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History of Changes for Study: NCT02228668
Follow up to the AVANT Study up to 8 and 10 Years (Median Follow up) in Patients With Colon Carcinoma
Latest version (submitted February 26, 2019) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 August 27, 2014 None (earliest Version on record)
2 January 9, 2015 Study Status
3 March 30, 2015 Recruitment Status, Study Status and Contacts/Locations
4 December 10, 2015 Study Status
5 May 10, 2016 Recruitment Status, Study Status and Contacts/Locations
6 October 13, 2016 Study Description and Study Status
7 December 22, 2017 Study Status and Study Design
8 April 26, 2018 Study Status
9 February 26, 2019 Recruitment Status, Study Status and Study Design
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Study NCT02228668
Submitted Date:  August 27, 2014 (v1)

Open or close this module Study Identification
Unique Protocol ID: S-AVANT C13-1
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
Secondary IDs:
Open or close this module Study Status
Record Verification: August 2014
Overall Status: Not yet recruiting
Study Start: October 2014
Primary Completion: March 2016 [Anticipated]
Study Completion: January 2017 [Anticipated]
First Submitted: August 8, 2014
First Submitted that
Met QC Criteria:
August 27, 2014
First Posted: August 29, 2014 [Estimate]
Last Update Submitted that
Met QC Criteria:
August 27, 2014
Last Update Posted: August 29, 2014 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group
Responsible Party: Sponsor
Collaborators: Hoffmann-La Roche
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
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.

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:
Open or close this module Conditions
Conditions: Colon Cancer Treated With Bevacizumab After Colon Surgery
Keywords: AVANT
GERCOR
Follow up
Colon cancer
Bevacizumab
Overall survival
Open or close this module Study Design
Study Type: Observational
Observational Study Model: Cohort
Time Perspective:
Biospecimen Retention:
Biospecimen Description:
Enrollment: 3451 [Anticipated]
Number of Groups/Cohorts 0
Open or close this module Groups and Interventions
Open or close this module Outcome Measures
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. ]

Open or close this module Eligibility
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.
Sampling Method: Non-Probability Sample
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • All patients randomized in the AVANT trial.

Exclusion Criteria:

  • Written opposition from alive patients
Open or close this module Contacts/Locations
Central Contact Person: Kelly Lutchia
Telephone: +33 1 40 29 83 94
Email: kelly.lutchia@gercor.com.fr
Study Officials: Aimery de Gramont, Pr
Study Director
GERCOR - Multidisciplinary Oncology Cooperative Group
Locations: France
GERCOR
Paris, France
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links: Description: Related Info
Available IPD/Information:

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