Radiation in Stage I or Stage II Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery
- Conditions
- Lung Cancer
- Interventions
- Radiation: 3-dimensional conformal radiation therapy
- Registration Number
- NCT00346320
- Lead Sponsor
- NCIC Clinical Trials Group
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Radiotherapy 3-dimensional conformal radiation therapy 3-dimensional conformal radiotherapy, 60 Gy in once daily 4 Gy fractions (Monday to Friday) over 3 weeks
- Primary Outcome Measures
Name Time Method Local tumor control rate at 2 years 2 years Overall tumor control rate will be assessed at 6 years
- Secondary Outcome Measures
Name Time Method Toxicity 6 years Disease recurrence rates 6 years Progression-free survival 6 years Overall survival 6 years Quality of life 6 years Changes in pulmonary function 6 years
Trial Locations
- Locations (19)
Tom Baker Cancer Centre
🇨🇦Calgary, Alberta, Canada
BCCA - Fraser Valley Cancer Centre
🇨🇦Surrey, British Columbia, Canada
BCCA - Vancouver Island Cancer Centre
🇨🇦Victoria, British Columbia, Canada
CancerCare Manitoba
🇨🇦Winnipeg, Manitoba, Canada
BCCA - Cancer Centre for the Southern Interior
🇨🇦Kelowna, British Columbia, Canada
BCCA - Vancouver Cancer Centre
🇨🇦Vancouver, British Columbia, Canada
Atlantic Health Sciences Corporation
🇨🇦Saint John, New Brunswick, Canada
QEII Health Sciences Center
🇨🇦Halifax, Nova Scotia, Canada
Dr. H. Bliss Murphy Cancer Centre
🇨🇦St. John's, Newfoundland and Labrador, Canada
Juravinski Cancer Centre at Hamilton Health Sciences
🇨🇦Hamilton, Ontario, Canada
London Regional Cancer Program
🇨🇦London, Ontario, Canada
Odette Cancer Centre
🇨🇦Toronto, Ontario, Canada
Lakeridge Health Oshawa
🇨🇦Oshawa, Ontario, Canada
Thunder Bay Regional Health Science Centre
🇨🇦Thunder Bay, Ontario, Canada
Cancer Centre of Southeastern Ontario at Kingston
🇨🇦Kingston, Ontario, Canada
Hopital Maisonneuve-Rosemont
🇨🇦Montreal, Quebec, Canada
McGill University - Dept. Oncology
🇨🇦Montreal, Quebec, Canada
CHUM - Hopital Notre-Dame
🇨🇦Montreal, Quebec, Canada
CHUQ-Pavillon Hotel-Dieu de Quebec
🇨🇦Quebec City, Quebec, Canada