Colorectal CancerPhase 3NCT03362684
PETACC-8 miR-31-3p and miR-31-5p Ancillary Study
A Phase 3 study testing Cetuximab and FOLFOX in people with Colorectal Cancer, run by IntegraGen SA.
Trial summary
This is a prospective-retrospective study to determine if the expression of the miRNA's miR-31-3p and miR-31-5p are prognostic of patient outcomes or predictive of the benefit from anti-EGFR therapy in stage III Colon Cancer. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Cetuximab and FOLFOX
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,808 participants
- Where
- No sites listed yet
- Study dates
- Nov 2005to 30 Jun 2016
- Phase
- Phase 3
- 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 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient included in PETACC08 study
- Signed informed consent for translational study
- FFPE tumor sample available for miR-31-3p and miR-31-5p expression testing
Who cannot join
- Patient who have withdrawn their consent for PETACC08 and/or for PETACC08 translational study
About this study
Official title: Ancillary Study of miR-31-3p and miR-31-5p Expression Levels in Patients Enrolled in the PETACC-8 Study, and of the Predictive Role of miR-31-3p Expression Level on Clinical Outcomes of Patients Treated With Cetuximab
This is a prospective-retrospective study to determine if the expression of the miRNA's miR-31-3p and miR-31-5p are prognostic of patient outcomes or predictive of the benefit from anti-EGFR therapy in stage III Colon Cancer. The present study will utilize FFPE tumor samples collected from patients enrolled in the PETACC-8 study conducted by the Fédération Francophone de Cancérologie Digestive (FFCD). This phase 3 clinical trial prospectively randomized fully resected stage III colon cancer patients to receive adjuvant treatment with either FOLFOX-4 plus cetuximab or FLOFOX-4 alone.
- Conditions
- Colorectal Cancer
- Being tested
- Cetuximab, FOLFOX
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CetuximabDrug
Cetuximab every 2 weeks
FOLFOXDrug
FOLFOX-4 every 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| FOLFOX-4 plus Cetuximab | Experimental | Not described Receives: Drug: Cetuximab; Drug: FOLFOX |
| FOLFOX-4 | Active comparator | Not described Receives: Drug: FOLFOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Free Survival (DFS)
Difference in Disease Free Survival (DFS) for RAS/BRAF wild-type patients whose primary tumors have low miR-31-3p expression when treated with cetuximab plus FOLFOX-4 vs. FOLFOX-4 only .
Measured: From date of randomization until the date of first documented any signs or symptoms cancer relapse or date of death, whichever came first, assessed up to 7 years
Prognostic and predictive value of miR-31-3p expression on Disease Free Survival (DFS)
If patients with RAS/BRAF wild-type (WT), low miR-31-3p expression tumors treated with cetuximab plus FOLFOX-4 arm have improved DFS vs. patients treated with FOLFOX-4 alone, the predictive and prognostic value of miR-31-3p expression level on cetuximab efficacy relative to DFS in patients with RAS/BRAF WT tumors .
Measured: From date of randomization until the date of first documented any signs or symptoms cancer relapse or date of death, whichever came first, assessed up to 7 years
Secondary outcomes (4)
Overall Survival (OS)
Difference in OS for RAS/BRAF wild-type patients whose primary tumors have low miR-31-3p expression when treated with cetuximab plus FOLFOX-4 vs. FOLFOX-4 only.
Measured: From date of randomization until date of death from any cause, assessed up to 7 years
Prognostic and predictive value of miR-31-3p expression on OS
If patients with RAS/BRAF wild-type (WT), low miR-31-3p expression tumors treated with cetuximab plus FOLFOX-4 arm have improved OS vs. patients treated with FOLFOX-4 alone, the predictive and prognostic value of miR-31-3p expression level on cetuximab efficacy relative to OS in patients with RAS/BRAF WT tumors .
Measured: From date of randomization until date of death from any cause, assessed up to 7 years
Survival after recurrence (SAR)
Difference in Survival after Recurrence (SAR) for RAS/BRAF wild-type patients whose primary tumors have low miR-31-3p expression when treated with cetuximab plus FOLFOX-4 vs. FOLFOX-4 only.
Measured: From date of the first documented recurrence to the date of death from any cause, assessed up to 7 years
Prognostic and predictive value of miR-31-3p expression on SAR
If patients with RAS/BRAF wild-type (WT), low miR-31-3p expression tumors treated with cetuximab plus FOLFOX-4 arm have improved SAR vs. patients treated with FOLFOX-4 alone, the predictive and prognostic value of miR-31-3p expression level on cetuximab efficacy relative to SAR in patients with RAS/BRAF WT tumors .
Measured: From date of the first documented recurrence to the date of death from any cause, assessed up to 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2017
- Study startNov 2005
- Primary completionNov 2009
- Study completion30 Jun 2016
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 Colorectal CancerStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,808 participants (actual)
Sponsor and investigators
- Lead sponsor
- IntegraGen SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Federation Francophone de Cancerologie Digestive, Exystat
- Responsible party
- Sponsor
- Investigators
- Julien Taieb, MD, PhD, Principal investigator, Hôpital Européen Georges-PompidouPierre Laurent-Puig, MD, PhD, Principal investigator, Hôpital Européen Georges-Pompidou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03362684
- Sponsor's protocol ID
- IG2017001
- Status last verified
- Dec 2017
- First submitted
- 24 Nov 2017
- Last updated
- 5 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Taieb J, Tabernero J, Mini E, Subtil F, Folprecht G, Van Laethem JL, Thaler J, Bridgewater J, Petersen LN, Blons H, Collette L, Van Cutsem E, Rougier P, Salazar R, Bedenne L, Emile JF, Laurent-Puig P, Lepage C; PETACC-8 Study Investigators. Oxaliplatin, fluorouracil, and leucovorin with or without cetuximab in patients with resected stage III colon cancer (PETACC-8): an open-label, randomised phase 3 trial. Lancet Oncol. 2014 Jul;15(8):862-73. doi: 10.1016/S1470-2045(14)70227-X. Epub 2014 Jun 11.
PubMed 24928083
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ancillary Study of miR-31-3p and miR-31-5p Expression Levels in Patients Enrolled in the PETACC-8 Study, and of the Predictive Role of miR-31-3p Expression Level on Clinical Outcomes of Patients Treated With Cetuximab
- ClinicalTrials.gov ID
- NCT03362684
- Acronym / sponsor ID
- IG2017001
- Conditions
- Colorectal Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,808 participants (actual)
- Lead sponsor
- IntegraGen SAIndustry (pharma, biotech, devices)
- Collaborators
- Federation Francophone de Cancerologie Digestive, Exystat
- Study start
- Nov 2005 (actual)
- Primary completion
- Nov 2009 (actual)
- Study completion
- 30 Jun 2016 (actual)
- First posted
- 5 Dec 2017 (actual)
- 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.
This is a prospective-retrospective study to determine if the expression of the miRNA's miR-31-3p and miR-31-5p are prognostic of patient outcomes or predictive of the benefit from anti-EGFR therapy in stage III Colon Cancer. The present study will utilize FFPE tumor samples collected from patients enrolled in the PETACC-8 study conducted by the Fédération Francophone de Cancérologie Digestive (FFCD). This phase 3 clinical trial prospectively randomized fully resected stage III colon cancer patients to receive adjuvant treatment with either FOLFOX-4 plus cetuximab or FLOFOX-4 alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FOLFOX-4 plus Cetuximab | Experimental | Drug: Cetuximab, Drug: FOLFOX |
| FOLFOX-4 | Active comparator | Drug: FOLFOX |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient included in PETACC08 study
- Signed informed consent for translational study
- FFPE tumor sample available for miR-31-3p and miR-31-5p expression testing
Key exclusion criteria (1 listed)
- Patient who have withdrawn their consent for PETACC08 and/or for PETACC08 translational study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CetuximabCetuximab every 2 weeks | Drug | FOLFOX-4 plus Cetuximab |
| FOLFOXFOLFOX-4 every 2 weeks | Drug | FOLFOX-4, FOLFOX-4 plus Cetuximab |
Primary outcome
Disease Free Survival (DFS)
Time frame: From date of randomization until the date of first documented any signs or symptoms cancer relapse or date of death, whichever came first, assessed up to 7 years
Difference in Disease Free Survival (DFS) for RAS/BRAF wild-type patients whose primary tumors have low miR-31-3p expression when treated with cetuximab plus FOLFOX-4 vs. FOLFOX-4 only .
Prognostic and predictive value of miR-31-3p expression on Disease Free Survival (DFS)
Time frame: From date of randomization until the date of first documented any signs or symptoms cancer relapse or date of death, whichever came first, assessed up to 7 years
If patients with RAS/BRAF wild-type (WT), low miR-31-3p expression tumors treated with cetuximab plus FOLFOX-4 arm have improved DFS vs. patients treated with FOLFOX-4 alone, the predictive and prognostic value of miR-31-3p expression level on cetuximab efficacy relative to DFS in patients with RAS/BRAF WT tumors .
4 secondary outcomes
Overall Survival (OS)
Time frame: From date of randomization until date of death from any cause, assessed up to 7 years
Prognostic and predictive value of miR-31-3p expression on OS
Time frame: From date of randomization until date of death from any cause, assessed up to 7 years
Survival after recurrence (SAR)
Time frame: From date of the first documented recurrence to the date of death from any cause, assessed up to 7 years
Prognostic and predictive value of miR-31-3p expression on SAR
Time frame: From date of the first documented recurrence to the date of death from any cause, assessed up to 7 years
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 5 Dec 2017.
- Background: PubMed 24928083Taieb J, Tabernero J, Mini E, Subtil F, Folprecht G, Van Laethem JL, Thaler J, Bridgewater J, Petersen LN, Blons H, Collette L, Van Cutsem E, Rougier P, Salazar R, Bedenne L, Emile JF, Laurent-Puig P, Lepage C; PETACC-8 Study Investigators. Oxaliplatin, fluorouracil, and leucovorin with or without cetuximab in patients with resected stage III colon cancer (PETACC-8): an open-label, randomised phase 3 trial. Lancet Oncol. 2014 Jul;15(8):862-73. doi: 10.1016/S1470-2045(14)70227-X. Epub 2014 Jun 11.
- Individual participant dataSharing planned: No
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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.
Julien Taieb, MD, PhD principal investigator
Hôpital Européen Georges-Pompidou
Pierre Laurent-Puig, MD, PhD principal investigator
Hôpital Européen Georges-Pompidou
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cetuximab and FOLFOX in people with Colorectal Cancer, run by IntegraGen SA.
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 3 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 5 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Disease Free Survival (DFS) (time frame: From date of randomization until the date of first documented any signs or symptoms cancer relapse or date of death, whichever came first, assessed up to 7 years). The study lists 2 primary outcomes in all. 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 NCT03362684, 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 5 Dec 2017.