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

February 26, 2019 updated by: GERCOR - Multidisciplinary Oncology Cooperative Group

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).

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

1636

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

  • All patients randomized in the AVANT trial.

Exclusion Criteria:

  • Written opposition from alive patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
From randomization until 10 years median follow-up, assessed up to 5 years from the beginning of the S-AVANT study.

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
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.
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.
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GERCOR - Multidisciplinary Oncology Cooperative Group

Collaborators

Hoffmann-La Roche

Investigators

  • Study Director: Aimery de Gramont, Pr, GERCOR - Multidisciplinary Oncology Cooperative Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

February 15, 2019

Study Completion (Actual)

February 15, 2019

Study Registration Dates

First Submitted

August 8, 2014

First Submitted That Met QC Criteria

August 27, 2014

First Posted (Estimate)

August 29, 2014

Study Record Updates

Last Update Posted (Actual)

February 27, 2019

Last Update Submitted That Met QC Criteria

February 26, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S-AVANT C13-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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