46 | |
| Overall Study | STARTED | Arm B (Bevacizumab, Chemoradiotherapy) | 45 | |
| Overall Study | COMPLETED | Arm A (Bevacizumab, Induction Chemotherapy, Chemoradiotherapy) | 34 | |
| Overall Study | COMPLETED | Arm B (Bevacizumab, Chemoradiotherapy) | 26 | |
| Overall Study | NOT COMPLETED | Arm A (Bevacizumab, Induction Chemotherapy, Chemoradiotherapy) | 12 | |
| Overall Study | NOT COMPLETED | Arm B (Bevacizumab, Chemoradiotherapy) | 19 |
Source ClinicalTrials.gov
Adverse events188
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 | Diarrhoea | Gastrointestinal disorders | Arm A (Bevacizumab, Induction Chemotherapy, Chemoradiotherapy) | 25 | 46 | |
| other | Diarrhoea | Gastrointestinal disorders | Arm B (Bevacizumab, Chemoradiotherapy) | 24 | 45 | |
| other | Nausea | Gastrointestinal disorders | Arm A (Bevacizumab, Induction Chemotherapy, Chemoradiotherapy) | 24 | 46 | |
| other | Nausea | Gastrointestinal disorders | Arm B (Bevacizumab, Chemoradiotherapy) | 7 | 45 | |
| other | Constipation | Gastrointestinal disorders | Arm A (Bevacizumab, Induction Chemotherapy, Chemoradiotherapy) | 15 | 46 | |
| other | Constipation | Gastrointestinal disorders | Arm B (Bevacizumab, Chemoradiotherapy) | 3 | 45 | |
| other | Abdominal pain | Gastrointestinal disorders | Arm A (Bevacizumab, Induction Chemotherapy, Chemoradiotherapy) | 7 | 46 | |
| other | Abdominal pain | Gastrointestinal disorders | Arm B (Bevacizumab, Chemoradiotherapy) | 5 | 45 | |
| other | Rectal haemorrhage | Gastrointestinal disorders | Arm A (Bevacizumab, Induction Chemotherapy, Chemoradiotherapy) | 9 | 46 | |
| other | Rectal haemorrhage | Gastrointestinal disorders | Arm B (Bevacizumab, Chemoradiotherapy) | 2 | 45 |
1 to 10 of 188Source ClinicalTrials.gov
See all 188 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A (Bevacizumab, Induction Chemotherapy, Chemoradiotherapy) | ||
| Total, all-cause mortality | Arm B (Bevacizumab, Chemoradiotherapy) | ||
| Total, other adverse events | Arm A (Bevacizumab, Induction Chemotherapy, Chemoradiotherapy) | 46 | 46 |
| Total, other adverse events | Arm B (Bevacizumab, Chemoradiotherapy) | 44 | 45 |
| Total, serious adverse events | Arm A (Bevacizumab, Induction Chemotherapy, Chemoradiotherapy) | 21 | 46 |
| Total, serious adverse events | Arm B (Bevacizumab, Chemoradiotherapy) | 18 | 45 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25122693 | DERIVED |
Source PubMed
Grants0
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.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Arm A (Bevacizumab, Induction Chemotherapy, Chemoradiotherapy) vs Arm B (Bevacizumab, Chemoradiotherapy): 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/NCT00865189
GET https://conductscience.org/api/trials/v1/NCT00865189/results?page=2