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A Phase III Trial of Single Versus Fractionated Thoracic Radiation for Palliation of Symptoms in Patients With Non-Small Cell Lung Cancer (NCT00003685)

RATIONALE: Radiation therapy may relieve symptoms in patients with non-small cell lung cancer. It is not yet known which regimen of radiation therapy is most effective in relieving symptoms in patients with non-small cell lung cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of different regimens of radiation therapy to relieve symptoms in patients who have non-small cell lung cancer.
  • Procedure: fatigue assessment and management
    • Procedure: nausea and vomiting therapy
      • Procedure: pain therapy
        • Procedure: quality-of-life assessment
          • Radiation: radiation therapy
            Ages eligible for Study
            16 Years and older
            Genders eligible for Study
            All
            Accepts Healthy Volunteers
            No
            OBJECTIVES: I. Compare the efficacy of two schedules of radiotherapy in the palliation of symptoms in patients with non-small cell lung cancer. II. Compare the toxicity of these two regimens in these patients. III. Compare the quality of life and survival of patients treated with these two regimens.

            OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center, weight loss in the previous 6 months (no greater than 10% vs greater than 10%), and performance status (ECOG 0 or 1 vs 2 or 3). Patients are randomized to undergo radiotherapy as 5 fractions over 5 days or 1 fraction on 1 day. Quality of life is assessed before treatment, weekly for 5 weeks, and monthly thereafter. Patients are followed weekly for 5 weeks, then every 2 months for 1 year.

            PROJECTED ACCRUAL: A total of 210 patients will be accrued for this study.

            21 locations

            Canada (21)
            • Tom Baker Cancer Center - Calgary
              Calgary, Alberta, Canada, T2N 4N2
            • Cross Cancer Institute
              Edmonton, Alberta, Canada, T6G 1Z2
            • British Columbia Cancer Agency - Fraser Valley Cancer Centre
              Surrey, British Columbia, Canada, V3V 1Z2
            • BC Cancer Agency
              Vancouver, British Columbia, Canada, V5Z 4E6
            • British Columbia Cancer Agency - Vancouver Island Cancer Centre
              Victoria, British Columbia, Canada, V8R 1J8
            • CancerCare Manitoba
              Winnipeg, Manitoba, Canada, R3E 0V9
            • Doctor Leon Richard Oncology Centre
              Moncton, New Brunswick, Canada, E1C 8X3
            • Saint John Regional Hospital
              Saint John, New Brunswick, Canada, E2L 4L2
            • Dr. H. Bliss Murphy Cancer Centre
              St. Johns, Newfoundland and Labrador, Canada, A1B 3V6
            • Nova Scotia Cancer Centre
              Halifax, Nova Scotia, Canada, B3H 1V7
            • Cancer Care Ontario-Hamilton Regional Cancer Centre
              Hamilton, Ontario, Canada, L8V 5C2
            • Kingston Regional Cancer Centre
              Kingston, Ontario, Canada, K7L 5P9
            • Ottawa Regional Cancer Center - General Division
              Ottawa, Ontario, Canada, K1H 8L6
            • Ottawa Regional Cancer Centre - Civic Campus
              Ottawa, Ontario, Canada, K1Y 4K7
            • Peterborough Oncology Clinic
              Peterborough, Ontario, Canada, K9H 7B6
            • Hotel Dieu Hospital - St. Catharines
              St. Catharines, Ontario, Canada, L2R 5K3
            • Northeastern Ontario Regional Cancer Centre, Sudbury
              Sudbury, Ontario, Canada, P3E 5J1
            • Northwestern Ontario Regional Cancer Centre, Thunder Bay
              Thunder Bay, Ontario, Canada, P7A 7T1
            • Princess Margaret Hospital
              Toronto, Ontario, Canada, M5G 2M9
            • Cancer Care Ontario - Windsor Regional Cancer Centre
              Windsor, Ontario, Canada, N8W 2X3
            • Saskatoon Cancer Centre
              Saskatoon, Saskatchewan, Canada, S7N 4H4
            Status:
            completed
            Type:
            Interventional
            Phase:
            Start:
            30 November, 1998
            Updated:
            06 November, 2010
            Participants:
            210
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