A Phase II Study of Accelerated Hypofractionated 3-Dimensional Conformal Radiotherapy (3DCRT) For Inoperable Stage I/II Non-Small Cell Lung Cancer (NSCLC)
18 Years
N/A
Both
Lung Cancer
Trial Information
A Phase II Study of Accelerated Hypofractionated 3-Dimensional Conformal Radiotherapy (3DCRT) For Inoperable Stage I/II Non-Small Cell Lung Cancer (NSCLC)
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.
Inclusion Criteria
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
- 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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Local tumor control rate at 2 years
Outcome Description:
Overall tumor control rate will be assessed at 6 years
Outcome Time Frame:
2 years
Safety Issue:
No
Principal Investigator
Patrick C. F. Cheung, MD, FRCPC
Investigator Role:
Study Chair
Investigator Affiliation:
Edmond Odette Cancer Centre at Sunnybrook
Authority:
Canada: Health Canada
Study ID:
BR25
NCT ID:
NCT00346320
Start Date:
April 2006
Completion Date:
July 2013
Related Keywords:
- Lung Cancer
- 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
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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