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Sponsored by: |
National Cancer Institute of Canada |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00346320 |
RATIONALE: Radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.
PURPOSE: This phase II trial is studying how well radiation therapy works in treating patients with stage I or stage II non-small cell lung cancer that cannot be removed by surgery.
Condition | Intervention | Phase |
---|---|---|
Lung Cancer |
Radiation: 3-dimensional conformal radiation therapy Radiation: hypofractionated radiation therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase II Study of Accelerated Hypofractionated 3-Dimensional Conformal Radiotherapy (3DCRT) For Inoperable Stage I/II Non-Small Cell Lung Cancer (NSCLC) |
Estimated Enrollment: | 80 |
Study Start Date: | April 2006 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter, prospective study.
Patients undergo accelerated hypofractionated conformal radiotherapy 5 days a week for up to 3 weeks (15 doses) in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, at week 3 of radiotherapy, at 1 month after completion of radiotherapy, and then every 4 months for 1 year.
After completion of study treatment, patients are followed periodically for 5 years.
PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
Stage I or II peripheral disease
Any of the following primary cancer types:
Cytologic specimens obtained by brushing, washing, or needle aspiration of defined lesion allowed
PATIENT CHARACTERISTICS:
No previous malignancy except adequately treated nonmelanomatous skin cancer or carcinoma in situ
PRIOR CONCURRENT THERAPY:
Canada, Alberta | |
Cross Cancer Institute at University of Alberta | |
Edmonton, Alberta, Canada, T6G 1Z2 | |
Tom Baker Cancer Centre - Calgary | |
Calgary, Alberta, Canada, T2N 4N2 | |
Canada, British Columbia | |
BCCA - Fraser Valley Cancer Centre | |
Surrey, British Columbia, Canada, V3V 1Z2 | |
British Columbia Cancer Agency - Centre for the Southern Interior | |
Kelowna, British Columbia, Canada, V1Y 5L3 | |
British Columbia Cancer Agency - Vancouver Cancer Centre | |
Vancouver, British Columbia, Canada, V5Z 4E6 | |
British Columbia Cancer Agency - Vancouver Island Centre | |
Victoria, British Columbia, Canada, V8R 6V5 | |
Canada, Manitoba | |
CancerCare Manitoba | |
Winnipeg, Manitoba, Canada, R3E 0V9 | |
Canada, New Brunswick | |
Saint John Regional Hospital | |
Saint John, New Brunswick, Canada, E2L 4L2 | |
Canada, Newfoundland and Labrador | |
Doctor H. Bliss Murphy Cancer Centre | |
St. John's, Newfoundland and Labrador, Canada, AIB 3V6 | |
Canada, Nova Scotia | |
Nova Scotia Cancer Centre | |
Halifax, Nova Scotia, Canada, B3H 1V7 | |
Canada, Ontario | |
Cancer Care Program at Thunder Bay Regional Health Sciences | |
Thunder Bay, Ontario, Canada, P7B 6V4 | |
Cancer Centre of Southeastern Ontario at Kingston General Hospital | |
Kingston, Ontario, Canada, K7L 5P9 | |
Edmond Odette Cancer Centre at Sunnybrook | |
Toronto, Ontario, Canada, M4N 3M5 | |
London Regional Cancer Program at London Health Sciences Centre | |
London, Ontario, Canada, N6A 4L6 | |
Margaret and Charles Juravinski Cancer Centre | |
Hamilton, Ontario, Canada, L8V 5C2 | |
R. S. McLaughlin Durham Regional Cancer Centre at Lakeridge Health Oshawa | |
Oshawa, Ontario, Canada, L1G 2B9 | |
Canada, Quebec | |
Centre Hospitalier Universitaire de Quebec | |
Quebec City, Quebec, Canada, G1R 2J6 | |
Hopital Notre-Dame du CHUM | |
Montreal, Quebec, Canada, H2L 4M1 | |
Maisonneuve-Rosemont Hospital | |
Montreal, Quebec, Canada, H1T 2M4 | |
McGill Cancer Centre at McGill University | |
Montreal, Quebec, Canada, H2W 1S6 |
Study Chair: | Patrick C. F. Cheung, MD, FRCPC | Edmond Odette Cancer Centre at Sunnybrook |
Investigator: | Sergio L. Faria, MD, PhD | Montreal General Hospital |
Study ID Numbers: | CDR0000486919, CAN-NCIC-BR25 |
Study First Received: | June 28, 2006 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00346320 History of Changes |
Health Authority: | United States: Federal Government |
stage I non-small cell lung cancer stage II non-small cell lung cancer adenocarcinoma of the lung adenosquamous cell lung cancer |
bronchoalveolar cell lung cancer large cell lung cancer squamous cell lung cancer |
Thoracic Neoplasms Respiratory Tract Diseases Adenocarcinoma, Bronchiolo-Alveolar Lung Neoplasms Lung Diseases Non-small Cell Lung Cancer |
Adenocarcinoma of Lung Adenocarcinoma Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms Neoplasms by Site Neoplasms by Histologic Type Respiratory Tract Diseases |
Lung Neoplasms Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |