Stereotactic Body Radiation Therapy in Treating Patients With Stage I or Stage II Non-Small Cell Lung Cancer That Can Be Removed By Surgery

Radiation Therapy Oncology Group

Status and phase

Completed

Phase 2

Conditions

Lung Cancer

Treatments

Radiation: SBRT

Study type

Interventional

Funder types

Other

NETWORK

NIH

Identifiers

NCT00551369

RTOG-0618

CDR0000571744

Details and patient eligibility

About

RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue near the tumor.

PURPOSE: This phase II trial is studying how well stereotactic body radiation therapy works in treating patients with stage I or stage II non-small cell lung cancer that can be removed by surgery.

Full description

OBJECTIVES:

Primary

Determine whether treatment with radiotherapy involving a high biological dose with limited treatment volume (using stereotactic body radiotherapy [SBRT] techniques) achieves acceptable primary tumor control (i.e., ≥ 90% at 2 years) in patients with resectable early-stage non-small cell lung cancer.

Secondary

Determine whether treatment with radiotherapy involving a high biological dose with limited treatment volume (using SBRT techniques) achieves acceptable treatment-related toxicity.
Estimate the disease-free survival and the overall survival rate at 2 years.
Observe patterns of failure in the first 2 years.
Assess the level of comorbidity burden on morbidity and efficacy.
Determine if blood markers prior to, during the course of treatment (between the second and the last dose of SBRT), and at the first follow-up after SBRT predict 2-year primary tumor control and predict for grade ≥ 2 treatment-related toxicities

OUTLINE: This is a multicenter study.

Patients receive 3 fractions of stereotactic body radiotherapy over 14 days. Patients with disease progression undergo surgical resection as salvage local therapy.

After completion of study therapy, patients are followed every 3 months for 2 years, every 6 months for 3 years and then annually thereafter.

Enrollment

33 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed non-small cell lung cancer, including any of the following primary tumor types:
- Squamous cell carcinoma
- Adenocarcinoma
- Large cell carcinoma
- Large cell neuroendocrine tumor
- Non-small cell carcinoma not otherwise specified
No pure type bronchoalveolar cell carcinoma
Stage I or II disease based on 1 of the following combinations of primary tumor, regional nodes, metastasis (TNM) staging:
- T1, N0, M0
- T2 (≤ 5 cm), N0, M0
- T3 (≤ 5 cm), N0, M0 (chest wall primary tumors only)
No T2 or T3 primary tumors > 5 cm or T3 primary tumors involving the central chest and structures of the mediastinum
No primary tumor of any T-stage within or touching the zone of the proximal bronchial tree, defined as a volume of 2 cm in all directions around the proximal bronchial tree (carina, right and left main bronchi, right and left upper lobe bronchi, intermedius bronchus, right middle lobe bronchus, lingular bronchus, or right and left lower lobe bronchi)
Patients with hilar or mediastinal lymph nodes ≤ 1 cm AND no abnormal hilar or mediastinal uptake on positron emission tomography (PET) scan will be considered N0
- Patients with > 1 cm hilar or mediastinal lymph nodes on CT scan OR abnormal PET scan (including suspicious but nondiagnostic uptake) will still be eligible if directed tissue biopsies of all abnormally identified areas are negative for cancer
No direct evidence of regional or distant metastases after appropriate staging studies
Considered a reasonable candidate for surgical resection of the primary tumor, according to the following criteria:
- Primary tumor predicted to be technically resectable with a high likelihood of negative surgical margins (as determined by a qualified thoracic surgeon)
- Baseline forced expiratory volume (FEV)_1 > 35% predicted
- Postoperative predicted FEV_1 > 30% predicted
- Diffusion capacity > 35% predicted
- No hypoxemia (e.g., partial pressure of arterial oxygen (PaO2) of ≤ 60 mm Hg) and/or hypercapnia (e.g., partial pressure of arterial carbon dioxide (PaCO2) > 50 mm Hg) at baseline
- No severe pulmonary hypertension
- No severe cerebral, cardiac, or peripheral vascular disease
- No severe chronic heart disease
Pleural effusion, if present, must be deemed too small to tap under CT scan guidance and must not be evident on chest x-ray
- Pleural effusion that appears on chest x-ray will be allowed only after thoracotomy or other invasive procedure

PATIENT CHARACTERISTICS:

Zubrod performance status 0-1
Absolute neutrophil count ≥ 1,800/mm³
Platelet count ≥ 100,000/mm^3
Hemoglobin ≥ 8.0 g/dL (transfusion allowed)
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No synchronous primary or other invasive malignancy within the past 3 years other than nonmelanoma skin cancer or in situ cancer
No active systemic, pulmonary, or pericardial infection
No weight loss > 5% for any reason within the past 3 months

PRIOR CONCURRENT THERAPY:

No prior radiotherapy for lung cancer
- Prior radiotherapy as part of treatment for head and neck cancer, breast cancer, or other non-lung cancer is allowed provided there will not be significant overlap with the stereotactic body radiotherapy fields
No prior chemotherapy or surgical resection for this lung cancer
No other concurrent local or regional antineoplastic therapy (including standard fractionated radiotherapy, non-approved systemic therapy, and surgery), except at disease progression