Status:
COMPLETED
Radiation in Stage I or Stage II Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery
Lead Sponsor:
NCIC Clinical Trials Group
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
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 ho...
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...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
- Stage I or II peripheral disease
- T1, N0, M0
- T2 (≤ 5 cm), N0, M0
- T3 (≤ 5 cm, chest wall primary tumor only), N0, M0
- No T2-T3 primary tumors \> 5 cm or any T1-T3 tumor of the mainstem bronchus involvement
- No T1-T3 tumor in the lung apex (i.e., tumor in a position that will result in irradiation of the brachial plexus to the prescribed dose)
- Hilar or mediastinal lymph nodes ≤ 1 cm considered N0
- Any of the following primary cancer types:
- Squamous cell carcinoma
- Adenocarcinoma
- Large cell carcinoma
- Bronchioloalveolar cell carcinoma
- Non-small cell carcinoma not otherwise specified
- 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
- If sputum cytology alone is used for diagnosis, it must be confirmed on a second specimen
- 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.
- Previous diagnosis of cancer that is free of recurrence and metastases for ≥ 2 years and, in the opinion of the treating physician, does not have a substantial risk of recurrence allowed (including prior lung cancer)
- PRIOR CONCURRENT THERAPY:
- No prior radiotherapy to the area of the primary tumor
- No prior or concurrent chemotherapy or immunotherapy for this tumor
Exclusion
Key Trial Info
Start Date :
August 2 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 20 2014
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00346320
Start Date
August 2 2006
End Date
August 20 2014
Last Update
August 4 2023
Active Locations (19)
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1
Tom Baker Cancer Centre
Calgary, Alberta, Canada, T2N 4N2
2
BCCA - Cancer Centre for the Southern Interior
Kelowna, British Columbia, Canada, V1Y 5L3
3
BCCA - Fraser Valley Cancer Centre
Surrey, British Columbia, Canada, V3V 1Z2
4
BCCA - Vancouver Cancer Centre
Vancouver, British Columbia, Canada, V5Z 4E6