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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 : Enrolling by invitation
First Posted : August 29, 2014
Last Update Posted : April 27, 2018
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by (Responsible Party):
GERCOR - Multidisciplinary Oncology Cooperative Group

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).


Condition or disease
Colon Cancer Treated With Bevacizumab After Colon Surgery

Study Type : Observational
Estimated Enrollment : 3451 participants
Observational Model: Cohort
Time Perspective: Other
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
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : January 2019



Primary Outcome Measures :
  1. 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 :
  1. 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. ]
  2. 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. ]
  3. 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. ]
  4. 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
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

Information from the National Library of Medicine

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


Locations
France
GERCOR
Paris, France
Sponsors and Collaborators
GERCOR - Multidisciplinary Oncology Cooperative Group
Hoffmann-La Roche
Investigators
Study Director: Aimery de Gramont, Pr GERCOR - Multidisciplinary Oncology Cooperative Group

Additional Information:
Responsible Party: GERCOR - Multidisciplinary Oncology Cooperative Group
ClinicalTrials.gov Identifier: NCT02228668     History of Changes
Other Study ID Numbers: S-AVANT C13-1
First Posted: August 29, 2014    Key Record Dates
Last Update Posted: April 27, 2018
Last Verified: December 2017

Keywords provided by GERCOR - Multidisciplinary Oncology Cooperative Group:
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