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

Sponsor

NCIC Clinical Trials Group (Other)

Overall Status

Completed

CT.gov ID

NCT00003685

Collaborator

(none)

230

Enrollment

Locations

138.3

Actual Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Fatigue Lung Cancer Nausea and Vomiting Pain Pulmonary Complications Quality of Life	Procedure: fatigue assessment and management Procedure: nausea and vomiting therapy Procedure: pain therapy Procedure: quality-of-life assessment Radiation: radiation therapy	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

230 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase III Trial of Single Versus Fractionated Thoracic Radiation for Palliation of Symptoms in Patients With Non-Small Cell Lung Cancer

Actual Study Start Date :

Aug 1, 1997

Actual Primary Completion Date :

Mar 1, 2001

Actual Study Completion Date :

Feb 10, 2009

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 120 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tom Baker Cancer Center - Calgary	Calgary	Alberta	Canada	T2N 4N2
2	Cross Cancer Institute	Edmonton	Alberta	Canada	T6G 1Z2
3	British Columbia Cancer Agency - Fraser Valley Cancer Centre	Surrey	British Columbia	Canada	V3V 1Z2
4	BC Cancer Agency	Vancouver	British Columbia	Canada	V5Z 4E6
5	British Columbia Cancer Agency - Vancouver Island Cancer Centre	Victoria	British Columbia	Canada	V8R 1J8
6	CancerCare Manitoba	Winnipeg	Manitoba	Canada	R3E 0V9
7	Doctor Leon Richard Oncology Centre	Moncton	New Brunswick	Canada	E1C 8X3
8	Saint John Regional Hospital	Saint John	New Brunswick	Canada	E2L 4L2
9	Dr. H. Bliss Murphy Cancer Centre	St. Johns	Newfoundland and Labrador	Canada	A1B 3V6
10	Nova Scotia Cancer Centre	Halifax	Nova Scotia	Canada	B3H 1V7
11	Cancer Care Ontario-Hamilton Regional Cancer Centre	Hamilton	Ontario	Canada	L8V 5C2
12	Kingston Regional Cancer Centre	Kingston	Ontario	Canada	K7L 5P9
13	Ottawa Regional Cancer Center - General Division	Ottawa	Ontario	Canada	K1H 8L6
14	Ottawa Regional Cancer Centre - Civic Campus	Ottawa	Ontario	Canada	K1Y 4K7
15	Peterborough Oncology Clinic	Peterborough	Ontario	Canada	K9H 7B6
16	Hotel Dieu Hospital - St. Catharines	St. Catharines	Ontario	Canada	L2R 5K3
17	Northeastern Ontario Regional Cancer Centre, Sudbury	Sudbury	Ontario	Canada	P3E 5J1
18	Northwestern Ontario Regional Cancer Centre, Thunder Bay	Thunder Bay	Ontario	Canada	P7A 7T1
19	Princess Margaret Hospital	Toronto	Ontario	Canada	M5G 2M9
20	Cancer Care Ontario - Windsor Regional Cancer Centre	Windsor	Ontario	Canada	N8W 2X3
21	Saskatoon Cancer Centre	Saskatoon	Saskatchewan	Canada	S7N 4H4