Follow up to the AVANT Study up to 8 and 10 Years (Median Follow up) in Patients With Colon Carcinoma
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|ClinicalTrials.gov Identifier: NCT02228668|
Recruitment Status : Completed
First Posted : August 29, 2014
Last Update Posted : February 27, 2019
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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).
|Condition or disease|
|Colon Cancer Treated With Bevacizumab After Colon Surgery|
|Study Type :||Observational|
|Actual Enrollment :||1636 participants|
|Official Title:||Follow up to the AVANT Study up to 8 and 10 Years (Median Follow up) in Patients With Colon Carcinoma|
|Study Start Date :||March 2015|
|Actual Primary Completion Date :||February 15, 2019|
|Actual Study Completion Date :||February 15, 2019|
- Overall Survival (OS) up to 8 and 10 years median follow-up of the stage III population randomized in the AVANT study. [ Time Frame: From randomization until 10 years median follow-up, assessed up to 5 years from the beginning of the S-AVANT study. ]
- 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. [ Time Frame: From randomization until 8 years median follow-up, assessed up to 3 years from the beginning of the S-AVANT study. ]
- Disease-Free Survival (DFS) in stage III patients at 8 and 10 years median follow-up. [ Time Frame: From randomization until 10 years median follow-up, assessed up to 5 years from the beginning of the S-AVANT study. ]
- Relapse Free Survival (RFS) in patients with stage II and stage III colon cancer. [ Time Frame: From randomization until first relapse, assessed up to 5 years from the beginning of the S-AVANT study. ]
- Cancer Specific Survival (CSS) in patients with stage II and stage III colon cancer. [ Time Frame: 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. ]
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
Patients with colon cancer included in the AVANT trial and who were randomized between the three arms of treatment:
- ARM A: (FOLFOX-4): Oxaliplatin, leucovorin (LV) and 5-fluorouracil (5-FU).
- ARM B: (FOLFOX-4+bev): Bevacizumab, oxaliplatin, leucovorin (LV) and 5-fluorouracil (5-FU).
- ARM C: (XELOX+ bev): Bevacizumab, oxaliplatin in combination with capecitabine.
- All patients randomized in the AVANT trial.
- Written opposition from alive patients
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02228668
|Study Director:||Aimery de Gramont, Pr||GERCOR - Multidisciplinary Oncology Cooperative Group|
|Responsible Party:||GERCOR - Multidisciplinary Oncology Cooperative Group|
|Other Study ID Numbers:||
|First Posted:||August 29, 2014 Key Record Dates|
|Last Update Posted:||February 27, 2019|
|Last Verified:||February 2019|
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases