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

NCT ID: NCT00003685

Last Updated: 2020-04-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 230 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1997-08-01
• Study Completion Date: 2009-02-10

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

fatigue assessment and management

Intervention Type: PROCEDURE

nausea and vomiting therapy

Intervention Type: PROCEDURE

pain therapy

Intervention Type: PROCEDURE

quality-of-life assessment

Intervention Type: PROCEDURE

radiation therapy

Intervention Type: RADIATION

Eligibility Criteria

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 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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NCIC Clinical Trials Group

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrea Bezjak, MD, MSC, FRCPC

Role: STUDY_CHAIR

Princess Margaret Hospital, Canada

Locations

Tom Baker Cancer Center - Calgary

Calgary, Alberta, Canada

Cross Cancer Institute

Edmonton, Alberta, Canada

British Columbia Cancer Agency - Fraser Valley Cancer Centre

Surrey, British Columbia, Canada

BC Cancer Agency

Vancouver, British Columbia, Canada

British Columbia Cancer Agency - Vancouver Island Cancer Centre

Victoria, British Columbia, Canada

CancerCare Manitoba

Winnipeg, Manitoba, Canada

Doctor Leon Richard Oncology Centre

Moncton, New Brunswick, Canada

Saint John Regional Hospital

Saint John, New Brunswick, Canada

Dr. H. Bliss Murphy Cancer Centre

St. John's, Newfoundland and Labrador, Canada

Nova Scotia Cancer Centre

Halifax, Nova Scotia, Canada

Northeastern Ontario Regional Cancer Centre, Sudbury

Greater Sudbury, Ontario, Canada

Cancer Care Ontario-Hamilton Regional Cancer Centre

Hamilton, Ontario, Canada

Kingston Regional Cancer Centre

Kingston, Ontario, Canada

Ottawa Regional Cancer Center - General Division

Ottawa, Ontario, Canada

Ottawa Regional Cancer Centre - Civic Campus

Ottawa, Ontario, Canada

Peterborough Oncology Clinic

Peterborough, Ontario, Canada

Hotel Dieu Hospital - St. Catharines

St. Catharines, Ontario, Canada

Northwestern Ontario Regional Cancer Centre, Thunder Bay

Thunder Bay, Ontario, Canada

Princess Margaret Hospital

Toronto, Ontario, Canada

Cancer Care Ontario - Windsor Regional Cancer Centre

Windsor, Ontario, Canada

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, Canada

Countries

Canada

References

Bezjak A, Dixon P, Brundage M, Tu D, Palmer MJ, Blood P, Grafton C, Lochrin C, Leong C, Mulroy L, Smith C, Wright J, Pater JL; Clinical Trials Group of the National Cancer Institute of Canada. Randomized phase III trial of single versus fractionated thoracic radiation in the palliation of patients with lung cancer (NCIC CTG SC.15). Int J Radiat Oncol Biol Phys. 2002 Nov 1;54(3):719-28. doi: 10.1016/s0360-3016(02)02989-9.

Reference Type: RESULT

PMID: 12377323 (View on PubMed)

Other Identifiers

CAN-NCIC-SC15

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000066787

Identifier Type: OTHER

Identifier Source: secondary_id

SC15

Identifier Type: -

Identifier Source: org_study_id