Clinical trial NCT02228668: Follow up to the AVANT Study up to 8 and 10 Years (Median Follow up) in Patients With Colon Carcinoma
Official title: Follow up to the AVANT Study up to 8 and 10 Years (Median Follow up) in Patients With Colon Carcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colon Cancer Treated With Bevacizumab After Colon Surgery
Keywords: AVANT
GERCOR
Follow up
Colon cancer
Bevacizumab
Overall survival
Lead sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group
Sponsor class: OTHER
Collaborators: name: Hoffmann-La Roche
First posted: 2014-08-29
Enrollment: 1636
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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).


Eligibility criteria: Inclusion Criteria:

* All patients randomized in the AVANT trial.

Exclusion Criteria:

* Written opposition from alive patients

Primary outcomes:
measure: Overall Survival (OS) up to 8 and 10 years median follow-up of the stage III population randomized in the AVANT study.
timeFrame: From randomization until 10 years median follow-up, assessed up to 5 years from the beginning of the S-AVANT study.
Secondary outcomes:
measure: 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.
timeFrame: From randomization until 8 years median follow-up, assessed up to 3 years from the beginning of the S-AVANT study.
measure: Disease-Free Survival (DFS) in stage III patients at 8 and 10 years median follow-up.
timeFrame: From randomization until 10 years median follow-up, assessed up to 5 years from the beginning of the S-AVANT study.
measure: Relapse Free Survival (RFS) in patients with stage II and stage III colon cancer.
timeFrame: From randomization until first relapse, assessed up to 5 years from the beginning of the S-AVANT study.
measure: Cancer Specific Survival (CSS) in patients with stage II and stage III colon cancer.
timeFrame: 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.
Other outcomes:
Locations:
city: Paris
country: France
facility: GERCOR
Study officials:
affiliation: GERCOR - Multidisciplinary Oncology Cooperative Group
name: Aimery de Gramont, Pr
role: STUDY_DIRECTOR
References:
citation: Chibaudel B, Henriques J, Rakez M, Brenner B, Kim TW, Martinez-Villacampa M, Gallego-Plazas J, Cervantes A, Shim K, Jonker D, Guerin-Meyer V, Mineur L, Banzi C, Dewdney A, Dejthevaporn T, Bloemendal HJ, Roth A, Moehler M, Aranda E, Van Cutsem E, Tabernero J, Schmoll HJ, Hoff PM, Andre T, de Gramont A. Association of Bevacizumab Plus Oxaliplatin-Based Chemotherapy With Disease-Free Survival and Overall Survival in Patients With Stage II Colon Cancer: A Secondary Analysis of the AVANT Trial. JAMA Netw Open. 2020 Oct 1;3(10):e2020425. doi: 10.1001/jamanetworkopen.2020.20425.