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A Phase II Study of Accelerated Hypofractionated 3-Dimensional Conformal Radiotherapy (3DCRT) For Inoperable Stage I/II Non-Small Cell Lung Cancer (NSCLC)
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.
OBJECTIVES: Primary * Determine the local tumor control rate at 2 years after accelerated hypofractionated 3-dimensional, conformal radiotherapy in patients with inoperable T1-3 N0 M0 non-small cell lung cancer. Secondary * Determine the toxicities of this regimen in these patients. * Determine the rates of regional and distant disease recurrence in these patients. * Determine the progression-free and overall survival of patients treated with this regimen. * Determine the changes in pulmonary function after treatment in these patients. * Assess the quality of life of patients after treatment. 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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Tom Baker Cancer Centre
Calgary, Alberta, Canada
BCCA - Cancer Centre for the Southern Interior
Kelowna, British Columbia, Canada
BCCA - Fraser Valley Cancer Centre
Surrey, British Columbia, Canada
BCCA - Vancouver Cancer Centre
Vancouver, British Columbia, Canada
BCCA - Vancouver Island Cancer Centre
Victoria, British Columbia, Canada
CancerCare Manitoba
Winnipeg, Manitoba, Canada
Atlantic Health Sciences Corporation
Saint John, New Brunswick, Canada
Dr. H. Bliss Murphy Cancer Centre
St. John's, Newfoundland and Labrador, Canada
QEII Health Sciences Center
Halifax, Nova Scotia, Canada
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, Canada
Start Date
August 2, 2006
Primary Completion Date
February 28, 2012
Completion Date
August 20, 2014
Last Updated
August 4, 2023
80
ACTUAL participants
3-dimensional conformal radiation therapy
RADIATION
Lead Sponsor
NCIC Clinical Trials Group
NCT05692635
NCT06066138
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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