A Phase 2/3 interventional study of Standard Chemotherapy and Customized Treatment in Carcinoma, Non-Small-Cell Lung, sponsored by Intergroupe Francophone de Cancerologie Thoracique. Completed at 42 sites in France. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-03-03.
Sponsored by Intergroupe Francophone de Cancerologie Thoracique · Phase 2/3, Interventional, and Treatment
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.
6,485 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,630 are open to participants now.
This study's enrollment of 152 is above the median of 62 across 5,211 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Intergroupe Francophone de Cancerologie Thoracique is the lead sponsor of 57 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Standard chemotherapy
Drug: Standard Chemotherapy
Customized treatment
Drug: Customized Treatment
Pemetrexed Cisplatin Schedule : CDDP 75 mg/m² D1, pemetrexed 500 mg/m² D1 D1=D21, 4 cycles
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)
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
This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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Carcinoma, Non-Small-Cell Lung→
Intergroupe Francophone de Cancerologie Thoracique