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

Phase 3

Completed

• Conditions: Pulmonary Complications; Nausea and Vomiting; Quality of Life; Fatigue; Lung Cancer; Pain

• Registration Number: NCT00003685
• Lead Sponsor: NCIC Clinical Trials Group

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 1997-08-01
• Study First Submitted: 1999-11-01
• Primary Completion: 2001-03
• Study First Submitted QC: 2004-05-19
• Study First Posted: 2004-05-20
• Study Completion: 2009-02-10
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-01
• Last Update Posted: 2020-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 230

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (21)

Tom Baker Cancer Center - Calgary; 🇨🇦 Calgary, Alberta, Canada

Cross Cancer Institute; 🇨🇦 Edmonton, Alberta, Canada

British Columbia Cancer Agency - Vancouver Island Cancer Centre; 🇨🇦 Victoria, British Columbia, Canada

Dr. H. Bliss Murphy Cancer Centre; 🇨🇦 St. Johns, Newfoundland and Labrador, Canada

Nova Scotia Cancer Centre; 🇨🇦 Halifax, Nova Scotia, Canada

Saint John Regional Hospital; 🇨🇦 Saint John, New Brunswick, Canada

Doctor Leon Richard Oncology Centre; 🇨🇦 Moncton, New Brunswick, Canada

CancerCare Manitoba; 🇨🇦 Winnipeg, Manitoba, Canada

British Columbia Cancer Agency - Fraser Valley Cancer Centre; 🇨🇦 Surrey, British Columbia, Canada

BC Cancer Agency; 🇨🇦 Vancouver, British Columbia, Canada

Ottawa Regional Cancer Centre - Civic Campus; 🇨🇦 Ottawa, Ontario, Canada

Peterborough Oncology Clinic; 🇨🇦 Peterborough, Ontario, Canada

Saskatoon Cancer Centre; 🇨🇦 Saskatoon, Saskatchewan, Canada

Cancer Care Ontario-Hamilton Regional Cancer Centre; 🇨🇦 Hamilton, Ontario, Canada

Princess Margaret Hospital; 🇨🇦 Toronto, Ontario, Canada

Cancer Care Ontario - Windsor Regional Cancer Centre; 🇨🇦 Windsor, Ontario, Canada

Kingston Regional Cancer Centre; 🇨🇦 Kingston, Ontario, Canada

Hotel Dieu Hospital - St. Catharines; 🇨🇦 St. Catharines, Ontario, Canada

Ottawa Regional Cancer Center - General Division; 🇨🇦 Ottawa, Ontario, Canada

Northwestern Ontario Regional Cancer Centre, Thunder Bay; 🇨🇦 Thunder Bay, Ontario, Canada

Northeastern Ontario Regional Cancer Centre, Sudbury; 🇨🇦 Sudbury, Ontario, Canada