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

NCT00551369 | Completed Phase 2 Results DMC

• 2 other identifiers: RTOG-0618CDR0000571744
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 19

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.

Conditions

Lung Cancer

Keywords

stage I non-small cell lung cancer; stage II non-small cell lung cancer; adenocarcinoma of the lung; large cell lung cancer; squamous cell lung cancer; adenosquamous cell lung cancer

Outcome Measures

Primary Outcomes (1)

• Primary Tumor Control at 2 Years

  Primary tumor control is defined as the absence of primary tumor failure by 2 years after the start of SBRT. Primary tumor failure was considered as the development of either failure within the SBRT treatment fields (in-field failure) or failure within 1.0 cm of the treatment field (marginal failure). An acceptable tumor control rate at 2 years was considered to be 90% (monthly hazard of 0.00439), and an unacceptable rate was 70% (monthly hazard of 0.01486). A one-sided type 1 error of 0.05 and statistical power of 90% was used. A one-sided Z-test was used to determine if the difference between the logarithm of the observed hazard rate and the logarithm of the hypothesized hazard rate of 0.01486 was statistically significant.

  From start of treatment to 2 years.

Secondary Outcomes (5)

• Rate of Treatment-related Grade 3 or 4 Toxicity

  From start of treatment to end of follow-up. Analysis can occur at or after time of primary outcome measure analysis.

• Other Grade 3-5 Adverse Events

  From start of treatment to end of follow-up. Analysis can occur at or after time of primary outcome measure analysis.

• Primary Tumor Failure (PTF), Marginal Failure (MF), Regional Failure (RF), Metastatic Dissemination (MD), Disease-free Survival (DFS), and Overall Survival (OS) at 2 Years

  From start of treatment to 2 years.

• Level of Comorbidity Burden on Morbidity and Efficacy

  From start of treatment to end of follow-up.

• Assessment of Predictive Value of Blood Markers for Primary Tumor Control at 2 Years and Treatment-related Adverse Events ≥ Grade 2

  From start of treatment to 2 years.

Study Arms (1)

SBRT

EXPERIMENTAL

Stereotactic body radiation therapy (SBRT)

Radiation: SBRT

Interventions

SBRT RADIATION

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

Also known as: Stereotactic body radiation therapy, Stereotactic ablative radiotherapy, SABR

SBRT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed non-small cell lung cancer, including any of the following primary tumor types: * Squamous cell carcinoma * Adenocarcinoma * Large cell carcinoma * Large cell neuroendocrine tumor * Non-small cell carcinoma not otherwise specified * No pure type bronchoalveolar cell carcinoma * Stage I or II disease based on 1 of the following combinations of primary tumor, regional nodes, metastasis (TNM) staging: * T1, N0, M0 * T2 (≤ 5 cm), N0, M0 * T3 (≤ 5 cm), N0, M0 (chest wall primary tumors only) * No T2 or T3 primary tumors \> 5 cm or T3 primary tumors involving the central chest and structures of the mediastinum * No primary tumor of any T-stage 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 (carina, right and left main bronchi, right and left upper lobe bronchi, intermedius bronchus, right middle lobe bronchus, lingular bronchus, or right and left lower lobe bronchi) * Patients with hilar or mediastinal lymph nodes ≤ 1 cm AND no abnormal hilar or mediastinal uptake on positron emission tomography (PET) scan will be considered N0 * Patients with \> 1 cm hilar or mediastinal lymph nodes on CT scan OR abnormal PET scan (including suspicious but nondiagnostic uptake) will still be eligible if directed tissue biopsies of all abnormally identified areas are negative for cancer * 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Radiation Therapy Oncology Group: lead
• National Cancer Institute (NCI): collaborator
• NRG Oncology: collaborator

Study Sites (19)

UAB Comprehensive Cancer Center

Birmingham, Alabama, 35294, United States

Location

Alta Bates Summit Comprehensive Cancer Center

Berkeley, California, 94704, United States

Location

Mercy Cancer Center at Mercy San Juan Medical Center

Carmichael, California, 95608, United States

Location

Marin Cancer Institute at Marin General Hospital

Greenbrae, California, 94904, United States

Location

University of California Davis Cancer Center

Sacramento, California, 95817, United States

Location

Memorial Hospital of South Bend

South Bend, Indiana, 46601, United States

Location

Lucille P. Markey Cancer Center at University of Kentucky

Lexington, Kentucky, 40536-0093, United States

Location

Greenebaum Cancer Center at University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Lacks Cancer Center at Saint Mary's Health Care

Grand Rapids, Michigan, 49503, United States

Location

William Beaumont Hospital - Royal Oak Campus

Royal Oak, Michigan, 48073, United States

Location

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

St Louis, Missouri, 63110, United States

Location

NYU Cancer Institute at New York University Medical Center

New York, New York, 10016, United States

Location

Stony Brook University Cancer Center

Stony Brook, New York, 11794-9446, United States

Location

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157-1096, United States

Location

Penn State Cancer Institute at Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033-0850, United States

Location

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

Dallas, Texas, 75390, United States

Location

INOVA Alexandria Hospital

Alexandria, Virginia, 22304, United States

Location

St. Joseph Cancer Center

Bellingham, Washington, 98225, United States

Location

Medical College of Wisconsin Cancer Center

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (1)

• 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.

  PMID: 29852037 DERIVED

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma of Lung

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Results Point of Contact

• Title: Wendy Seiferheld, M.S.
• Organization: NRG Oncology

seiferheldw@nrgoncology.org

Study Officials

• Robert D. Timmerman, MD

  Simmons Cancer Center

  PRINCIPAL INVESTIGATOR

• Elizabeth M. Gore, MD

  Medical College of Wisconsin

  STUDY CHAIR

• Harvey I. Pass, MD

  NYU Langone Health

  STUDY CHAIR

• Martin J. Edelman, MD

  University of Maryland Greenebaum Cancer Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2007
• First Posted: October 31, 2007
• Study Start: December 1, 2007
• Primary Completion: May 1, 2012
• Study Completion: May 14, 2018
• Last Updated: April 30, 2019
• Results First Posted: October 27, 2016

Record last verified: 2019-03

Locations

US (19)