TerminatedPhase 3NCT01336894

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

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.

Checked against the public recordLast updated May 30, 2017 · Source: ClinicalTrials.gov

StatusTerminated
PhasePhase 3
U.S. locations53
SponsorAlliance for Clinical Trials in Oncology
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 3
Sponsor
Alliance for Clinical Trials in Oncology
Interventions being studied
Procedure: therapeutic conventional surgery; Radiation: iodine I 125; Radiation: stereotactic body radiation therapy
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

DISEASE CHARACTERISTICS: * 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 resection * 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 PATIENT CHARACTERISTICS: * 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 catheterization * Poor left ventricular function (defined as an ejection fraction of 40% or less) * 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). PRIOR CONCURRENT THERAPY: * 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • UAB Comprehensive Cancer CenterBirmingham, Alabama
  • Mayo Clinic HospitalPhoenix, Arizona
  • Mayo Clinic ScottsdaleScottsdale, Arizona
  • University of California Davis Cancer CenterSacramento, California
  • UCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California
  • Stanford Cancer CenterStanford, California
  • Baptist Cancer Institute - JacksonvilleJacksonville, Florida
  • M.D. Anderson Cancer Center at OrlandoOrlando, Florida
  • Emory Crawford Long HospitalAtlanta, Georgia
  • Winship Cancer Institute of Emory UniversityAtlanta, Georgia
  • Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical CenterSavannah, Georgia
  • University of Chicago Cancer Research CenterChicago, Illinois

Source and freshness
Processed from ClinicalTrials.gov. Last public update: May 30, 2017. Always confirm current availability with the study team.

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