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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Intergroupe Francophone de Cancerologie Thoracique
ClinicalTrials.gov Identifier:
NCT00775385
First received: October 17, 2008
Last updated: October 24, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Carcinoma, Non-Small-Cell Lung
Drug: Standard Chemotherapy
Drug: Customized Treatment
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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).

Resource links provided by NLM:


Further study details as provided by Intergroupe Francophone de Cancerologie Thoracique:

Primary Outcome Measures:
  • Feasibility (% of patients having started the treatment before 2 months after the surgery, with the biological results EGFR and ERCC1) [ Time Frame: week ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Disease-free Survival [ Time Frame: month ] [ Designated as safety issue: Yes ]

Enrollment: 152
Study Start Date: April 2009
Estimated Study Completion Date: December 2014
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00775385

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

Additional Information:
Publications:
Responsible Party: Intergroupe Francophone de Cancerologie Thoracique
ClinicalTrials.gov Identifier: NCT00775385     History of Changes
Other Study ID Numbers: IFCT-0801, Eudract : 2008-004939-38
Study First Received: October 17, 2008
Last Updated: October 24, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Intergroupe Francophone de Cancerologie Thoracique:
Chemotherapy, Adjuvant

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 22, 2014