Surgery With or Without Internal Radiation Therapy Compared With Stereotactic Body Radiation Therapy in Treating Patients With High-Risk Stage I Non-Small Cell Lung Cancer

Not Recruiting

Trial ID: NCT01336894


RATIONALE: Surgery with or without internal radiation therapy may be an effective treatment for non-small cell lung cancer. Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. It is not yet known whether stereotactic body radiation therapy is more effective than surgery with or without internal radiation therapy in treating non-small cell lung cancer. PURPOSE: This randomized phase III trial is studying how well surgery with or without internal radiation therapy works compared with stereotactic body radiation therapy in treating patients with high-risk stage IA or stage IB non-small cell lung cancer.

Official Title

A Randomized Phase III Study of Sublobar Resection (+/- Brachytherapy) Versus Stereotactic Body Radiation Therapy in High Risk Patients With Stage I Non-Small Cell Lung Cancer (NSCLC)

Stanford Investigator(s)

Quynh-Thu Le, MD
Quynh-Thu Le, MD

Katharine Dexter McCormick and Stanley McCormick Memorial Professor and Professor, by courtesy, of Otolaryngology - Head & Neck Surgery (OHNS)

Joseph Shrager
Joseph Shrager

Professor of Cardiothoracic Surgery

Maximilian Diehn, MD, PhD
Maximilian Diehn, MD, PhD

Jack, Lulu, and Sam Willson Professor and Professor of Radiation Oncology (Radiation Therapy)


Professor of Radiation Oncology (Radiation Therapy)



   - Lung nodule suspicious for non-small cell lung cancer (NSCLC)

      - Biopsy confirmation is strongly recommended but not required; if biopsy is
      attempted and non-diagnostic, if the patient refuses biopsy, or if the risk of
      biopsy is considered too high, patients may be enrolled if the mass is suspicious
      for NSCLC based on two or more of the following criteria:

         - Positive smoking history

         - Absence of benign calcifications within suspicious nodule

         - Activity on PET greater than normal tissue

         - Evidence of growth compared to previous imaging

         - Presence of spiculation

   - Tumor ≤ 4 cm maximum diameter, clinical stage IA or selected IB (i.e., with visceral
   pleural involvement) by PET/CT scan of the chest and upper abdomen performed within 60
   days prior to registration

   - All clinically suspicious mediastinal N1, N2, or N3 lymph nodes (> 1 cm short-axis
   dimension on CT scan and/or positive on PET scan) confirmed negative for involvement
   with NSCLC by one of the following methods: mediastinoscopy, anterior mediastinotomy,
   endoscopic and/or endobronchial ultrasonography (EUS/EBUS)-guided needle aspiration,
   CT-guided, or video-assisted thoracoscopic or open lymph node biopsy

   - Tumor verified by a thoracic surgeon to be in a location that will permit sublobar

   - Tumor located peripherally within the lung, defined as not touching any surface within
   2 cm of the proximal bronchial tree in all directions

      - Patients with non-peripheral (central) tumors are NOT eligible

   - No evidence of distant metastases


   - ECOG performance status (PS) 0, 1, or 2

   - Patient at high-risk for surgery by meeting a minimum of one major criteria or two
   minor criteria as described below:

      - Major criteria

         - FEV1 ≤ 50% predicted

         - DLCO ≤ 50% predicted

      - Minor criteria

         - Age ≥ 75 years

         - FEV1 51-60% predicted

         - DLCO 51-60% predicted

         - Pulmonary hypertension (defined as a pulmonary artery systolic pressure
         greater than 40 mm Hg) as estimated by echocardiography or right heart

         - Poor left ventricular function (defined as an ejection fraction of 40% or

         - Resting or exercise arterial pO2 ≤ 55 mm Hg or SpO2 ≤ 88%

         - pCO2 > 45 mm Hg

         - Modified Medical Research Council (MMRC) Dyspnea Scale ≥ 3

   - Not pregnant or nursing

   - Negative urine or serum pregnancy test

   - Fertile patients must use effective contraception

   - No prior invasive malignancy, unless disease-free for ≥ 3 years prior to registration
   (except non-melanoma skin cancer, in-situ cancers).


   - No prior intra-thoracic radiotherapy

      - Prior radiotherapy as part of treatment for head and neck, breast, or other
      non-thoracic cancer is permitted

   - Prior chemotherapy or surgical resection for the lung cancer being treated on this
   protocol is NOT permitted


radiation: iodine I 125

radiation: stereotactic body radiation therapy

procedure: therapeutic conventional surgery

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305

New Trial Alerts

Receive email alerts when trials open to patients.