Treatment After Irinotecan-based Frontline Therapy: Maintenance With Erbitux (in Patients wtRAS mCRC) (TIME)

March 23, 2022 updated by: UNICANCER

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

139

Phase

  • Phase 2

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

  • France
      • Amiens, France, 80054
        • CHU- Hôpital Sud
      • Angers, France, 49933
        • Centre Hospitalier Universitaire d'Angers
      • Auxerre, France, 89011
        • Centre Hospitalier d'Auxerre
      • Avignon, France, 84918
        • Institut Sainte Catherine
      • Bayonne, France, 64109
        • Centre Hospitalier Intercommunal Cote Basque
      • Beauvais, France, 60021
        • Centre Hospitalier de Beauvais
      • Blois, France, 41000
        • Centre Hospitalier de Blois
      • Bobigny, France, 93009
        • Hôpital Avicenne
      • Bordeaux, France, 33076
        • Institut Bergonié
      • Bordeaux, France, 33000
        • Clinqiue Tivoli
      • Béziers, France, 34500
        • Centre Hospitalier de Beziers
      • Caen, France, 14033
        • Hopital Cote de Nacre
      • Caen, France, 14033
        • Centre François Baclesse
      • Cahors, France, 46000
        • Centre Hospitalier Jean Rougier
      • Cahors, France
        • Centre Hospitalier Jean Rougier
      • Clermont-Ferrand, France, 63003
        • Centre Hospitalier Estaing
      • Dijon, France, 21079
        • Hopital Du Bocage
      • Draguignan, France, 83007
        • Centre Hospitalier de la Dracénie
      • Evry, France, 91035
        • Clinique Du Mousseau
      • Frejus, France, 83007
        • Centre Hospitalier Intercommunal
      • La Roche-sur-Yon, France, 85925
        • Centre Hospitalier Départemental de Vendée - Les Oudairies
      • La Seyne-sur-Mer, France, 83500
        • Clinique du Cap d'Or
      • Le Kremlin Bicêtre, France, 94275
        • Hôpital Bicêtre
      • Lille, France, 59020
        • Centre Oscar Lambret
      • Limoges, France, 87042
        • CHU de Limoges - Hôpital Dupuytren
      • Limoges, France, 87039
        • Clinique Francois Chenieux
      • Lyon, France, 69373
        • Centre Léon Bérard
      • Marseille, France, 13273
        • Institut Paoli Calmettes
      • Marseille, France, 13009
        • Hôpital Privé Clairval
      • Montelimar, France, 26216
        • Centre Hospitalier Montelimar
      • Montpellier, France, 34298
        • Institut régional du Cancer Montpellier
      • Montpellier, France, 34070
        • Centre de Cancérologie du Grand Montpellier - Clinique Clementville
      • Nice, France, 06189
        • Centre Antoine Lacassagne
      • Orléans, France, 45067
        • Centre Hospitalier d'Orléans La Source
      • Perigueux, France, 24004
        • Polyclinique Francheville
      • Perpignan, France, 66046
        • Hopital Saint Jean
      • Pierre Bénite, France, 69495
        • Centre Hospitalier Lyon Sud
      • Reims, France, 51092
        • CHU - Robert Debre
      • Romans, France, 26100
        • Centre Hospitalier de Romans
      • Roubaix, France, 59056
        • Centre Hospitalier Hôpital Victor Provo
      • Saint Gregoire, France, 35768
        • Hopital Saint Gregoire
      • Saint Nazaire, France, 44606
        • Clinique Mutualiste de l'Estuaire
      • Saint-Priest-en-Jarez, France, 42270
        • CHU Saint Etienne - Hopital Nord
      • Strasbourg, France, 67065
        • Centre Paul Strauss
      • Tarbes, France
        • Polyclinique de l'Ormeau
      • Toulon, France, 83056
        • Centre Hospitalier Intercommunal de Toulon
    • Ile De France
      • Villejuif, Ile De France, France, 94805
        • Gustave Roussy

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Histologically confirmed colorectal cancer
  2. KRAS and NRAS wild-type genes after analysis of mutation status from the primary tumour or metastasis
  3. Non resectable metastatic disease in a curative intent
  4. No prior chemotherapy except for fluoropyrimidines with or without oxaliplatin-based adjuvant treatment, at least 6 months before inclusion
  5. At least one measurable tumour target (higher than 20 mm) according to RECIST criteria, which has never been irradiated
  6. Life expectancy above 3 months
  7. Performance Status ≤2 (WHO)
  8. Patient ≥18 years-old
  9. Acceptable blood test
  10. Patient having signed a written informed consent form

Exclusion Criteria:

  1. Known and/or symptomatic brain metastases
  2. Known allergy to one of treatment components
  3. Neurological or psychiatric condition which could interfere with good treatment compliance
  4. Current anti-tumour treatment : chemotherapy or targeted therapy or radiotherapy ≤ 14 days before randomisation
  5. 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
  6. Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) 6 months before enrollment/randomization
  7. Concomitant severe infection
  8. 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.)
  9. Patient already included in another clinical trial with an investigational molecule
  10. Prior treatment with anti-EGFr antibodies (e.g. panitumumab (Vectibix® or cetuximab / Erbitux® ) or treatment with small EGFr inhibitor molecules (e.g., erlotinib / Tarceva®)
  11. 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
  12. Those deprived of their freedom or under guardianship
  13. Impossibility of undergoing trial's medical follow-up for geographical, social or psychological reasons

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A cetuximab
cetuximab 500 mg/m2 (every 2 weeks) until progression
Drug: Cetuximab
Drug: FOLFIRI and cetuximab
Other: Arm B observation
observation until progression
Drug: FOLFIRI and cetuximab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months after start of maintenance therapy

Collaborators and Investigators

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

Sponsor

UNICANCER

Investigators

  • Principal Investigator: Valérie BOIGE, Dr, Gustave Roussy, Cancer Campus, Grand Paris

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 (Actual)

November 22, 2013

Primary Completion (Actual)

November 1, 2020

Study Completion (Actual)

October 25, 2021

Study Registration Dates

First Submitted

March 23, 2015

First Submitted That Met QC Criteria

March 31, 2015

First Posted (Estimate)

April 1, 2015

Study Record Updates

Last Update Posted (Actual)

March 24, 2022

Last Update Submitted That Met QC Criteria

March 23, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Prodige 28 - UCGI 27 (TIME)
  • 2012-005139-99 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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