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

Not Recruiting

Trial ID: NCT00960999


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.

Official Title

A Randomized Phase II Study Comparing 2 Stereotactic Body Radiation Therapy (SBRT) Schedules for Medically Inoperable Patients With Stage I Peripheral Non-Small Cell Lung Cancer

Stanford Investigator(s)


Professor of Radiation Oncology (Radiation Therapy)

Heather Wakelee
Heather Wakelee

Winston Chen and Phyllis Huang Professor

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)

A. Dimitrios Colevas, MD
A. Dimitrios Colevas, MD

Professor of Medicine (Oncology) and, by courtesy, of Otolaryngology - Head & Neck Surgery (OHNS) and of Radiation Oncology (Radiation Therapy)


Inclusion Criteria:

   1. Histological confirmation (by biopsy or cytology) of non-small cell lung cancer
   (NSCLC) prior to treatment; the following primary cancer types are eligible: squamous
   cell carcinoma, adenocarcinoma, large cell carcinoma, large cell neuroendocrine, or
   non-small cell carcinoma not otherwise specified; Note: although bronchioloalveolar
   cell carcinoma is a subtype of NSCLC, patients with the pure type of this malignancy
   are excluded from this study because the spread of this cancer between adjacent
   airways is difficult to target on computed tomography (CT).

   2. Stage T1, N0, M0 or T2 (≤ 5 cm), N0, M0, (AJCC Staging, 6th Ed.), based upon #3.

   3. Minimum diagnostic workup:

      - History/physical examination, including weight and assessment of Zubrod
      performance status, within 4 weeks prior to registration;

      - Evaluation by an experienced thoracic cancer clinician (a thoracic surgeon,
      medical oncologist, radiation oncologist, or pulmonologist) within 8 weeks prior
      to registration;

      - CT scan with intravenous contrast (unless medically contraindicated) within 8
      weeks prior to registration of the entirety of both lungs and the mediastinum,
      liver, and adrenal glands; the primary tumor dimension will be measured on the
      CT. Positron emission tomography (PET) evaluation of the liver and adrenal glands
      also is permitted. In addition, if the enrolling institution has a combined
      PET/CT scanner and both aspects are of diagnostic quality and read by a trained
      radiologist, the PET/CT will meet the staging requirements for both CT and PET.

      - Whole body or wide field FDG-PET within 8 weeks prior to registration with
      adequate visualization of the primary tumor and draining lymph node basins in the
      hilar and mediastinal regions and adrenal glands; in the event of lung
      consolidation, atelectasis, inflammation or other confounding features, PET-based
      imaging correlated with CT imaging will establish the maximal tumor dimensions.
      Standardized uptake value (SUV) must be measured on PET. To be included in this
      analysis, the patient's PET studies must be performed with a dedicated bismuth
      germanium oxide (BGO), lutetium oxyorthosilicate (LSO), or gadolinium
      oxyorthosilicate (GSO) PET or PET/CT scanner. PET scanners with sodium iodide
      (Nal) detectors are not acceptable. If the baseline PET study is performed at the
      treating institution (or its affiliated PET facility), it is recommended that the
      reassessment PET scans be performed at the same site.

      - Pulmonary function tests (PFTs): Routine spirometry, lung volumes, and diffusion
      capacity, within 8 weeks prior to registration; arterial blood gases are
      optional. Note: All patients enrolled in this study must have these pulmonary
      assessments whether or not the reason for their medical inoperability is
      pulmonary based, since the objective assessment of pulmonary factors is a
      component of the outcomes assessment for this study.

   4. Patients with hilar or mediastinal lymph nodes ≤ 1cm and no abnormal hilar or
   mediastinal uptake on PET will be considered N0. Patients with > 1 cm hilar or
   mediastinal lymph nodes on CT or abnormal PET (including suspicious but non-diagnostic
   uptake) may still be eligible if directed tissue biopsy of all abnormally identified
   areas are negative for cancer.

   5. The patient's resectable NSCLC must be considered medically inoperable by an
   experienced thoracic cancer clinician (a thoracic surgeon, medical oncologist,
   radiation oncologist, or pulmonologist) or a standard lobectomy and mediastinal lymph
   node dissection/sampling procedure. The patient may have underlying physiological
   medical problems that would prohibit a surgery due to a low probability of tolerating
   general anesthesia, the operation, the postoperative recovery period, or the removal
   of adjacent functioning lung. These types of patients with severe underlying health
   problems are deemed "medically inoperable." Standard justification for deeming a
   patient medically inoperable based on pulmonary function for surgical resection of
   NSCLC may include any of the following:

      - Baseline forced expiratory volume in 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 organ damage;

      - Severe cerebral, cardiac, or peripheral vascular disease;

      - Severe chronic heart disease. If the patient has resectable disease but declines
      surgery after consulting with a thoracic surgeon, he/she will be considered

   6. The patient must have measurable disease.

   7. Zubrod Performance Status 0-2;

   8. Age ≥ 18;

   9. Negative serum or urine pregnancy test within 72 hours prior to registration for women
   of childbearing potential;

10. Women of childbearing potential and male participants must agree to use a medically
   effective means of birth control, such as condom/diaphragm and spermicidal foam,
   intrauterine device (IUD), or prescription birth control pills, throughout their
   participation in the treatment phase of the study

11. The patient must provide study specific informed consent prior to study entry.

Exclusion Criteria:

   1. Patients with T2 primary tumors > 5 cm or involving the central plural and/or
   structures of the mediastinum;

   2. The primary tumor of any T-stage within or touching the zone of the proximal bronchial
   tree, defined as a volume 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

   3. Direct evidence of regional or distant metastases after appropriate staging studies,
   or synchronous primary malignancy or prior malignancy in the past 2 years except for
   invasive malignancy that has been treated definitively and the patient remains disease
   free for > 3 years with life expectancy of > 3 years or carcinoma in situ or early
   stage skin cancers that have been treated definitively;

   4. Previous radiotherapy to the lung or mediastinum;

   5. Previous chemotherapy for this lung or mediastinum tumor; chemotherapy for another
   invasive malignancy is permitted if it has been treated definitively and the patient
   has remained disease free for > 3 years.

   6. Previous surgery for this lung or mediastinum tumor;

   7. Plans for the patient to receive other concomitant antineoplastic therapy (including
   standard fractionated radiotherapy, chemotherapy, biological therapy, vaccine therapy,
   and surgery) while on this protocol except at disease progression;

   8. Patients with active systemic, pulmonary, or pericardial infection;

   9. Pregnant or lactating women, as treatment involves unforeseeable risks to the embryo
   or fetus.


radiation: Single-fraction stereotactic body radiation therapy (SBRT)

radiation: Multiple-fraction stereotactic body radiation therapy (SBRT)

Not Recruiting

Contact Information

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

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