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

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ClinicalTrials.gov Identifier: NCT00775385
Recruitment Status : Completed
First Posted : October 20, 2008
Last Update Posted : March 3, 2017
Sponsor:
Information provided by (Responsible Party):
Intergroupe Francophone de Cancerologie Thoracique

Tracking Information
First Submitted Date  ICMJE October 17, 2008
First Posted Date  ICMJE October 20, 2008
Last Update Posted Date March 3, 2017
Study Start Date  ICMJE April 2009
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 23, 2009)
Feasibility (% of patients having started the treatment before 2 months after the surgery, with the biological results EGFR and ERCC1) [ Time Frame: week ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 17, 2008)
Feasibility (% of patients having completed 4 cycles of chemotherapy or 9 weeks of erlotinib at any dose) [ Time Frame: week ]
Change History Complete list of historical versions of study NCT00775385 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 17, 2008)
Disease-free Survival [ Time Frame: month ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE TAilored Post-Surgical Therapy in Early Stage NSCLC
Official Title  ICMJE 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).
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Carcinoma, Non-Small-Cell Lung
Intervention  ICMJE
  • 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)
Study Arms  ICMJE
  • Active Comparator: A
    Standard chemotherapy
    Intervention: Drug: Standard Chemotherapy
  • Experimental: B
    Customized treatment
    Intervention: Drug: Customized Treatment
Publications * Wislez M, Barlesi F, Besse B, Mazières 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, Pérol 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 24, 2013)
152
Original Estimated Enrollment  ICMJE
 (submitted: October 17, 2008)
108
Actual Study Completion Date  ICMJE January 21, 2016
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00775385
Other Study ID Numbers  ICMJE IFCT-0801
Eudract : 2008-004939-38
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Intergroupe Francophone de Cancerologie Thoracique
Study Sponsor  ICMJE Intergroupe Francophone de Cancerologie Thoracique
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jean-Charles SORIA, Pr Institut Gustave Roussy (IGR)
Principal Investigator: Marie Wislez, Pr APHP - Hôpital Tenon (Paris)
PRS Account Intergroupe Francophone de Cancerologie Thoracique
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP