Clinical trial NCT00003685: Radiation Therapy to Relieve Symptoms in Patients With Non-small Cell Lung Cancer
Official title: A Phase III Trial of Single Versus Fractionated Thoracic Radiation for Palliation of Symptoms in Patients With Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Fatigue
Lung Cancer
Nausea and Vomiting
Pain
Pulmonary Complications
Quality of Life
Keywords: 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
Lead sponsor: Canadian Cancer Trials Group
Sponsor class: NETWORK
First posted: 2004-05-20
Enrollment: 230
Sex: ALL
Minimum age (years): 16
Maximum age (years): 120
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Tom Baker Cancer Center - Calgary
state: Alberta
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Surrey
country: Canada
facility: British Columbia Cancer Agency - Fraser Valley Cancer Centre
state: British Columbia
city: Vancouver
country: Canada
facility: BC Cancer Agency
state: British Columbia
city: Victoria
country: Canada
facility: British Columbia Cancer Agency - Vancouver Island Cancer Centre
state: British Columbia
city: Winnipeg
country: Canada
facility: CancerCare Manitoba
state: Manitoba
city: Moncton
country: Canada
facility: Doctor Leon Richard Oncology Centre
state: New Brunswick
city: Saint John
country: Canada
facility: Saint John Regional Hospital
state: New Brunswick
city: St. Johns
country: Canada
facility: Dr. H. Bliss Murphy Cancer Centre
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: Nova Scotia Cancer Centre
state: Nova Scotia
city: Hamilton
country: Canada
facility: Cancer Care Ontario-Hamilton Regional Cancer Centre
state: Ontario
city: Kingston
country: Canada
facility: Kingston Regional Cancer Centre
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Regional Cancer Center - General Division
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Regional Cancer Centre - Civic Campus
state: Ontario
city: Peterborough
country: Canada
facility: Peterborough Oncology Clinic
state: Ontario
city: St. Catharines
country: Canada
facility: Hotel Dieu Hospital - St. Catharines
state: Ontario
city: Sudbury
country: Canada
facility: Northeastern Ontario Regional Cancer Centre, Sudbury
state: Ontario
city: Thunder Bay
country: Canada
facility: Northwestern Ontario Regional Cancer Centre, Thunder Bay
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
city: Windsor
country: Canada
facility: Cancer Care Ontario - Windsor Regional Cancer Centre
state: Ontario
city: Saskatoon
country: Canada
facility: Saskatoon Cancer Centre
state: Saskatchewan
Study officials:
affiliation: Princess Margaret Hospital, Canada
name: Andrea Bezjak, MD, MSC, FRCPC
role: STUDY_CHAIR
References:
citation: 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.