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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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT01336894
First received: April 15, 2011
Last updated: May 20, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Lung Cancer
Procedure: therapeutic conventional surgery
Radiation: iodine I 125
Radiation: stereotactic body radiation therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • 5-year OS rate [ Time Frame: Up to 5 years post-randomization ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Loco-regional recurrence-free survival [ Time Frame: Up to 5 years post-randomization ] [ Designated as safety issue: No ]
  • Adverse event profiles at 1, 3, 6, and 12 months post-therapy [ Time Frame: Up to 12 months post-therapy ] [ Designated as safety issue: Yes ]
  • Disease-free survival [ Time Frame: Up to 5 years post-randomization ] [ Designated as safety issue: No ]
  • Pulmonary function test values [ Time Frame: Up to 12 months post-therapy ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 420
Study Start Date: May 2011
Estimated Primary Completion Date: August 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm I
Patients undergo sublobar resection comprising either a wedge resection or anatomical segmentectomy with or without intraoperative brachytherapy comprising an iodine I 125 implant at the resection margin.
Procedure: therapeutic conventional surgery
Undergo surgery
Radiation: iodine I 125
Undergo seed implant radiotherapy
Experimental: Arm II
Patients undergo 3 fractions of stereotactic body radiation therapy at 2-8 days apart.
Radiation: stereotactic body radiation therapy
Undergo radiotherapy

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01336894

  Show 53 Study Locations
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
Investigators
Principal Investigator: Hiran C. Fernando, MD Boston Medical Center
  More Information

Additional Information:
Publications:
Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT01336894     History of Changes
Other Study ID Numbers: Z4099, U10CA076001, NCI-2011-02667, CDR0000698986
Study First Received: April 15, 2011
Last Updated: May 20, 2014
Health Authority: United States: Central Institutional Review Board

Keywords provided by Alliance for Clinical Trials in Oncology:
stage IA non-small cell lung cancer
stage IB non-small cell lung cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on November 27, 2014