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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
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by (Responsible Party):
GERCOR - Multidisciplinary Oncology Cooperative Group

Tracking Information
First Submitted Date August 8, 2014
First Posted Date August 29, 2014
Last Update Posted Date February 27, 2019
Study Start Date March 2015
Actual Primary Completion Date February 15, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 27, 2014)
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. ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: August 27, 2014)
  • 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. ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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).

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Colon Cancer Treated With Bevacizumab After Colon Surgery
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * 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, André 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. Erratum in: JAMA Netw Open. 2021 Feb 1;4(2):e210700.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 26, 2019)
1636
Original Estimated Enrollment
 (submitted: August 27, 2014)
3451
Actual Study Completion Date February 15, 2019
Actual Primary Completion Date February 15, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • All patients randomized in the AVANT trial.

Exclusion Criteria:

  • Written opposition from alive patients
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT02228668
Other Study ID Numbers S-AVANT C13-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party GERCOR - Multidisciplinary Oncology Cooperative Group
Original Responsible Party Same as current
Current Study Sponsor GERCOR - Multidisciplinary Oncology Cooperative Group
Original Study Sponsor Same as current
Collaborators Hoffmann-La Roche
Investigators
Study Director: Aimery de Gramont, Pr GERCOR - Multidisciplinary Oncology Cooperative Group
PRS Account GERCOR - Multidisciplinary Oncology Cooperative Group
Verification Date February 2019