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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT00087438
First received: July 8, 2004
Last updated: February 25, 2014
Last verified: February 2014
  Purpose

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 tissue.

PURPOSE: This phase II trial is studying how well stereotactic body radiation therapy works in treating patients with inoperable stage I or stage II non-small cell lung cancer.


Condition Intervention Phase
Lung Cancer
Radiation: stereotactic body radiation therapy
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of Stereotactic Body Radiation Therapy (SBRT) in the Treatment of Patients With Medically Inoperable Stage I/II Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Radiation Therapy Oncology Group:

Primary Outcome Measures:
  • Local Control at 2 Years [ Time Frame: From the start of treatment to 2 years ] [ Designated as safety issue: No ]
    Local control is defined as absence of local failure. (Detailed criteria for local failure is too long to include here.)


Secondary Outcome Measures:
  • Treatment-related Grade 3 or 4 Toxicity [ Time Frame: From the start of treatment to end of follow-up ] [ Designated as safety issue: Yes ]
  • Rates of Local Recurrence, Regional Recurrence, Disseminated Recurrence, Disease-free and Overall Survival at 2 Years [ Time Frame: From the start of treatment to 2 years ] [ Designated as safety issue: No ]

Enrollment: 59
Study Start Date: May 2004
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stereotactic body radiation therapy (SBRT)
20 Gy per fraction for 3 fractions over 1.5-2 weeks, for a total of 60 Gy
Radiation: stereotactic body radiation therapy

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 cell lung cancer.

Secondary

  • Determine treatment-related toxicity in patients treated with this therapy.
  • Determine disease-free survival, overall survival, and patterns of failure in patients treated with this therapy.

OUTLINE: This is a multicenter study.

Patients receive 3 fractions of stereotactic body radiotherapy over 8-14 days in the absence of disease progression or unacceptable toxicity.

Patients are followed up at 6 and 12 weeks, every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 52 patients will be accrued for this study within 26 months.

  Eligibility

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

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
  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: NCT00087438

Locations
United States, New York
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States, 14642
United States, Texas
M.D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators
Radiation Therapy Oncology Group
Investigators
Principal Investigator: Robert D. Timmerman, MD Simmons Cancer Center
  More Information

Additional Information:
Publications:
Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00087438     History of Changes
Other Study ID Numbers: RTOG-0236, CDR0000371578
Study First Received: July 8, 2004
Results First Received: February 25, 2014
Last Updated: February 25, 2014
Health Authority: United States: Federal Government

Keywords provided by Radiation Therapy Oncology Group:
stage I non-small cell lung cancer
stage II non-small cell lung cancer
squamous cell lung cancer
large cell lung cancer
adenocarcinoma of the lung
bronchoalveolar 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 October 23, 2014