Colon Cancer Treated With Bevacizumab After Colon Surgery Clinical Trial
Official title:
Follow up to the AVANT Study up to 8 and 10 Years (Median Follow up) in Patients With Colon Carcinoma
| NCT number | NCT02228668 |
| Other study ID # | S-AVANT C13-1 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | March 2015 |
| Est. completion date | February 15, 2019 |
| Verified date | February 2019 |
| Source | GERCOR - Multidisciplinary Oncology Cooperative Group |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
The aim of the S-AVANT study is to collect additional data at 8 and 10 years median follow up
of patients previously included in the AVANT trial from December 2004 to June 2007.
Clinical data of the AVANT trial will be updated. Neither additional examination nor
administration of any treatment will be performed on the patients.
330 centers in 34 countries participated to the AVANT trial (Australia, Austria , Belgium,
Brazil, Bulgaria, Canada, China/Hong-Kong, Czeck Republic, Finland, France, Germany, Greece,
Hungary, Israël, Italy, Japan, Korean Republic, Mexico, Netherlands, New Zealand, Norway,
Panama, Poland, Portugal, Russia Federation, Singapore, South Africa, Spain, Sweden,
Switzerland, Taïwan, Thaïland, United Kingdom, U.S.A).
The AVANT study aiming at demonstrating superiority of bevacizumab in combination with
FOLFOX-4 or XELOX compared to FOLFOX-4, did not show prolongation of DFS at 3 year when
adding bevacizumab to chemotherapy in resected stage III colon cancer.
Adverse events were consistent with the known safety profile of bevacizumab. However, more
relapses and deaths due to disease progression have been observed in both bevacizumab arms.
A more prolonged follow-up is necessary to assess overall survival and to evaluate long-term
results and safety.
Collection of additional follow-up data will start Q3 2014. Clinical data are to be collected
at 8-year median follow-up (expected to be reached around Q2 2014) and at 10-year median
follow-up (expected to be reached around Q2 2016).
All analyses will be performed on an exploratory purpose only. An analysis at 8 years median
follow-up and a final analysis at 10 years median follow-up will be performed in the main
population (all randomized patients in the AVANT trial including patients lost to follow up
or died).
| Status | Completed |
| Enrollment | 1636 |
| Est. completion date | February 15, 2019 |
| Est. primary completion date | February 15, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - All patients randomized in the AVANT trial. Exclusion Criteria: - Written opposition from alive patients |
| Country | Name | City | State |
|---|---|---|---|
| France | GERCOR | Paris |
| Lead Sponsor | Collaborator |
|---|---|
| GERCOR - Multidisciplinary Oncology Cooperative Group | Hoffmann-La Roche |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Overall Survival (OS) up to 8 and 10 years median follow-up of the stage III population randomized in the AVANT study. | From randomization until 10 years median follow-up, assessed up to 5 years from the beginning of the S-AVANT study. | ||
| Secondary | Overall Survival (OS) in stage III patients at 8 years median follow-up in the subgroup of alive patients not lost to follow-up after the AVANT trial ending. | From randomization until 8 years median follow-up, assessed up to 3 years from the beginning of the S-AVANT study. | ||
| Secondary | Disease-Free Survival (DFS) in stage III patients at 8 and 10 years median follow-up. | From randomization until 10 years median follow-up, assessed up to 5 years from the beginning of the S-AVANT study. | ||
| Secondary | Relapse Free Survival (RFS) in patients with stage II and stage III colon cancer. | From randomization until first relapse, assessed up to 5 years from the beginning of the S-AVANT study. | ||
| Secondary | Cancer Specific Survival (CSS) in patients with stage II and stage III colon cancer. | From randomization until the date of death related to primary cancer or second primary colon cancer, assessed up to 5 years from the beginning of the S-AVANT study. |