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Follow up to the AVANT Study up to 8 and 10 Years (Median Follow up) in Patients With Colon Carcinoma

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by (Responsible Party):
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
ClinicalTrials.gov Identifier:
NCT02228668
First received: August 8, 2014
Last updated: October 13, 2016
Last verified: November 2015
  Purpose

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
Colon Cancer Treated With Bevacizumab After Colon Surgery

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Follow up to the AVANT Study up to 8 and 10 Years (Median Follow up) in Patients With Colon Carcinoma

Further study details as provided by Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR):

Primary Outcome Measures:
  • 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. ]

Secondary Outcome Measures:
  • 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. ]

Estimated Enrollment: 3451
Study Start Date: March 2015
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • All patients randomized in the AVANT trial.

Exclusion Criteria:

  • Written opposition from alive patients
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02228668

Locations
France
GERCOR
Paris, France
Sponsors and Collaborators
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
Hoffmann-La Roche
Investigators
Study Director: Aimery de Gramont, Pr Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
  More Information

Additional Information:
Responsible Party: Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
ClinicalTrials.gov Identifier: NCT02228668     History of Changes
Other Study ID Numbers: S-AVANT C13-1
Study First Received: August 8, 2014
Last Updated: October 13, 2016

Keywords provided by Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR):
AVANT
GERCOR
Follow up
Colon cancer
Bevacizumab
Overall survival

Additional relevant MeSH terms:
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on June 22, 2017