Metastatic Colorectal CancerPhase 2TIMENCT02404935
Treatment After Irinotecan-based Frontline Therapy: Maintenance With Erbitux (in Patients wtRAS mCRC)
A Phase 2 study testing Cetuximab and FOLFIRI and cetuximab in people with Metastatic Colorectal Cancer, run by UNICANCER at 47 sites in France.
Trial summary
National multicentric phase II trial evaluating whether single agent cetuximab is effective as maintenance therapy after 8 cycles of first line FOLFIRI plus cetuximab in mCRC patients with KRAS and NRAS wild-type genes, assessed by progression-free survival at 6 months after start of maintenance therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- Cetuximab and FOLFIRI and cetuximab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- 47 sitesFrance
- Study dates
- 22 Nov 2013to 25 Oct 2021
- Phase
- Phase 2
- 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
Who may be able to join
- Histologically confirmed colorectal cancer
- KRAS and NRAS wild-type genes after analysis of mutation status from the primary tumour or metastasis
- Non resectable metastatic disease in a curative intent
- No prior chemotherapy except for fluoropyrimidines with or without oxaliplatin-based adjuvant treatment, at least 6 months before inclusion
- At least one measurable tumour target (higher than 20 mm) according to RECIST criteria, which has never been irradiated
- Life expectancy above 3 months
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- Performance Status ≤2 (WHO)
- Patient ≥18 years-old
- Acceptable blood test
- Patient having signed a written informed consent form
Who cannot join
- Known and/or symptomatic brain metastases
- Known allergy to one of treatment components
- Neurological or psychiatric condition which could interfere with good treatment compliance
- Current anti-tumour treatment : chemotherapy or targeted therapy or radiotherapy ≤ 14 days before randomisation
- Other severe conditions such as: respiratory failure. History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan
- Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) 6 months before enrollment/randomization
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- Concomitant severe infection
- History of cancer (except skin cancer other than melanoma or an in situ cervical epithelioma or other solid tumour treated for curative purposes without signs of the condition and with no treatment administered in the 5 years before randomisation.)
- Patient already included in another clinical trial with an investigational molecule
- Prior treatment with anti-EGFr antibodies (e.g. panitumumab (Vectibix® or cetuximab / Erbitux® ) or treatment with small EGFr inhibitor molecules (e.g., erlotinib / Tarceva®)
- Pregnant female, likely to be or currently breastfeeding, or planning to become pregnant within 6 months after the end of treatment or absence of effective contraception for males and females of childbearing age during treatment and for 6 months (male or female) after the end of treatment
- Those deprived of their freedom or under guardianship
- Impossibility of undergoing trial's medical follow-up for geographical, social or psychological reasons
Trial locations and contacts
47 sites in 1 country.
47 sites in 1 country
France47 sites
CHU- Hôpital Sud
Amiens, 80054
Centre Hospitalier Universitaire d'Angers
Angers, 49933
Centre Hospitalier d'Auxerre
Auxerre, 89011
Institut Sainte Catherine
Avignon, 84918
Centre Hospitalier Intercommunal Cote Basque
Bayonne, 64109
Centre Hospitalier de Beauvais
Beauvais, 60021
Centre Hospitalier de Béziers
Béziers, 34500
Centre Hospitalier de Blois
Blois, 41000
Hôpital Avicenne
Bobigny, 93009
Clinqiue Tivoli
Bordeaux, 33000
Institut Bergonie
Bordeaux, 33076
Centre François Baclesse
Caen, 14033
Hôpital Côte de nacre
Caen, 14033
Centre Hospitalier Jean Rougier
Cahors, 46000
Centre Hospitalier Jean Rougier
Cahors
Centre Hospitalier Estaing
Clermont-Ferrand, 63003
Hôpital du Bocage
Dijon, 21079
Centre Hospitalier de la Dracénie
Draguignan, 83007
Clinique du Mousseau
Évry, 91035
Centre Hospitalier Intercommunal
Fréjus, 83007
Centre hospitalier Départemental de Vendée - Les Oudairies
La Roche-sur-Yon, 85925
Clinique du Cap d'Or
La Seyne-sur-Mer, 83500
Hôpital Bicêtre
Le Kremlin-Bicêtre, 94275
Centre Oscar Lambret
Lille, 59020
Clinique Francois Chenieux
Limoges, 87039
CHU de Limoges - Hôpital Dupuytren
Limoges, 87042
Centre Léon Bérard
Lyon, 69373
Hôpital Privé Clairval
Marseille, 13009
Institut Paoli Calmettes
Marseille, 13273
Centre Hospitalier Montelimar
Montélimar, 26216
Centre de Cancérologie du Grand Montpellier - Clinique Clementville
Montpellier, 34070
Institut régional du Cancer Montpellier
Montpellier, 34298
Centre Antoine Lacassagne
Nice, 06189
Centre Hospitalier d'Orléans La Source
Orléans, 45067
Polyclinique Francheville
Périgueux, 24004
Hôpital Saint Jean
Perpignan, 66046
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495
CHU - Robert Debre
Reims, 51092
Centre Hospitalier de Romans
Romans, 26100
Centre Hospitalier Hôpital Victor Provo
Roubaix, 59056
Hôpital Saint Gregoire
Saint-Grégoire, 35768
Clinique Mutualiste de l'Estuaire
Saint-Nazaire, 44606
CHU Saint Etienne - Hôpital Nord
Saint-Priest-en-Jarez, 42270
Centre Paul Strauss
Strasbourg, 67065
Polyclinique de l'Ormeau
Tarbes
Centre Hospitalier Intercommunal de Toulon
Toulon, 83056
Gustave Roussy
Villejuif, Île-de-France Region, 94805
About this study
Official title: Randomized Phase II Study of First-line FOLFIRI Plus Cetuximab for 8 Cycles Followed by Either Single-agent Cetuximab as Maintenance Therapy or Observation in Patients With Wild-type KRAS and NRAS Metastatic Colorectal Cancer
National multicentric phase II trial evaluating whether single agent cetuximab is effective as maintenance therapy after 8 cycles of first line FOLFIRI plus cetuximab in mCRC patients with KRAS and NRAS wild-type genes, assessed by progression-free survival at 6 months after start of maintenance therapy.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- Cetuximab, FOLFIRI and cetuximab
- Keywords
- Metastatic colorectal cancer, cetuximab, maintenance
- 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
FOLFIRI and cetuximabDrug
| Study group | Role | What they receive |
|---|---|---|
| Arm A cetuximab | Experimental | cetuximab 500 mg/m2 (every 2 weeks) until progression Receives: Drug: Cetuximab; Drug: FOLFIRI and cetuximab |
| Arm B observation | Other | observation until progression Receives: Drug: FOLFIRI and cetuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival at 6 months
Endpoints will include Progression assessed by CT Scan according to RECIST 1.1 criteria and Death from any cause
Measured: 6 months after start of maintenance therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2015 (estimated)
- Study start22 Nov 2013
- Primary completion1 Nov 2020
- Study completion25 Oct 2021
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 Metastatic Colorectal CancerStudies of the same condition, open and under way.
- More trials run by UNICANCERThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNICANCER
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Valérie Boige, Dr, Principal investigator, Gustave Roussy, Cancer Campus, Grand Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02404935
- Sponsor's protocol ID
- Prodige 28 - UCGI 27 (TIME)
- Other IDs
- 2012-005139-99
- Acronym
- TIME
- Status last verified
- Mar 2022
- First submitted
- 23 Mar 2015
- Last updated
- 24 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Boige V, Blons H, Francois E, Ben Abdelghani M, Phelip JM, Le Brun-Ly V, Mineur L, Galais MP, Villing AL, Hautefeuille V, Miglianico L, De La Fouchardiere C, Genet D, Levasseur N, Levache CB, Penel N, Mitry E, Jacquot S, Aparicio T, Brument E, Gourgou S, Castan F, Bouche O. Maintenance Therapy With Cetuximab After FOLFIRI Plus Cetuximab for RAS Wild-Type Metastatic Colorectal Cancer: A Phase 2 Randomized Clinical Trial. JAMA Netw Open. 2023 Sep 5;6(9):e2333533. doi: 10.1001/jamanetworkopen.2023.33533.
PubMed 37721754
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase II Study of First-line FOLFIRI Plus Cetuximab for 8 Cycles Followed by Either Single-agent Cetuximab as Maintenance Therapy or Observation in Patients With Wild-type KRAS and NRAS Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT02404935
- Acronym / sponsor ID
- TIME / Prodige 28 - UCGI 27 (TIME)
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- Metastatic colorectal cancer, cetuximab, maintenance
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- UNICANCERUniversity, hospital or other
- Study start
- 22 Nov 2013 (actual)
- Primary completion
- 1 Nov 2020 (actual)
- Study completion
- 25 Oct 2021 (actual)
- First posted
- 1 Apr 2015 (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.
National multicentric phase II trial evaluating whether single agent cetuximab is effective as maintenance therapy after 8 cycles of first line FOLFIRI plus cetuximab in mCRC patients with KRAS and NRAS wild-type genes, assessed by progression-free survival at 6 months after start of maintenance therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A cetuximab | Experimental | Drug: Cetuximab, Drug: FOLFIRI and cetuximabcetuximab 500 mg/m2 (every 2 weeks) until progression |
| Arm B observation | Other | Drug: FOLFIRI and cetuximabobservation until progression |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologically confirmed colorectal cancer
- KRAS and NRAS wild-type genes after analysis of mutation status from the primary tumour or metastasis
- Non resectable metastatic disease in a curative intent
- No prior chemotherapy except for fluoropyrimidines with or without oxaliplatin-based adjuvant treatment, at least 6 months before inclusion
- At least one measurable tumour target (higher than 20 mm) according to RECIST criteria, which has never been irradiated
Key exclusion criteria (13 listed)
- Known and/or symptomatic brain metastases
- Known allergy to one of treatment components
- Neurological or psychiatric condition which could interfere with good treatment compliance
- Current anti-tumour treatment : chemotherapy or targeted therapy or radiotherapy ≤ 14 days before randomisation
- Other severe conditions such as: respiratory failure. History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan
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 |
|---|---|---|
| Cetuximab | Drug | Arm A cetuximab |
| FOLFIRI and cetuximab | Drug | Arm A cetuximab, Arm B observation |
Primary outcome
Progression Free Survival at 6 months
Time frame: 6 months after start of maintenance therapy
Endpoints will include Progression assessed by CT Scan according to RECIST 1.1 criteria and Death from any cause
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 24 Mar 2022.
- Derived from this study: PubMed 37721754Boige V, Blons H, Francois E, Ben Abdelghani M, Phelip JM, Le Brun-Ly V, Mineur L, Galais MP, Villing AL, Hautefeuille V, Miglianico L, De La Fouchardiere C, Genet D, Levasseur N, Levache CB, Penel N, Mitry E, Jacquot S, Aparicio T, Brument E, Gourgou S, Castan F, Bouche O. Maintenance Therapy With Cetuximab After FOLFIRI Plus Cetuximab for RAS Wild-Type Metastatic Colorectal Cancer: A Phase 2 Randomized Clinical Trial. JAMA Netw Open. 2023 Sep 5;6(9):e2333533. doi: 10.1001/jamanetworkopen.2023.33533.
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CRC
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.
Valérie Boige, Dr principal investigator
Gustave Roussy, Cancer Campus, Grand Paris
47 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cetuximab and FOLFIRI and cetuximab in people with Metastatic Colorectal Cancer, run by UNICANCER at 47 sites 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 10 inclusion and 13 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 24 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 47 sites 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Progression Free Survival at 6 months (time frame: 6 months after start of maintenance therapy). 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 NCT02404935, 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 24 Mar 2022; AzTrials last refreshed its copy on 7 Nov 2026.