Trial Search Results

Radiation Therapy in Treating Patients With Stage I Non-Small Cell Lung Cancer

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. 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. It is not yet known which regimen of stereotactic body radiation therapy is more effective in treating patients with non-small cell lung cancer.

PURPOSE: This randomized phase II trial is studying the side effects of two radiation therapy regimens and to see how well they work in treating patients with stage I non-small cell lung cancer.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Radiation Therapy Oncology Group

Collaborator: NRG Oncology


  • Radiation: Single-fraction stereotactic body radiation therapy (SBRT)
  • Radiation: Multiple-fraction stereotactic body radiation therapy (SBRT)


Phase 2



   - Histologically or cytologically confirmed primary non-small cell lung cancer,
   including one of the following subtypes:

      - Squamous cell carcinoma

      - Adenocarcinoma

      - Large cell carcinoma

      - Large cell neuroendocrine carcinoma

      - Non-small cell carcinoma not otherwise specified

   - Stage T1-2, N0, M0 disease

      - Tumor size ≤ 5 cm

      - Hilar or mediastinal lymph nodes ≤ 1 cm with no abnormal hilar or mediastinal
      uptake on PET scan are considered N0

         - Patients with hilar or mediastinal lymph nodes > 1 cm on CT scan or abnormal
         PET scan (including suspicious but nondiagnostic uptake) are eligible
         provided directed tissue biopsies of all abnormally identified areas are
         negative for cancer

      - No regional or distant metastases

   - Peripherally located tumor

      - No primary tumor 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, right and
      left lower lobe bronchi)

      - No involvement of the central pleura and/or structures of the mediastinum

   - Resectable disease

      - Patient may have declined surgery after consulting with a thoracic surgeon

   - Patient deemed "medically inoperable", in the opinion of an experienced thoracic
   cancer clinician (thoracic surgeon, medical oncologist, radiation oncologist, or
   pulmonologist), due to a severe underlying physiological medical problem that would
   preclude surgery, including any of the following:

      - Baseline forced expiratory volume at one second (FEV1) < 40% predicted

      - Postoperative FEV1 < 30% predicted

      - Severely reduced diffusion capacity

      - Baseline hypoxemia and/or hypercapnia

      - Exercise oxygen consumption < 50% predicted

      - Severe pulmonary hypertension

      - Diabetes mellitus with severe end-stage organ damage

      - Severe cerebral, cardiac, or peripheral vascular disease

      - Severe chronic heart disease

   - Measurable disease


   - Zubrod performance status 0-2

   - Absolute neutrophil count (ANC) ≥ 1,800/mm^3

   - Platelet count ≥ 100,000/mm^3

   - Hemoglobin ≥ 8.0 g/dL (transfusion or other intervention allowed)

   - Not pregnant or nursing

   - Negative pregnancy test

   - Fertile patients must use effective contraception

   - No synchronous primary malignancy or other malignancy within the past 2 years except
   for any of the following:

      - Invasive malignancy that was definitively treated and patient remains disease
      free for > 3 years with a life expectancy of > 3 years

      - Carcinoma in situ

      - Early stage skin cancer that was definitively treated

   - No active systemic, pulmonary, or pericardial infection


   - No prior radiotherapy to the lung or mediastinum

   - No prior chemotherapy for this lung or mediastinal tumor

      - Prior chemotherapy for another invasive malignancy allowed provided it was
      definitively treated and patient remains disease free for > 3 years

   - No prior surgery for this lung or mediastinal tumor

   - No other concurrent antineoplastic therapy, including standard fractionated
   radiotherapy, chemotherapy, biological therapy, vaccine therapy, and/or surgery

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study


Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
laura gable
Not Recruiting