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Status:

COMPLETED

Stereotactic Body Radiation Therapy in Treating Patients With Inoperable Stage I or Stage II Non-Small Cell Lung Cancer

Lead Sponsor:

Radiation Therapy Oncology Group

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Lung Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Stereotactic body radiation therapy may be able to deliver x-rays directly to the tumor and cause less damage to normal tiss...

Detailed Description

OBJECTIVES: Primary * Determine whether treatment with stereotactic body radiotherapy results in acceptable local control (i.e., ≥ 80%) in patients with medically inoperable stage I or II non-small ...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
  • The following primary cancer subtypes are eligible:
  • Squamous cell carcinoma
  • Adenocarcinoma
  • Large cell carcinoma
  • Bronchoalveolar cell carcinoma
  • Non-small cell carcinoma not otherwise specified
  • Stage I or II disease based on 1 of the following tumor node metastasis (TNM) stage criteria:
  • T1, N0, M0
  • T2 (≤ 5 cm), N0, M0
  • T3 (≤ 5 cm), N0, M0 (chest wall primary tumors only)
  • No primary tumor of any T-stage within or touching the zone of the proximal bronchial tree\* NOTE: \*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, and right and left lower lobe bronchi)
  • No primary T3 tumors involving the central chest (≤ 2 cm toward carina invasion) or structures of the mediastinum
  • Any hilar or mediastinal lymph nodes \> 1 cm on CT scan OR demonstrating suspicious uptake on positron-emission tomography scan must be biopsied and confirmed negative for NSCLC
  • The primary tumor must be deemed technically resectable with a reasonable possibility of obtaining a gross total resection with negative margins (defined as a potentially curative resection (PCR))
  • Deemed medically inoperable based on pulmonary function for surgical resection of NSCLC secondary to an underlying physiological problem, including any of the following medical conditions\*:
  • Baseline forced expiratory volume (FEV)\_1\< 40% of predicted
  • Postoperative predicted FEV\_1 \< 30% of predicted
  • Severely reduced diffusion capacity
  • Baseline hypoxemia and/or hypercapnia
  • Exercise oxygen consumption \< 50% of predicted
  • Severe pulmonary hypertension
  • Diabetes mellitus with severe end organ damage
  • Severe cerebral, cardiac, or peripheral vascular disease
  • Severe chronic heart disease NOTE: \*Patients who refuse a PCR due to preference, ideology, emotional or psychological issues, mental illness, or inability to give informed consent are not eligible
  • No evidence of regional or distant metastases
  • PATIENT CHARACTERISTICS:
  • Age
  • 18 and over
  • Performance status
  • Zubrod 0-2
  • Life expectancy
  • Not specified
  • Hematopoietic
  • Not specified
  • Hepatic
  • Not specified
  • Renal
  • Not specified
  • Cardiovascular
  • See Disease Characteristics
  • No active pericardial infection
  • Pulmonary
  • See Disease Characteristics
  • No active pulmonary infection
  • Other
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No active systemic infection
  • No other concurrent illness that would preclude study participation
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • No concurrent biologic therapy
  • No concurrent vaccine therapy
  • Chemotherapy
  • No concurrent chemotherapy
  • Endocrine therapy
  • Not specified
  • Radiotherapy
  • No prior lung or mediastinal radiotherapy
  • No concurrent standard fractionated radiotherapy
  • No concurrent intensity modulated radiotherapy
  • No concurrent cobalt-60 or charged particle beams (including electrons, protons, or heavier ions)
  • Surgery
  • See Disease Characteristics
  • No concurrent surgery
  • Other
  • No other concurrent antineoplastic therapy

Exclusion

    Key Trial Info

    Start Date :

    May 1 2004

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    December 1 2016

    Estimated Enrollment :

    59 Patients enrolled

    Trial Details

    Trial ID

    NCT00087438

    Start Date

    May 1 2004

    End Date

    December 1 2016

    Last Update

    January 16 2019

    Active Locations (2)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (2 locations)

    1

    James P. Wilmot Cancer Center at University of Rochester Medical Center

    Rochester, New York, United States, 14642

    2

    M.D. Anderson Cancer Center at University of Texas

    Houston, Texas, United States, 77030-4009