Surgery With or Without Internal Radiation Therapy Compared With Stereotactic Body Radiation Therapy in Treating Patients With High-Risk Stage I Non-Small Cell Lung Cancer

NCT01336894 | Terminated Phase 3 Results DMC

• 4 other identifiers: Z4099U10CA076001NCI-2011-02667CDR0000698986
• Study Type: interventional
• Target: 13
• Locations: 2 countries
• Sites: 53

Brief Summary

RATIONALE: Surgery with or without internal radiation therapy may be an effective treatment for non-small cell lung cancer. Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. It is not yet known whether stereotactic body radiation therapy is more effective than surgery with or without internal radiation therapy in treating non-small cell lung cancer. PURPOSE: This randomized phase III trial is studying how well surgery with or without internal radiation therapy works compared with stereotactic body radiation therapy in treating patients with high-risk stage IA or stage IB non-small cell lung cancer.

Conditions

Lung Cancer

Keywords

stage IA non-small cell lung cancer; stage IB non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

• 3-year Overall Survival (OS) Rate

  Overall survival is defined as the time from randomization until death from any cause.

  Up to 3 years post-randomization

Secondary Outcomes (6)

• Loco-regional Recurrence-free Survival

  Up to 5 years post-randomization

• Adverse Event Profiles at 1 Month Post-therapy

  1 month post-therapy

• Adverse Event Profiles at 3 Months Post-therapy

  3 months post-therapy

• Adverse Event Profiles at 12 Months Post-therapy

  12 months post-therapy

• Disease-free Survival

  Up to 5 years post-randomization

Study Arms (2)

Arm I (SR+Brachytherapy)

ACTIVE COMPARATOR

Patients undergo sublobar resection comprising either a wedge resection or anatomical segmentectomy with or without intraoperative brachytherapy comprising an iodine I 125 implant at the resection margin.

Procedure: therapeutic conventional surgery; Radiation: iodine I 125

Arm II (SBRT)

EXPERIMENTAL

Patients undergo 3 fractions of stereotactic body radiation therapy at 2-8 days apart.

Radiation: stereotactic body radiation therapy

Interventions

therapeutic conventional surgery PROCEDURE

Undergo surgery

Arm I (SR+Brachytherapy)

iodine I 125 RADIATION

Undergo seed implant radiotherapy

Arm I (SR+Brachytherapy)

stereotactic body radiation therapy RADIATION

Undergo radiotherapy

Arm II (SBRT)

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Lung nodule suspicious for non-small cell lung cancer (NSCLC) * Biopsy confirmation is strongly recommended but not required; if biopsy is attempted and non-diagnostic, if the patient refuses biopsy, or if the risk of biopsy is considered too high, patients may be enrolled if the mass is suspicious for NSCLC based on two or more of the following criteria: * Positive smoking history * Absence of benign calcifications within suspicious nodule * Activity on PET greater than normal tissue * Evidence of growth compared to previous imaging * Presence of spiculation * Tumor ≤ 4 cm maximum diameter, clinical stage IA or selected IB (i.e., with visceral pleural involvement) by PET/CT scan of the chest and upper abdomen performed within 60 days prior to registration * All clinically suspicious mediastinal N1, N2, or N3 lymph nodes (\> 1 cm short-axis dimension on CT scan and/or positive on PET scan) confirmed negative for involvement with NSCLC by one of the following methods: mediastinoscopy, anterior mediastinotomy, endoscopic and/or endobronchial ultrasonography (EUS/EBUS)-guided needle aspiration, CT-guided, or video-assisted thoracoscopic or open lymph node biopsy * Tumor verified by a thoracic surgeon to be in a location that will permit sublobar resection * Tumor located peripherally within the lung, defined as not touching any surface within 2 cm of the proximal bronchial tree in all directions * Patients with non-peripheral (central) tumors are NOT eligible * No evidence of distant metastases PATIENT CHARACTERISTICS: * ECOG performance status (PS) 0, 1, or 2 * Patient at high-risk for surgery by meeting a minimum of one major criteria or two minor criteria as described below: * Major criteria * FEV1 ≤ 50% predicted * DLCO ≤ 50% predicted * Minor criteria * Age ≥ 75 years * FEV1 51-60% predicted * DLCO 51-60% predicted * Pulmonary hypertension (defined as a pulmonary artery systolic pressure greater than 40 mm Hg) as estimated by echocardiography or right heart catheterization * Poor left ventricular function (defined as an ejection fraction of 40% or less) * Resting or exercise arterial pO2 ≤ 55 mm Hg or SpO2 ≤ 88% * pCO2 \> 45 mm Hg * Modified Medical Research Council (MMRC) Dyspnea Scale ≥ 3 * Not pregnant or nursing * Negative urine or serum pregnancy test * Fertile patients must use effective contraception * No prior invasive malignancy, unless disease-free for ≥ 3 years prior to registration (except non-melanoma skin cancer, in-situ cancers). PRIOR CONCURRENT THERAPY: * No prior intra-thoracic radiotherapy * Prior radiotherapy as part of treatment for head and neck, breast, or other non-thoracic cancer is permitted * Prior chemotherapy or surgical resection for the lung cancer being treated on this protocol is NOT permitted

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

Sponsors & Collaborators

• Alliance for Clinical Trials in Oncology: lead
• National Cancer Institute (NCI): collaborator

Study Sites (53)

UAB Comprehensive Cancer Center

Birmingham, Alabama, 35294, United States

Location

Mayo Clinic Hospital

Phoenix, Arizona, 85054, United States

Location

Mayo Clinic Scottsdale

Scottsdale, Arizona, 85259-5499, United States

Location

University of California Davis Cancer Center

Sacramento, California, 95817, United States

Location

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

Stanford Cancer Center

Stanford, California, 94305-5824, United States

Location

Baptist Cancer Institute - Jacksonville

Jacksonville, Florida, 32207, United States

Location

M.D. Anderson Cancer Center at Orlando

Orlando, Florida, 32806, United States

Location

Emory Crawford Long Hospital

Atlanta, Georgia, 30308, United States

Location

Winship Cancer Institute of Emory University

Atlanta, Georgia, 30322, United States

Location

Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center

Savannah, Georgia, 31403-3089, United States

Location

University of Chicago Cancer Research Center

Chicago, Illinois, 60637-1470, United States

Location

OSF St. Francis Medical Center

Peoria, Illinois, 61637, United States

Location

Lucille P. Markey Cancer Center at University of Kentucky

Lexington, Kentucky, 40536-0093, United States

Location

James Graham Brown Cancer Center at University of Louisville

Louisville, Kentucky, 40202, United States

Location

DeCesaris Cancer Institute at Anne Arundel Medical Center

Annapolis, Maryland, 21401, United States

Location

Greenebaum Cancer Center at University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

St. Agnes Hospital Cancer Center

Baltimore, Maryland, 21229, United States

Location

Tufts Medical Center Cancer Center

Boston, Massachusetts, 02111, United States

Location

Boston University Cancer Research Center

Boston, Massachusetts, 02118, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109-0942, United States

Location

William Beaumont Hospital - Royal Oak Campus

Royal Oak, Michigan, 48073, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

St Louis, Missouri, 63110, United States

Location

Valley Hospital - Ridgewood

Ridgewood, New Jersey, 07450, United States

Location

St. Luke's - Roosevelt Hospital Center - St.Luke's Division

New York, New York, 10025, United States

Location

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

Rochester, New York, 14642, United States

Location

Stony Brook University Cancer Center

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

Location

SUNY Upstate Medical University Hospital

Syracuse, New York, 13210, United States

Location

Wake Forest University Comprehensive Cancer Center

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

Location

Charles M. Barrett Cancer Center at University Hospital

Cincinnati, Ohio, 45267, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210-1240, United States

Location

Providence Cancer Center at Providence Portland Medical Center

Portland, Oregon, 97213-2967, United States

Location

Geisinger Cancer Institute at Geisinger Health

Danville, Pennsylvania, 17822-0001, United States

Location

Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

Philadelphia, Pennsylvania, 19107-5541, United States

Location

Allegheny Cancer Center at Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

York Cancer Center at Apple Hill Medical Center

York, Pennsylvania, 17405, United States

Location

Hollings Cancer Center at Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Baylor University Medical Center - Dallas

Dallas, Texas, 75246, United States

Location

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

Dallas, Texas, 75390, United States

Location

University of Virginia Cancer Center

Charlottesville, Virginia, 22908, United States

Location

Sentara Cancer Institute at Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States

Location

Providence Regional Cancer Partnership

Everett, Washington, 98201, United States

Location

Swedish Cancer Institute at Swedish Medical Center - First Hill Campus

Seattle, Washington, 98122-4307, United States

Location

Gundersen Lutheran Center for Cancer and Blood

La Crosse, Wisconsin, 54601, United States

Location

Medical College of Wisconsin Cancer Center

Milwaukee, Wisconsin, 53226, United States

Location

Veterans Affairs Medical Center - Milwaukee

Milwaukee, Wisconsin, 53295, United States

Location

Waukesha Memorial Hospital Regional Cancer Center

Waukesha, Wisconsin, 53188, United States

Location

London Regional Cancer Program at London Health Sciences Centre

London, Ontario, N6A 4L6, Canada

Location

Ottawa Hospital Regional Cancer Centre - General Campus

Ottawa, Ontario, K1Y 4E9, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Hopital Notre-Dame du CHUM

Montreal, Quebec, H2L 4M1, Canada

Location

Related Publications (1)

• Fernando HC, Timmerman R. American College of Surgeons Oncology Group Z4099/Radiation Therapy Oncology Group 1021: a randomized study of sublobar resection compared with stereotactic body radiotherapy for high-risk stage I non-small cell lung cancer. J Thorac Cardiovasc Surg. 2012 Sep;144(3):S35-8. doi: 10.1016/j.jtcvs.2012.06.003. Epub 2012 Jul 11.

  PMID: 22795435 RESULT

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Iodine-125; Radiosurgery

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Hiran C. Fernando, MD
• Organization: Boston Medical Center

hiran.fernando@bmc.org

617-638-5600

Study Officials

• Hiran C. Fernando, MD

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2011
• First Posted: April 18, 2011
• Study Start: May 1, 2011
• Primary Completion: May 1, 2013
• Study Completion: March 27, 2017
• Last Updated: May 30, 2017
• Results First Posted: March 28, 2017

Record last verified: 2017-04

Locations

CA (4); US (49)