A Study of Bevacizumab (Avastin) in Participants With Newly Diagnosed Locally Advanced Rectal Cancer
Trial · NCT00865189
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| 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 | |
| Secondary | Percentage of Participants With Surgery | Arm A: approximately 28-31 weeks after initiation of treatment; Arm B: approximately 13-15 weeks after initiation of treatment | The surgery involving a radical rectal excision using the TME technique. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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