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TAilored Post-Surgical Therapy in Early Stage NSCLC (TASTE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00775385
Recruitment Status : Completed
First Posted : October 20, 2008
Last Update Posted : March 3, 2017
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Drug: Standard Chemotherapy Drug: Customized Treatment Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 152 participants
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).
Study Start Date : April 2009
Actual Primary Completion Date : April 2013
Actual Study Completion Date : January 21, 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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 :

  • ERCC1 high : no treatment
  • ERCC1 low or undetermined : Pemetrexed Cisplatin, 4 cycles (63 days)

Primary Outcome Measures :
  1. Feasibility (% of patients having started the treatment before 2 months after the surgery, with the biological results EGFR and ERCC1) [ Time Frame: week ]

Secondary Outcome Measures :
  1. Disease-free Survival [ Time Frame: month ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00775385

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Sponsors and Collaborators
Intergroupe Francophone de Cancerologie Thoracique
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Principal Investigator: Jean-Charles SORIA, Pr Institut Gustave Roussy (IGR)
Principal Investigator: Marie Wislez, Pr APHP - Hôpital Tenon (Paris)
Additional Information:
Publications of Results:
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Responsible Party: Intergroupe Francophone de Cancerologie Thoracique Identifier: NCT00775385    
Other Study ID Numbers: IFCT-0801
Eudract : 2008-004939-38
First Posted: October 20, 2008    Key Record Dates
Last Update Posted: March 3, 2017
Last Verified: March 2017
Keywords provided by Intergroupe Francophone de Cancerologie Thoracique:
Chemotherapy, Adjuvant
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases