TAilored Post-Surgical Therapy in Early Stage NSCLC

Phase 2

Completed

• Conditions: Carcinoma, Non-Small-Cell Lung
• Interventions: Drug: Standard Chemotherapy; Drug: Customized Treatment

• Registration Number: NCT00775385
• Lead Sponsor: Intergroupe Francophone de Cancerologie Thoracique

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-10-17
• Study First Submitted QC: 2008-10-17
• Study First Posted: 2008-10-20
• Study Start: 2009-04
• Primary Completion: 2013-04
• Study Completion: 2016-01-21
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-01
• Last Update Posted: 2017-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 152

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Standard Chemotherapy	Standard chemotherapy
B	Customized Treatment	Customized treatment

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Disease-free Survival	month

Trial Locations

Locations (38)

Centre Hospitalier; 🇫🇷 Saint-Quentin, France

Clinique de L'Europe; 🇫🇷 Amiens, France

Angers - CHU; 🇫🇷 Angers, France

Centre F. Baclesse; 🇫🇷 Caen, France

CHU - Pneumologie; 🇫🇷 Caen, France

Chevilly Larue - CH; 🇫🇷 Chevilly Larue, France

Hôpital Percy-Armées - Pneumologie; 🇫🇷 Clamart, France

Clermont Ferrand - CHU; 🇫🇷 Clermont Ferrand, France

Colmar - CH; 🇫🇷 Colmar, France

Dax - CH; 🇫🇷 Dax, France

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