Clinical trial NCT00775385: TAilored Post-Surgical Therapy in Early Stage NSCLC
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).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: Chemotherapy, Adjuvant
Lead sponsor: Intergroupe Francophone de Cancerologie Thoracique
Sponsor class: OTHER
First posted: 2008-10-20
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Feasibility (% of patients having started the treatment before 2 months after the surgery, with the biological results EGFR and ERCC1)
timeFrame: week
Secondary outcomes:
measure: Disease-free Survival
timeFrame: month
Other outcomes:
Locations:
city: Aix en Provence
country: France
facility: Centre Hospitalier
city: Amiens
country: France
facility: Clinique de L'Europe
city: Angers
country: France
facility: Angers - CHU
city: Béziers
country: France
facility: Centre Hospitalier
city: Caen
country: France
facility: Centre F. Baclesse
city: Caen
country: France
facility: CHU - Pneumologie
city: Chauny
country: France
facility: Centre Hospitalier
city: Chevilly Larue
country: France
facility: Chevilly Larue - CH
city: Clamart
country: France
facility: Hôpital Percy-Armées - Pneumologie
city: Clermont Ferrand
country: France
facility: Clermont Ferrand - CHU
city: Colmar
country: France
facility: Colmar - CH
city: Dax
country: France
facility: Dax - CH
city: Ermont
country: France
facility: Ermont - Clinique Claude Bernard
city: Grenoble
country: France
facility: CHU Grenoble - pneumologie
city: Le Mans
country: France
facility: Le Mans - CHG
city: Lyon
country: France
facility: Centre Léon Bérard
city: Lyon
country: France
facility: Lyon - Hôpital Louis Pradel (Pneumologie)
city: Mantes La Jolie
country: France
facility: Mantes La Jolie - CH
city: Marseille
country: France
facility: APHM - Hôpital Sainte Marguerite
city: Marseille
country: France
facility: Institut Paoli Calmette
city: Metz
country: France
facility: Metz - Belle Isle
city: Mont de Marsan
country: France
facility: Mont de Marsan - CH
city: Montpellier
country: France
facility: Montpellier - Clinique Clémentville
city: Mulhouse
country: France
facility: Mulhouse - CH
city: Nancy
country: France
facility: Nancy - Polyclinique Gentilly
city: Nevers
country: France
facility: Nevers - CH
city: Paris
country: France
facility: Paris - Saint Louis
city: Paris
country: France
facility: APHP - Hopital Tenon - Pneumologie
city: Pau
country: France
facility: Pau - CH
city: Pierre Bénite
country: France
facility: HCL - Lyon Sud (Pneumologie)
city: Reims
country: France
facility: Reims - CHU
city: Rennes
country: France
facility: Rennes - CHU
city: Saint-Quentin
country: France
facility: Centre Hospitalier
city: Strasbourg
country: France
facility: Nouvel Hopital Civil
city: Suresnes
country: France
facility: Hôpital Foch
city: Toulon
country: France
facility: Centre Hospitalier Intercommunal
city: Toulouse
country: France
facility: CHU Toulouse - Pneumologie
city: Toulouse
country: France
facility: Clinique Pasteur
city: Tours
country: France
facility: Tours - CHU
city: Vandoeuvre lès Nancy
country: France
facility: Nancy - CHU
city: Villejuif
country: France
facility: Institut Gustave Roussy
city: Villeneuve-Saint-Georges
country: France
facility: Centre Hospitalier Intercommunal
Study officials:
affiliation: Institut Gustave Roussy (IGR)
name: Jean-Charles SORIA, Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: APHP - Hôpital Tenon (Paris)
name: Marie Wislez, Pr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wislez M, Barlesi F, Besse B, Mazieres J, Merle P, Cadranel J, Audigier-Valette C, Moro-Sibilot D, Gautier-Felizot L, Goupil F, Renault A, Quoix E, Souquet PJ, Madroszyck A, Corre R, Perol D, Morin F, Zalcman G, Soria JC. Customized adjuvant phase II trial in patients with non-small-cell lung cancer: IFCT-0801 TASTE. J Clin Oncol. 2014 Apr 20;32(12):1256-61. doi: 10.1200/JCO.2013.53.1525. Epub 2014 Mar 17.