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TAilored Post-Surgical Therapy in Early Stage NSCLC

NCT00775385 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 152

Last updated 2017-03-03

No results posted yet for this study

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.

Conditions

  • Carcinoma, Non-Small-Cell Lung

Interventions

DRUG

Standard Chemotherapy

Pemetrexed Cisplatin Schedule : CDDP 75 mg/m² D1, pemetrexed 500 mg/m² D1 D1=D21, 4 cycles

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)

Sponsors & Collaborators

  • Intergroupe Francophone de Cancerologie Thoracique

    lead OTHER

Principal Investigators

  • Jean-Charles SORIA, Pr · Institut Gustave Roussy (IGR)

  • Marie Wislez, Pr · APHP - Hôpital Tenon (Paris)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2013-04-30
Completion
2016-01-21

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00775385 on ClinicalTrials.gov