Trial on Refinement of Early Stage Lung Cancer Adjuvant Therapy

Sponsor
Thoraxklinik-Heidelberg gGmbH
Study ID
NCT00349089
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 74 Years
Healthy Volunteers
Not accepted

Interventions

  • Pemetrexed — DRUG
    Pemetrexed 500 mg/m2 d1 and Cisplatin 75 mg/m2 d1; q d22
  • Cisplatin — DRUG
    Pemetrexed 500 mg/m2 d1 and Cisplatin 75 mg/m2 d1; q d22 Comparator: Vinorelbine 25 mg/m2 d1, 8, 15, 22; q d29 Cisplatin 50 mg/m2 d1, 8; q d29
  • Vinorelbine — DRUG
    Vinorelbine 25 mg/m2 d1, 8, 15, 22; q d29

Study Details

The purpose of this randomized phase II trial is to determine the clinical feasibility - in terms of patients without dose limiting toxicities or premature treatment withdrawal or death - of the combination of Cisplatin and Pemetrexed and of the combination of Cisplatin and Vinorelbine. The combination of Cisplatin / Pemetrexed is assumed to be distinctly less toxic than Vinorelbine / Cisplatin.

Key Dates

Start date
Sep 26, 2006
Status verified
Sep 2019
Primary completion
Apr 14, 2014
Completion
Apr 14, 2014

Study Design

Enrollment
132 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: 1
    Cisplatin/Vinorelbine
  • Experimental: 2
    Cisplatin/Pemetrexed

Primary Outcome Measure

To determine the clinical feasibility rate of 4 cycles of adjuvant chemotherapy with Pemetrexed and Cisplatin vs. Vinorelbine and Cisplatin [ Time Frame: 4 month ]

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