Lung Cancer
Conditions
Keywords
stage I non-small cell lung cancer, squamous cell lung cancer, large cell lung cancer, adenocarcinoma of the lung, adenosquamous cell lung cancer, bronchoalveolar cell lung cancer
Brief summary
RATIONALE: Specialized 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: Phase I trial to study the effectiveness of specialized high-dose radiation therapy in treating patients who have stage I non-small cell lung cancer and lung dysfunction.
Detailed description
OBJECTIVES: * Determine the maximum tolerated course of accelerated 3-dimensional conformal radiotherapy in patients with stage I non-small cell lung cancer with pulmonary dysfunction. * Determine the short-term and long-term toxicity of this regimen in these patients. * Determine local tumor control, failure-free survival, and overall survival in patients treated with this regimen. * Determine the effect of radiotherapy dose volume relationships and pre-treatment pulmonary function studies on the incidence of pulmonary toxicity in these patients. OUTLINE: This is a dose-escalation, multicenter study. Patients receive accelerated 3-dimensional (3-D) conformal radiotherapy daily 5 days a week for 3.5-6 weeks. Cohorts of 8 patients receive escalating fractions of accelerated 3-D conformal radiotherapy until the maximum tolerated course is determined. The maximum tolerated course is defined as the course at which no more than 2 patients develop at least grade 3 dose-limiting toxicity and no more than 1 patient develops at least grade 4 dose-limiting toxicity. Patients are followed at 3 weeks, 6 weeks, 3 months, every 3 months for 2 years, and then every 6 months for 3 years.
Interventions
RADIATIONaccelerated conformational radiotherapy
Sponsors
National Cancer Institute (NCI)
Alliance for Clinical Trials in Oncology
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed stage I (T1-2, N0) non-small cell lung cancer (NSCLC) * Squamous cell carcinoma * Basaloid carcinoma * Adenocarcinoma * Bronchoalveolar carcinoma * Adenosquamous carcinoma * Large cell carcinoma * Large cell neuroendocrine carcinoma * Giant cell carcinoma * Sarcomatoid carcinoma * Non-small cell carcinoma not otherwise specified * Tridimensionally measurable solitary parenchymal lung lesion no greater than 4 cm in diameter by chest CT scan (lung windows) * No metastatic disease or hilar or mediastinal lymphadenopathy * Must have mediastinoscopy\* (anterior, cervical, or both) if mediastinal lymph nodes are greater than 1.0 cm in diameter by chest CT scan * No positive lymph nodes on mediastinoscopy\* NOTE: \*Patients may have positron-emission tomography in lieu of mediastinoscopy provided there is no fludeoxyglucose F 18 uptake in the mediastinum and hilum * Poor surgical risk, as defined by 1 of the following: * High risk due to nonpulmonary reasons, such as renal failure, cardiac failure, or hepatic dysfunction and deemed by thoracic surgeon to be unsuitable for lobectomy * Pulmonary dysfunction indicated by one or more of the following: * FEV\_1 less than 40% of predicted * DLCO less than 50% of predicted * Oxygen dependent * Chronic PaCO\_2 greater than 45 mm Hg * VO\_2 less than 15 mL/kg/min PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * 0-2 Other: * Not pregnant or nursing * Fertile patients must use effective contraception * No weight loss of more than 10% within the past 6 months * No other active (less than 30% risk of relapse after completion of prior therapy) malignancy except nonmelanoma skin cancer Chemotherapy: * No prior chemotherapy for NSCLC Radiotherapy: * No prior chest radiotherapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | Up to 5 years |
| Failure-free survival | Up to 5 years |
Countries
United States
Outcome results
None listed