Colon Cancer Treated With Bevacizumab After Colon SurgeryNCT02228668
Follow up to the AVANT Study up to 8 and 10 Years (Median Follow up) in Patients With Colon Carcinoma
An observational study of Colon Cancer Treated With Bevacizumab After Colon Surgery, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer Treated With Bevacizumab After Colon Surgery
- How many people
- 1,636 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2015to 15 Feb 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- All patients randomized in the AVANT trial.
Who cannot join
- Written opposition from alive patients
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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).
- Keywords
- AVANT, GERCOR, Follow up, Colon cancer, Bevacizumab, Overall survival
- Medical subject headings
- Colonic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS) up to 8 and 10 years median follow-up of the stage III population randomized in the AVANT study.
Measured: From randomization until 10 years median follow-up, assessed up to 5 years from the beginning of the S-AVANT study.
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2014 (estimated)
- Study startMar 2015
- Primary completion15 Feb 2019
- Study completion15 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colon Cancer Treated With Bevacizumab After Colon SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,636 participants (actual)
Sponsor and investigators
- Lead sponsor
- GERCOR - Multidisciplinary Oncology Cooperative Group
- Sponsor type
- University, hospital or other
- Collaborators
- Hoffmann-La Roche
- Responsible party
- Sponsor
- Investigators
- Aimery de Gramont, Pr, Study director, GERCOR - Multidisciplinary Oncology Cooperative Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02228668
- Sponsor's protocol ID
- S-AVANT C13-1
- Status last verified
- Feb 2019
- First submitted
- 8 Aug 2014
- Last updated
- 27 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
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, Andre 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.
PubMed 33074326
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow up to the AVANT Study up to 8 and 10 Years (Median Follow up) in Patients With Colon Carcinoma
- ClinicalTrials.gov ID
- NCT02228668
- Acronym / sponsor ID
- S-AVANT C13-1
- Keywords
- AVANT, GERCOR, Follow up, Colon cancer, Bevacizumab, Overall survival
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,636 participants (actual)
- Lead sponsor
- GERCOR - Multidisciplinary Oncology Cooperative GroupUniversity, hospital or other
- Collaborators
- Hoffmann-La Roche
- Study start
- Mar 2015
- Primary completion
- 15 Feb 2019 (actual)
- Study completion
- 15 Feb 2019 (actual)
- First posted
- 29 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- All patients randomized in the AVANT trial.
Key exclusion criteria (1 listed)
- Written opposition from alive patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
4 secondary outcomes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2019.
- Derived from this study: PubMed 33074326Chibaudel 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, Andre 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aimery de Gramont, Pr study director
GERCOR - Multidisciplinary Oncology Cooperative Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colon Cancer Treated With Bevacizumab After Colon Surgery, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02228668, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2019.