TAilored Post-Surgical Therapy in Early Stage NSCLC (TASTE)

March 1, 2017 updated by: Intergroupe Francophone de Cancerologie Thoracique

Randomized Phase II/III Adjuvant Trial Evaluating Feasibility of Standard (A) vs. Customized Treatment (B) in Stage II or Stage IIIA Non-N2, Non-squamous Non Small Cell Lung Cancer (NSCLC).

Our hypothesis is that patients receiving therapy based on their baseline tumor ERCC1 levels and EGFR mutations would attain better disease free survival rates than patients in the control arm receiving noncustomized therapy. Using this selective approach, patients with stage II and IIIA non N2 NSCLC in the genotypic arm with low ERCC1 levels will receive cisplatin plus pemetrexed, and those with high ERCC1 levels will not receive cisplatin-based chemotherapy. If they harbor EGRF mutations they will be treated with erlotinib.

The study will be restricted to non-squamous NSCLC for two mains reasons. First, this will enrich the EGFR mutation rate that is awaited to be higher in these tumors than in squamous cell carcinoma. Second, permetrexed cisplatin combination has a promising efficacy and favorable toxicity profile and is of potential interest in the adjuvant setting of resected non-squamous NSCLC.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

152

Phase

  • Phase 2
  • Phase 3

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
      • Aix en Provence, France
        • Centre Hospitalier
      • Amiens, France
        • Clinique de l'Europe
      • Angers, France, 49000
        • Angers - CHU
      • Béziers, France
        • Centre Hospitalier
      • Caen, France, 14000
        • Centre F. Baclesse
      • Caen, France, 14000
        • CHU - Pneumologie
      • Chauny, France
        • Centre Hospitalier
      • Chevilly Larue, France
        • Chevilly Larue - CH
      • Clamart, France, 92140
        • Hôpital Percy-Armées - Pneumologie
      • Clermont Ferrand, France, 63000
        • Clermont Ferrand - CHU
      • Colmar, France, 68000
        • Colmar - CH
      • Dax, France, 40107
        • Dax - CH
      • Ermont, France
        • Ermont - Clinique Claude Bernard
      • Grenoble, France, 38000
        • CHU Grenoble - pneumologie
      • Le Mans, France
        • Le Mans - CHG
      • Lyon, France, 69000
        • Centre Léon Bérard
      • Lyon, France
        • Lyon - Hôpital Louis Pradel (Pneumologie)
      • Mantes La Jolie, France, 78200
        • Mantes La Jolie - CH
      • Marseille, France
        • Institut Paoli Calmette
      • Marseille, France, 13000
        • APHM - Hôpital Sainte Marguerite
      • Metz, France
        • Metz - Belle Isle
      • Mont de Marsan, France, 40000
        • Mont de Marsan - CH
      • Montpellier, France, 34070
        • Montpellier - Clinique Clémentville
      • Mulhouse, France, 68000
        • Mulhouse - CH
      • Nancy, France
        • Nancy - Polyclinique Gentilly
      • Nevers, France, 58033
        • Nevers - CH
      • Paris, France, 75000
        • Paris - Saint Louis
      • Paris, France, 75020
        • APHP - Hopital Tenon - Pneumologie
      • Pau, France, 64046
        • Pau - CH
      • Pierre Bénite, France, 69495
        • HCL - Lyon Sud (Pneumologie)
      • Reims, France, 51092
        • Reims - CHU
      • Rennes, France
        • Rennes - CHU
      • Saint-Quentin, France
        • Centre Hospitalier
      • Strasbourg, France, 63000
        • Nouvel Hopital Civil
      • Suresnes, France
        • Hopital Foch
      • Toulon, France
        • Centre Hospitalier Intercommunal
      • Toulouse, France
        • CHU Toulouse - Pneumologie
      • Toulouse, France
        • Clinique Pasteur
      • Tours, France, 37000
        • Tours - CHU
      • Vandoeuvre lès Nancy, France, 54500
        • Nancy - CHU
      • Villejuif, France, 94805
        • Institut Gustave Roussy
      • Villeneuve-Saint-Georges, France
        • Centre Hospitalier Intercommunal

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

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • NSCLC that is defined as other than predominantly squamous cell histology (squamous cell and/or mixed small cell, non-small cell histology is not permitted)
  • Surgically resected NSCLC with pathological stage II or stage IIIA non-N2 (TNM classification 2008)
  • Performance status (PS) = 0 or 1
  • 18 years <= age < 70 years
  • Signed inform consent

Exclusion Criteria:

  • Squamous cell carcinoma
  • Previous cancer excepted those treated for more than 5 years and considered cured, basocellular skin carcinoma, carcinoma in situ of uterine cervix
  • Inadequate renal or cardiac functions
  • Pregnant women
  • Any of the following within 6 months prior to study enrollment: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, NYHA class III or IV congestive heart failure, cerebrovascular accident or transient ischemic attack, grade ≥ 2 peripheral neuropathy, peptic ulcer disease, erosive esophagitis or gastritis

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
Active Comparator: A
Standard chemotherapy
Drug: Standard Chemotherapy
Pemetrexed Cisplatin Schedule : CDDP 75 mg/m² D1, pemetrexed 500 mg/m² D1 D1=D21, 4 cycles
Experimental: B
Customized treatment
Drug: Customized Treatment

Mutated EGFR : Erlotinib 150mg/day (1 year)

Wild-type EGFR or "undetermined" depends on ERCC1 status :

  • ERCC1 high : no treatment
  • ERCC1 low or undetermined : Pemetrexed Cisplatin, 4 cycles (63 days)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Feasibility (% of patients having started the treatment before 2 months after the surgery, with the biological results EGFR and ERCC1)
Time Frame: week
week

Secondary Outcome Measures

Outcome Measure
Time Frame
Disease-free Survival
Time Frame: month
month

Collaborators and Investigators

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

Sponsor

Intergroupe Francophone de Cancerologie Thoracique

Investigators

  • Principal Investigator: Jean-Charles SORIA, Pr, Institut Gustave Roussy (Igr)
  • Principal Investigator: Marie Wislez, Pr, APHP - Hôpital Tenon (Paris)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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

April 1, 2009

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

January 21, 2016

Study Registration Dates

First Submitted

October 17, 2008

First Submitted That Met QC Criteria

October 17, 2008

First Posted (Estimate)

October 20, 2008

Study Record Updates

Last Update Posted (Actual)

March 3, 2017

Last Update Submitted That Met QC Criteria

March 1, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IFCT-0801
  • Eudract : 2008-004939-38

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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