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.

Condition	Treatment or Intervention	Phase
Pain stage IV non-small cell lung cancer Adenosquamous Cell Lung Cancer Squamous Cell Lung Cancer Pulmonary Complications recurrent non-small cell lung cancer stage III non-small cell lung cancer Adenocarcinoma of the Lung Fatigue Quality of Life large cell lung cancer nausea and vomiting	Procedure: Radiotherapy for lung cancer	Phase III

Further Study Details: 

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.

PROTOCOL 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.

Ages Eligible for Study:  16 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically or cytologically proven non-small cell lung cancer; Squamous cell lung cancer; Large cell lung cancer; Adenocarcinoma lung cancer Mixture of above Locally advanced disease for which the patient declined aggressive treatment or that is unsuitable for aggressive curative treatment due to at least one of the following: Performance status of ECOG 2 or 3 Otherwise unexplained weight loss greater than 10% in the last 6 months Bulky disease that cannot be irradiated safely to high doses; Inability to tolerate chemotherapy; Cytologically positive pleural effusion OR
• Clinically or radiologically proven metastatic disease for which palliative chemotherapy is not planned in the first 38 days after radiotherapy; No more than one brain metastasis allowed
• One of the following symptoms identified as the index symptom: Loss of appetite; Nausea; Vomiting; Cough; Coughing up blood; Chest pain; Shortness of breath; Difficulty swallowing; Fatigue
• Must have symptoms related to intrathoracic lung cancer that are amenable to radiation palliation

--Prior/Concurrent Therapy--

• Biologic therapy: Not specified
• Chemotherapy: At least 30 days since prior chemotherapy and failed; No planned chemotherapy within 38 days after study treatment
• Endocrine therapy: Not specified
• Radiotherapy: No planned laser therapy within 38 days after study treatment
• Surgery: At least 30 days since prior surgery and failed
• Other: No planned photodynamic therapy or sclerotherapy within 38 days after study treatment

--Patient Characteristics--

• Age: 16 and over
• Performance status: ECOG 0-3
• Life expectancy: Greater than 3 months
• Hematopoietic: Not specified
• Hepatic: Not specified
• Renal: Not specified
• Other: Fluent in English or French; No loss of sight or other inability to complete questionnaires or diary; Not pregnant; No concurrent terminal illness; No other active malignancy that is causing symptoms or is expected to progress in the next 3 months

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

Study chairs or principal investigators

Andrea Bezjak,  Study Chair,  National Cancer Institute of Canada   

Study ID Numbers:  CDR0000066787; CAN-NCIC-SC15
Record last reviewed:  May 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003685
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08