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| ID | Type | Description | Link |
|---|---|---|---|
| CAN-NCIC-BR25 | Other Identifier | PDQ | |
| CDR0000486919 | Other Identifier | PDQ |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiotherapy | Experimental | 3-dimensional conformal radiotherapy, 60 Gy in once daily 4 Gy fractions (Monday to Friday) over 3 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3-dimensional conformal radiation therapy | Radiation | 3-dimensional conformal radiotherapy, 60 Gy in once daily 4 Gy fractions (Monday to Friday) over 3 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Local tumor control rate at 2 years | Overall tumor control rate will be assessed at 6 years | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity | 6 years | |
| Disease recurrence rates | 6 years | |
| Progression-free survival |
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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:
Underlying physiological medical condition that prohibits surgery due to a low probability of tolerating general anesthesia, the operation, the postoperative recovery period, or the removal of adjacent functional lung (i.e., medically inoperable)
Cytologic specimens obtained by brushing, washing, or needle aspiration of defined lesion allowed
Must develop a radiotherapy plan that meets the dose-volume constraints for critical organs
No ataxia telangiectasia
PATIENT CHARACTERISTICS:
ECOG performance status 0-2
Not pregnant or nursing
Able and willing to complete a quality of life questionnaire unless not literate in either English or French (i.e., a translator is required to comprehend the questions and reply)
No active systemic, pulmonary, or pericardial infection
No previous malignancy except adequately treated nonmelanomatous skin cancer or carcinoma in situ of the cervix.
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Patrick CF Cheung, MD, FRCPC | Toronto Sunnybrook Regional Cancer Centre | Study Chair |
| Sergio L Faria, MD, PhD | Montreal General Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tom Baker Cancer Centre | Calgary | Alberta | T2N 4N2 | Canada | ||
| BCCA - Cancer Centre for the Southern Interior |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25074417 | Result | Cheung P, Faria S, Ahmed S, Chabot P, Greenland J, Kurien E, Mohamed I, Wright JR, Hollenhorst H, de Metz C, Campbell H, Vu TT, Karvat A, Wai ES, Ung YC, Goss G, Shepherd FA, O'Brien P, Ding K, O'Callaghan C. Phase II study of accelerated hypofractionated three-dimensional conformal radiotherapy for stage T1-3 N0 M0 non-small cell lung cancer: NCIC CTG BR.25. J Natl Cancer Inst. 2014 Jul 29;106(8):dju164. doi: 10.1093/jnci/dju164. Print 2014 Aug. |
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| 6 years |
| Overall survival | 6 years |
| Quality of life | 6 years |
| Changes in pulmonary function | 6 years |
| Kelowna |
| British Columbia |
| V1Y 5L3 |
| Canada |
| BCCA - Fraser Valley Cancer Centre | Surrey | British Columbia | V3V 1Z2 | Canada |
| BCCA - Vancouver Cancer Centre | Vancouver | British Columbia | V5Z 4E6 | Canada |
| BCCA - Vancouver Island Cancer Centre | Victoria | British Columbia | V8R 6V5 | Canada |
| CancerCare Manitoba | Winnipeg | Manitoba | R3E 0V9 | Canada |
| Atlantic Health Sciences Corporation | Saint John | New Brunswick | E2L 4L2 | Canada |
| Dr. H. Bliss Murphy Cancer Centre | St. John's | Newfoundland and Labrador | AIB 3V6 | Canada |
| QEII Health Sciences Center | Halifax | Nova Scotia | B3H 1V7 | Canada |
| Juravinski Cancer Centre at Hamilton Health Sciences | Hamilton | Ontario | L8V 5C2 | Canada |
| Cancer Centre of Southeastern Ontario at Kingston | Kingston | Ontario | K7L 5P9 | Canada |
| London Regional Cancer Program | London | Ontario | N6A 4L6 | Canada |
| Lakeridge Health Oshawa | Oshawa | Ontario | L1G 2B9 | Canada |
| Thunder Bay Regional Health Science Centre | Thunder Bay | Ontario | P7B 6V4 | Canada |
| Odette Cancer Centre | Toronto | Ontario | M4N 3M5 | Canada |
| Hopital Maisonneuve-Rosemont | Montreal | Quebec | H1T 2M4 | Canada |
| CHUM - Hopital Notre-Dame | Montreal | Quebec | H2L 4M1 | Canada |
| McGill University - Dept. Oncology | Montreal | Quebec | H2W 1S6 | Canada |
| CHUQ-Pavillon Hotel-Dieu de Quebec | Québec | Quebec | G1R 2J6 | Canada |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D000077192 | Adenocarcinoma of Lung |
| D002282 | Adenocarcinoma, Bronchiolo-Alveolar |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D020266 | Radiotherapy, Conformal |
| ID | Term |
|---|---|
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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