Radiation Therapy to Relieve Symptoms in Patients With Non-small Cell Lung Cancer
Radiation Therapy to Relieve Symptoms in Patients With Non-small Cell Lung Cancer
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.
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.
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

 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

 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