Stereotactic Body Radiation Therapy in Treating Patients With Stage I or Stage II Non-Small Cell Lung Cancer That Can Be Removed By Surgery

NCT ID: NCT00551369

Last Updated: 2019-04-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-31
• Study Completion Date: 2018-05-14

Brief Summary

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

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

Detailed Description

OBJECTIVES:

Primary

• Determine whether treatment with radiotherapy involving a high biological dose with limited treatment volume (using stereotactic body radiotherapy [SBRT] techniques) achieves acceptable primary tumor control (i.e., ≥ 90% at 2 years) in patients with resectable early-stage non-small cell lung cancer.

Secondary

• Determine whether treatment with radiotherapy involving a high biological dose with limited treatment volume (using SBRT techniques) achieves acceptable treatment-related toxicity.
• Estimate the disease-free survival and the overall survival rate at 2 years.
• Observe patterns of failure in the first 2 years.
• Assess the level of comorbidity burden on morbidity and efficacy.
• Determine if blood markers prior to, during the course of treatment (between the second and the last dose of SBRT), and at the first follow-up after SBRT predict 2-year primary tumor control and predict for grade ≥ 2 treatment-related toxicities

OUTLINE: This is a multicenter study.

Patients receive 3 fractions of stereotactic body radiotherapy over 14 days. Patients with disease progression undergo surgical resection as salvage local therapy.

After completion of study therapy, patients are followed every 3 months for 2 years, every 6 months for 3 years and then annually thereafter.

Conditions

Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SBRT

Stereotactic body radiation therapy (SBRT)

Group Type: EXPERIMENTAL

SBRT

Intervention Type: RADIATION

SBRT delivered in 3 fractions of 20 Gy/fraction over 1.5 to 2 weeks for a total of 60 Gy

Interventions

SBRT

SBRT delivered in 3 fractions of 20 Gy/fraction over 1.5 to 2 weeks for a total of 60 Gy

Intervention Type: RADIATION

Other Intervention Names

Stereotactic body radiation therapy; Stereotactic ablative radiotherapy; SABR

Eligibility Criteria

Inclusion Criteria

• No direct evidence of regional or distant metastases after appropriate staging studies
• Considered a reasonable candidate for surgical resection of the primary tumor, according to the following criteria:

• Primary tumor predicted to be technically resectable with a high likelihood of negative surgical margins (as determined by a qualified thoracic surgeon)
• Baseline forced expiratory volume (FEV)_1 > 35% predicted
• Postoperative predicted FEV_1 > 30% predicted
• Diffusion capacity > 35% predicted
• No hypoxemia (e.g., partial pressure of arterial oxygen (PaO2) of ≤ 60 mm Hg) and/or hypercapnia (e.g., partial pressure of arterial carbon dioxide (PaCO2) > 50 mm Hg) at baseline
• No severe pulmonary hypertension
• No severe cerebral, cardiac, or peripheral vascular disease
• No severe chronic heart disease
• Pleural effusion, if present, must be deemed too small to tap under CT scan guidance and must not be evident on chest x-ray

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

PATIENT CHARACTERISTICS:

• Zubrod performance status 0-1
• Absolute neutrophil count ≥ 1,800/mm³
• Platelet count ≥ 100,000/mm^3
• Hemoglobin ≥ 8.0 g/dL (transfusion allowed)
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No synchronous primary or other invasive malignancy within the past 3 years other than nonmelanoma skin cancer or in situ cancer
• No active systemic, pulmonary, or pericardial infection
• No weight loss > 5% for any reason within the past 3 months

PRIOR CONCURRENT THERAPY:

• No prior radiotherapy for lung cancer

• Prior radiotherapy as part of treatment for head and neck cancer, breast cancer, or other non-lung cancer is allowed provided there will not be significant overlap with the stereotactic body radiotherapy fields
• No prior chemotherapy or surgical resection for this lung cancer
• No other concurrent local or regional antineoplastic therapy (including standard fractionated radiotherapy, non-approved systemic therapy, and surgery), except at disease progression

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

NRG Oncology

OTHER

Sponsor Role: collaborator

Radiation Therapy Oncology Group

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert D. Timmerman, MD

Role: PRINCIPAL_INVESTIGATOR

Simmons Cancer Center

Elizabeth M. Gore, MD

Role: STUDY_CHAIR

Medical College of Wisconsin

Harvey I. Pass, MD

Role: STUDY_CHAIR

NYU Langone Health

Martin J. Edelman, MD

Role: STUDY_CHAIR

University of Maryland Greenebaum Cancer Center

Locations

UAB Comprehensive Cancer Center

Birmingham, Alabama, United States

Alta Bates Summit Comprehensive Cancer Center

Berkeley, California, United States

Mercy Cancer Center at Mercy San Juan Medical Center

Carmichael, California, United States

Marin Cancer Institute at Marin General Hospital

Greenbrae, California, United States

University of California Davis Cancer Center

Sacramento, California, United States

Memorial Hospital of South Bend

South Bend, Indiana, United States

Lucille P. Markey Cancer Center at University of Kentucky

Lexington, Kentucky, United States

Greenebaum Cancer Center at University of Maryland Medical Center

Baltimore, Maryland, United States

Lacks Cancer Center at Saint Mary's Health Care

Grand Rapids, Michigan, United States

William Beaumont Hospital - Royal Oak Campus

Royal Oak, Michigan, United States

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

St Louis, Missouri, United States

NYU Cancer Institute at New York University Medical Center

New York, New York, United States

Stony Brook University Cancer Center

Stony Brook, New York, United States

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, United States

Penn State Cancer Institute at Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas

Dallas, Texas, United States

INOVA Alexandria Hospital

Alexandria, Virginia, United States

St. Joseph Cancer Center

Bellingham, Washington, United States

Medical College of Wisconsin Cancer Center

Milwaukee, Wisconsin, United States

Countries

United States

References

Timmerman RD, Paulus R, Pass HI, Gore EM, Edelman MJ, Galvin J, Straube WL, Nedzi LA, McGarry RC, Robinson CG, Schiff PB, Chang G, Loo BW Jr, Bradley JD, Choy H. Stereotactic Body Radiation Therapy for Operable Early-Stage Lung Cancer: Findings From the NRG Oncology RTOG 0618 Trial. JAMA Oncol. 2018 Sep 1;4(9):1263-1266. doi: 10.1001/jamaoncol.2018.1251.

Reference Type: DERIVED

PMID: 29852037 (View on PubMed)

Related Links

http://meetinglibrary.asco.org/content/111599-132

RTOG 0618 ASCO 2013 abstract

Other Identifiers

CDR0000571744

Identifier Type: -

Identifier Source: secondary_id

RTOG-0618

Identifier Type: -

Identifier Source: org_study_id