Chemoradiotherapy in Patients With Localised Lung Cancer

Sponsor
Trans Tasman Radiation Oncology Group
Study ID
NCT00193921
Phase
PHASE2
Status
Completed

Conditions

  • Non Small Cell Lung Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Vinorelbine — DRUG
    IV, 25mg/m2, days 1, 8, 22
  • High dose Radiotherapy — RADIATION
    External beam radiation, 40 Gy/20#/5 per week
  • Gemcitabine — DRUG
    200mg (flat dose) IV days 1, 8, 15
  • Cisplatin — DRUG
    20mg/m2, IV, weekly
  • High Dose Radiotherapy — RADIATION
    External beam radiation, 30 Gy/15#/5 per week

Study Details

The study compares 2 different methods of combined chemotherapy and radiotherapy for the treatment of localised lung cancer in patients not suitable for surgery. Hypothesis(es) to be tested: 1. Vinorelbine + cisplatin + high-dose palliative radiotherapy is superior to gemcitabine + high dose palliative radiotherapy in terms of efficacy in a multi-institutional setting 2. Vinorelbine + cisplatin + high-dose palliative radiotherapy is superior to gemcitabine + high dose palliative radiotherapy in terms of feasibility in a multi-institutional setting 3. Vinorelbine + cisplatin + high-dose palliative radiotherapy has a favourable toxicity profile relative to gemcitabine + high-dose palliative radiotherapy

Key Dates

Start date
Feb 28, 2003
Status verified
Jul 2014
Primary completion
Dec 31, 2009
Completion
Dec 31, 2012

Study Design

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

Arms

  • Experimental: A
    Vinorelbine + cisplatin + high-dose palliative radiotherapy
  • Active Comparator: B
    Gemcitabine + high-dose palliative radiotherapy

Primary Outcome Measure

Objective response rate (RECIST criteria) [ Time Frame: Final analysis will occur when all have a minimum 1 year follow-up after randomisation. Approx 3 years after start of trial. ]

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