TAilored Post-Surgical Therapy in Early Stage NSCLC (TASTE)
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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 Intervention Model: Parallel Assignment Masking: None (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). |
- Feasibility (% of patients having started the treatment before 2 months after the surgery, with the biological results EGFR and ERCC1) [ Time Frame: week ]
- Disease-free Survival [ Time Frame: month ]
| Enrollment: | 152 |
| Study Start Date: | April 2009 |
| Study Completion Date: | January 21, 2016 |
| Primary Completion Date: | April 2013 (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
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, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00775385
| 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 | |
| Centre Léon Bérard | |
| Lyon, France, 69000 | |
| Lyon - Hôpital Louis Pradel (Pneumologie) | |
| Lyon, France | |
| 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 | |
| Paris - Saint Louis | |
| Paris, France, 75000 | |
| APHP - Hopital Tenon - Pneumologie | |
| Paris, France, 75020 | |
| 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 | |
| CHU Toulouse - Pneumologie | |
| Toulouse, France | |
| Clinique Pasteur | |
| 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 | |
| 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 |
| First Submitted: | October 17, 2008 |
| First Posted: | October 20, 2008 |
| Last Update Posted: | March 3, 2017 |
| Last Verified: | March 2017 |
Keywords provided by Intergroupe Francophone de Cancerologie Thoracique:
|
Chemotherapy, Adjuvant |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Carcinoma, Bronchogenic Bronchial Neoplasms Lung Neoplasms Respiratory Tract Neoplasms |
Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |