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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

Phase 3
16 Years
Not Enrolling
Fatigue, Lung Cancer, Nausea and Vomiting, Pain, Pulmonary Complications, Quality of Life

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Trial Information

A Phase III Trial of Single Versus Fractionated Thoracic Radiation for Palliation of Symptoms in Patients With 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.

Inclusion 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

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

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Andrea Bezjak, MD, MSC, FRCPC

Investigator Role:

Study Chair

Investigator Affiliation:

Princess Margaret Hospital, Canada


United States: Federal Government

Study ID:




Start Date:

December 1998

Completion Date:

February 2009

Related Keywords:

  • Fatigue
  • Lung Cancer
  • Nausea and Vomiting
  • Pain
  • Pulmonary Complications
  • Quality of Life
  • stage III non-small cell lung cancer
  • recurrent non-small cell lung cancer
  • squamous cell lung cancer
  • large cell lung cancer
  • stage IV non-small cell lung cancer
  • adenocarcinoma of the lung
  • adenosquamous cell lung cancer
  • fatigue
  • nausea and vomiting
  • pain
  • pulmonary complications
  • quality of life
  • Carcinoma, Non-Small-Cell Lung
  • Fatigue
  • Lung Neoplasms
  • Nausea
  • Vomiting