TAilored Post-Surgical Therapy in Early Stage NSCLC (TASTE)
This study is ongoing, but not recruiting participants.
Sponsor:
Intergroupe Francophone de Cancerologie Thoracique
Information provided by (Responsible Party):
Intergroupe Francophone de Cancerologie Thoracique
ClinicalTrials.gov Identifier:
NCT00775385
First received: October 17, 2008
Last updated: July 19, 2012
Last verified: July 2012
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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 ]
| Estimated Enrollment: | 165 |
| Study Start Date: | April 2009 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | September 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 :
|
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
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: | July 19, 2012 |
| 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 May 23, 2013