Radiation in Stage I or Stage II Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery

NCIC Clinical Trials Group80 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Lung Cancer

Interventions

3-dimensional conformal radiation therapyRADIATION

3-dimensional conformal radiotherapy, 60 Gy in once daily 4 Gy fractions (Monday to Friday) over 3 weeks

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (19)

Tom Baker Cancer Centre

Calgary, Alberta, Canada

BCCA - Cancer Centre for the Southern Interior

Kelowna, British Columbia, Canada

Outcomes

Primary Outcomes

Local tumor control rate at 2 years

Overall tumor control rate will be assessed at 6 years

Time frame: 2 years

Secondary Outcomes

Toxicity

Time frame: 6 years

Disease recurrence rates

Time frame: 6 years

Progression-free survival

Time frame: 6 years

Overall survival

Time frame: 6 years

Quality of life

Time frame: 6 years

Changes in pulmonary function

Time frame: 6 years

Data from ClinicalTrials.gov

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