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Clinical Trials/EUCTR2008-000570-21-IT
EUCTR2008-000570-21-IT
Active, not recruiting
Not Applicable

Randomized phase II study of adjuvant chemotherapy with cisplatin + vinorelbine vs gemcitabine + vinorelbine in stage IB-IIIA radically resected non-small cell lung cancer (NSCLC) patients - MADS

IST - ISTITUTO NAZIONALE PER LA RICERCA SUL CANCRO0 sitesNovember 7, 2008

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
non-small cell lung cancer (NSCLC)
Sponsor
IST - ISTITUTO NAZIONALE PER LA RICERCA SUL CANCRO
Status
Active, not recruiting
Last Updated
14 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
November 7, 2008
End Date
TBD
Last Updated
14 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
IST - ISTITUTO NAZIONALE PER LA RICERCA SUL CANCRO

Eligibility Criteria

Inclusion Criteria

  • 1\.Written informed consent
  • 2\.Age \> 18 years.
  • 3\.ECOG Performance status \< 1
  • 4\.No evidence of important comorbidity
  • 5\.Radical resection (R0\)
  • 6\.Pathological stage IB\-IIA, IIIA (T3N1 only)
  • 7\.Histological diagnosis of non\-small cell lung cancer (NSCLC)
  • 8\.No prior chemotherapy for NSCLC
  • 9\.Geographic proximity for an adequate follow\-up
  • 10\.Baseline hematological examination assessed within 15 days prior to the enrollement, with the following values:

Exclusion Criteria

  • patient refusal
  • treatment not in the best interest of the patient, according to the responsible physician
  • excessive toxicity precluding further therapy, according to the responsible physician
  • treatment delay of more than 2 weeks
  • tumor progression
  • prior chemotherapy

Outcomes

Primary Outcomes

Not specified

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