Trial record 1 of 1 for:    NCT00750269
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Stereotactic Body Radiation Therapy in Treating Patients With Stage I Non-Small Cell Lung Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
NRG Oncology Foundation, Inc.
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT00750269
First received: September 9, 2008
Last updated: July 21, 2014
Last verified: July 2014
  Purpose

RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue.

PURPOSE: This phase I/II trial is studying the side effects and best dose of stereotactic body radiation therapy and to see how well it works in treating patients with stage I non-small cell lung cancer.


Condition Intervention Phase
Lung Cancer
Radiation: stereotactic body radiation therapy (SBRT)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Seamless Phase I/II Study of Stereotactic Lung Radiotherapy (SBRT) for Early Stage, Centrally Located, Non-Small Cell Lung Cancer (NSCLC) in Medically Inoperable Patients

Resource links provided by NLM:


Further study details as provided by Radiation Therapy Oncology Group:

Primary Outcome Measures:
  • Maximum tolerated dose of stereotactic body radiotherapy (SBRT) as assessed by NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v4.0 (Phase I) [ Time Frame: From start of SBRT until 1 year. ] [ Designated as safety issue: Yes ]
  • To estimate the primary tumor control rate at the maximum tolerated dose (MTD) [ Time Frame: From start of SBRT until 2 years. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: From randomization to date of death, failure (local, regional or distant) or last follow-up. Analysis occurs after all patients have been potentially followed for 24 months. ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 24 months. ] [ Designated as safety issue: No ]
  • Time to local progression [ Time Frame: From randomization to date of death, regional failure or last follow-up. Analysis occurs after all patients have been potentially followed for 24 months. ] [ Designated as safety issue: No ]
  • Time to regional nodal progression [ Time Frame: From randomization to date of death, regional failure or last follow-up. Analysis occurs after all patients have been potentially followed for 24 months. ] [ Designated as safety issue: No ]
  • Time to distant metastases [ Time Frame: From randomization to date of death, distant failure or last follow-up. Analysis occurs after all patients have been potentially followed for 24 months. ] [ Designated as safety issue: No ]
  • Toxicity (other than DLT) of ≥ grade 3 as assessed by NCI CTCAE v4.0 [ Time Frame: From start of SBRT until 1 year. ] [ Designated as safety issue: Yes ]
  • Late toxicity (i.e., occurs > 1 year after the start of SBRT) of ≥ grade 3 as assessed by NCI CTCAE v4.0 [ Time Frame: From start of treatment to end of follow-up. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 110
Study Start Date: February 2009
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Level 1: 8 Gy x 5 fractions
stereotactic body radiation therapy (SBRT) of 8 Gy x 5 fractions
Radiation: stereotactic body radiation therapy (SBRT)
Experimental: Level 2: 8.5 Gy x 5 fractions
stereotactic body radiation therapy (SBRT) of 8.5 Gy x 5 fractions
Radiation: stereotactic body radiation therapy (SBRT)
Experimental: Level 3: 9 Gy x 5 fractions
stereotactic body radiation therapy (SBRT) of 9 Gy x 5 fractions
Radiation: stereotactic body radiation therapy (SBRT)
Experimental: Level 4: 9.5 Gy x 5 fractions
stereotactic body radiation therapy (SBRT) of 9.5 Gy x 5 fractions
Radiation: stereotactic body radiation therapy (SBRT)
Experimental: Level 5: 10 Gy x 5 fractions
stereotactic body radiation therapy (SBRT) of 10 Gy x 5 fractions
Radiation: stereotactic body radiation therapy (SBRT)
Experimental: Level 6: 10.5 Gy x 5 fractions
stereotactic body radiation therapy (SBRT) of 10.5 Gy x 5 fractions
Radiation: stereotactic body radiation therapy (SBRT)
Experimental: Level 7: 11 Gy x 5 fractions
stereotactic body radiation therapy (SBRT) of 11 Gy x 5 fractions
Radiation: stereotactic body radiation therapy (SBRT)
Experimental: Level 8: 11.5 Gy x 5 fractions
stereotactic body radiation therapy (SBRT) of 11.5 Gy x 5 fractions
Radiation: stereotactic body radiation therapy (SBRT)
Experimental: Level 9: 12 Gy x 5 fractions
stereotactic body radiation therapy (SBRT) of 12 Gy x 5 fractions
Radiation: stereotactic body radiation therapy (SBRT)

Detailed Description:

OBJECTIVES:

Primary

  • To determine the maximum tolerated dose (MTD) of stereotactic body radiotherapy (SBRT) in medically inoperable patients with centrally located stage I non-small cell lung cancer. (Phase I)
  • To determine the efficacy of SBRT when administered at the MTD in these patients. (Phase I)
  • To estimate the local control rate of SBRT at the MTD in these patients. (Phase II)

Secondary

  • To estimate the rates of adverse events (other than dose-limiting toxicity) of ≥ grade 3 that is possibly, probably, or definitely related to treatment and that occurs within 1 year after the start of SBRT in these patients.
  • To estimate the rates of late adverse events (i.e., occurs > 1 year after the start of SBRT) in these patients.
  • To estimate the local control and progression-free and overall survival rates in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients undergo stereotactic body radiotherapy every 2 days over 1½-2 weeks (total of 5 fractions) in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed periodically.

  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)

    • Stage T1-2, N0, M0 disease

      • Tumor size ≤ 5 cm
      • Tumor must be within or touching the zone of the proximal bronchial tree, defined as a volume of 2 cm in all directions around the proximal bronchial tree (i.e., 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 bronchi) OR immediately adjacent to the mediastinal or pericardial pleura (PTV touching the pleura)
      • Hilar or mediastinal lymph nodes ≤ 1 cm AND no abnormal hilar or mediastinal uptake on PET scan are considered N0

        • Mediastinal lymph node sampling by any technique is allowed but not required
        • Patients with > 1 cm hilar or mediastinal lymph nodes on CT scan or abnormal PET scan (including suspicious but nondiagnostic uptake) are eligible provided directed tissue biopsies of all abnormally identified areas are negative for cancer
  • Tumor deemed technically resectable, in the opinion of an experienced thoracic cancer surgeon, with a reasonable possibility of obtaining a gross total resection with negative margins, defined as a potentially curative resection (PCR)
  • Patient deemed "medically inoperable" due to severe underlying physiological medical problems that would prohibit a PCR, including any of the following:

    • Baseline forced expiratory volume at 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-stage organ damage
    • Severe cerebral, cardiac, or peripheral vascular disease
    • Severe chronic heart disease
  • Measurable disease as documented by CT scan or whole-body PET scan within the past 8 weeks

    • Patients with lesions that cannot be visualized by CT scan are not eligible
  • Pleural effusion allowed provided it is deemed too small to tap under CT guidance and is not evident on chest x-ray

    • Pleural effusion that appears on chest x-ray is allowed only after thoracotomy or other invasive procedure

PATIENT CHARACTERISTICS:

  • Zubrod performance status 0-2
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for ≥ 60 days after completion of study therapy
  • No other invasive malignancy within the past 2 years except nonmelanomatous skin cancer or carcinoma in situ of the breast, oral cavity, or cervix

    • Prior lung cancer allowed provided the patient has been disease-free for ≥ 2 years

PRIOR CONCURRENT THERAPY:

  • No prior radiotherapy to the region of the study cancer that would result in overlap of radiotherapy fields
  • No prior chemotherapy for the study cancer
  • No other concurrent local therapy (including standard-fractionated radiotherapy and/or surgery) or systemic therapy (including standard chemotherapy or biologic targeted agents) specifically intended as treatment for study cancer

    • Local or systemic therapy at the time of disease progression allowed
  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: NCT00750269

  Hide Study Locations
Locations
United States, Arizona
Arizona Center for Cancer Care - Peoria
Peoria, Arizona, United States, 85381
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259-5499
United States, California
Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center
Burbank, California, United States, 91505
Radiation Oncology Centers - Cameron Park
Cameron Park, California, United States, 95682
Mercy Cancer Center at Mercy San Juan Medical Center
Carmichael, California, United States, 95608
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
University of California Davis Cancer Center
Sacramento, California, United States, 95817
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94115
United States, Connecticut
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus
New Britain, Connecticut, United States, 06050
United States, Delaware
CCOP - Christiana Care Health Services
Newark, Delaware, United States, 19713
United States, Florida
Baptist Cancer Institute - Jacksonville
Jacksonville, Florida, United States, 32207
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
M.D. Anderson Cancer Center at Orlando
Orlando, Florida, United States, 32806
United States, Illinois
OSF St. Francis Medical Center
Peoria, Illinois, United States, 61637
United States, Kansas
CCOP - Kansas City
Prairie Village, Kansas, United States, 66208
United States, Kentucky
Lucille P. Markey Cancer Center at University of Kentucky
Lexington, Kentucky, United States, 40536-0093
Norton Suburban Hospital
Louisville, Kentucky, United States, 40207
United States, Louisiana
Tulane Cancer Center Office of Clinical Research
Alexandria, Louisiana, United States, 71315-3198
United States, Maine
Maine Center for Cancer Medicine and Blood Disorders - Scarborough
Scarborough, Maine, United States, 04074
United States, Maryland
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
United States, Michigan
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, United States, 48202
McLaren Cancer Institute
Flint, Michigan, United States, 48532
Lacks Cancer Center at Saint Mary's Health Care
Grand Rapids, Michigan, United States, 49503
Butterworth Hospital at Spectrum Health
Grand Rapids, Michigan, United States, 49503
William Beaumont Hospital - Royal Oak Campus
Royal Oak, Michigan, United States, 48073
United States, Minnesota
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids, Minnesota, United States, 55433
Mercy and Unity Cancer Center at Unity Hospital
Fridley, Minnesota, United States, 55432
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
Regions Hospital Cancer Care Center
St. Paul, Minnesota, United States, 55101
United States, Missouri
Saint Louis University Cancer Center
Saint Louis, Missouri, United States, 63110
United States, New Hampshire
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756-0002
United States, New Jersey
Cooper CyberKnife Center
Mount Laurel, New Jersey, United States, 08054
Frederick R. and Betty M. Smith Cancer Treatment Center
Sparta, New Jersey, United States, 07871
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
New York, New York, United States, 10032
St. Luke's - Roosevelt Hospital Center - St.Luke's Division
New York, New York, United States, 10025
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States, 14642
United States, North Carolina
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096
United States, Ohio
Summa Center for Cancer Care at Akron City Hospital
Akron, Ohio, United States, 44309-2090
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, United States, 45267
Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210-1240
Flower Hospital Cancer Center
Sylvania, Ohio, United States, 43560
United States, Pennsylvania
Rosenfeld Cancer Center at Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001
Dale and Frances Hughes Cancer Center at Pocono Medical Center
East Stroudsburg, Pennsylvania, United States, 18301
Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
Albert Einstein Cancer Center
Philadelphia, Pennsylvania, United States, 19141
Frankford Hospital Cancer Center - Torresdale Campus
Philadelphia, Pennsylvania, United States, 19114
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
Reading, Pennsylvania, United States, 19612-6052
Lankenau Cancer Center at Lankenau Hospital
Wynnewood, Pennsylvania, United States, 19096
United States, Texas
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States, 75390
United States, Virginia
Sentara Cancer Institute at Sentara Norfolk General Hospital
Norfolk, Virginia, United States, 23507
United States, Washington
St. Joseph Cancer Center
Bellingham, Washington, United States, 98225
University Cancer Center at University of Washington Medical Center
Seattle, Washington, United States, 98195
United States, Wisconsin
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States, 53226
Veterans Affairs Medical Center - Milwaukee
Milwaukee, Wisconsin, United States, 53295
Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
Radiation Therapy Oncology Group
NRG Oncology Foundation, Inc.
Investigators
Principal Investigator: Andrea Bezjak, MD, MSC, FRCPC Princess Margaret Hospital, Canada
Study Chair: Jeffrey Bradley, MD Mallinckrodt Institute of Radiology at Washington University Medical Center
Study Chair: Laurie E. Gaspar, MD, MBA University of Colorado, Denver
  More Information

Additional Information:
No publications provided

Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00750269     History of Changes
Obsolete Identifiers: NCT01317056
Other Study ID Numbers: RTOG-0813, CDR0000613524, NCI-2009-01095
Study First Received: September 9, 2008
Last Updated: July 21, 2014
Health Authority: United States: Federal Government

Keywords provided by Radiation Therapy Oncology Group:
stage I non-small cell lung cancer

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

ClinicalTrials.gov processed this record on August 28, 2014