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

Last updated: April 1, 2020
Sponsor: NCIC Clinical Trials Group
Overall Status: Completed

Phase

3

Condition

Lung Disease

Stomach Discomfort

Lung Cancer

Treatment

N/A

Clinical Study ID

NCT00003685
SC15
CDR0000066787
CAN-NCIC-SC15
  • Ages 16-120
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Study Design

Total Participants: 230
Study Start date:
August 01, 1997
Estimated Completion Date:
February 10, 2009

Study 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.

Connect with a study center

  • Tom Baker Cancer Center - Calgary

    Calgary, Alberta T2N 4N2
    Canada

    Site Not Available

  • Cross Cancer Institute

    Edmonton, Alberta T6G 1Z2
    Canada

    Site Not Available

  • British Columbia Cancer Agency - Fraser Valley Cancer Centre

    Surrey, British Columbia V3V 1Z2
    Canada

    Site Not Available

  • BC Cancer Agency

    Vancouver, British Columbia V5Z 4E6
    Canada

    Site Not Available

  • British Columbia Cancer Agency - Vancouver Island Cancer Centre

    Victoria, British Columbia V8R 1J8
    Canada

    Site Not Available

  • CancerCare Manitoba

    Winnipeg, Manitoba R3E 0V9
    Canada

    Site Not Available

  • Doctor Leon Richard Oncology Centre

    Moncton, New Brunswick E1C 8X3
    Canada

    Site Not Available

  • Saint John Regional Hospital

    Saint John, New Brunswick E2L 4L2
    Canada

    Site Not Available

  • Dr. H. Bliss Murphy Cancer Centre

    St. Johns, Newfoundland and Labrador A1B 3V6
    Canada

    Site Not Available

  • Nova Scotia Cancer Centre

    Halifax, Nova Scotia B3H 1V7
    Canada

    Site Not Available

  • Cancer Care Ontario-Hamilton Regional Cancer Centre

    Hamilton, Ontario L8V 5C2
    Canada

    Site Not Available

  • Kingston Regional Cancer Centre

    Kingston, Ontario K7L 5P9
    Canada

    Site Not Available

  • Ottawa Regional Cancer Center - General Division

    Ottawa, Ontario K1H 8L6
    Canada

    Site Not Available

  • Ottawa Regional Cancer Centre - Civic Campus

    Ottawa, Ontario K1Y 4K7
    Canada

    Site Not Available

  • Peterborough Oncology Clinic

    Peterborough, Ontario K9H 7B6
    Canada

    Site Not Available

  • Hotel Dieu Hospital - St. Catharines

    St. Catharines, Ontario L2R 5K3
    Canada

    Site Not Available

  • Northeastern Ontario Regional Cancer Centre, Sudbury

    Sudbury, Ontario P3E 5J1
    Canada

    Site Not Available

  • Northwestern Ontario Regional Cancer Centre, Thunder Bay

    Thunder Bay, Ontario P7A 7T1
    Canada

    Site Not Available

  • Princess Margaret Hospital

    Toronto, Ontario M5G 2M9
    Canada

    Site Not Available

  • Cancer Care Ontario - Windsor Regional Cancer Centre

    Windsor, Ontario N8W 2X3
    Canada

    Site Not Available

  • Saskatoon Cancer Centre

    Saskatoon, Saskatchewan S7N 4H4
    Canada

    Site Not Available

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