Surgery With or Without Internal Radiation Therapy in Treating Patients With Stage I Non-Small Cell Lung Cancer

NCT ID: NCT00107172

Last Updated: 2019-10-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 224 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-07-31
• Study Completion Date: 2019-02-15

Brief Summary

This randomized phase III trial studies surgery and internal radiation therapy to see how well they work compared to surgery alone in treating patients with stage I non-small cell lung cancer. Surgery 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. It is not yet known whether surgery and internal radiation therapy are more effective than surgery alone in treating non-small cell lung cancer.

Detailed Description

PRIMARY OBJECTIVES:

I. To ascertain whether patients treated by sublobar resection (SR) + brachytherhapy (BX) have longer time to local recurrence as compared to the patients treated by SR (local recurrence includes recurrence within the same lobe or hilum [N1 nodes], or progression at the staple line after treatment effects such as scarring have subsided).

SECONDARY OBJECTIVES:

I. To compare procedure specific morbidity and mortality between study arms. II. To compare overall survival and failure-free survival between study arms. III. To assess freedom from regional or distant recurrence. IV. To assess the effect of histological or cytologic positive resection margins on time to local recurrence.

V. To determine the effect of brachytherapy on quality of life (QoL). VI. To determine the effect of brachytherapy on pulmonary function.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients undergo open or thoracoscopic sublobar resection comprising either a wedge resection or anatomical segmentectomy.

ARM II: Patients undergo surgery as in arm I. Patients also undergo intraoperative brachytherapy comprising iodine I 125 implant at the resection margin.

After completion of study treatment, patients are followed at 3, 6, 12, 18, 24, 30, and 36 months and then yearly for 2 years.

Conditions

Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm I

Patients undergo open or thoracoscopic sublobar resection comprising either a wedge resection or anatomical segmentectomy.

Group Type: ACTIVE_COMPARATOR

surgery

Intervention Type: PROCEDURE

Arm II

Patients undergo surgery as in arm I. Patients also undergo intraoperative brachytherapy comprising an iodine I 125 implant at the resection margin.

Group Type: EXPERIMENTAL

surgery

Intervention Type: PROCEDURE

brachytherapy

Intervention Type: RADIATION

Interventions

surgery

Intervention Type: PROCEDURE

brachytherapy

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• PART I: PRE-OPERATIVE CRITERIA (PRE-REGISTRATION/RANDOMIZATION)
• Patients must have a suspicious lung nodule for clinical stage I non-small cell lung cancer (NSCLC)
• Patient must have a mass =< 3 cm maximum diameter by computed tomography (CT) size estimate: clinical stage Ia or selected Ib (i.e., with visceral pleural involvement)
• Patient must have a CT scan of the chest with upper abdomen within 60 days prior to date of pre-registration
• Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status 0, 1, or 2
• Patient must meet at least one major criteria or meet a minimum of two minor criteria as described below:

• Major criteria

• Forced expiratory volume in 1 second (FEV1) =< 50% predicted
• Diffusing capacity of the lungs for carbon monoxide (DLCO) =< 50% predicted
• Minor criteria

• Age >= 75
• FEV1 51-60% predicted
• DLCO 51-60% predicted
• Pulmonary hypertension (defined as a pulmonary artery systolic pressure greater than 40 mmHg) as estimated by echocardiography or right heart catheterization
• Poor left ventricular function (defined as an ejection fraction of 40% or less)
• Resting or exercise partial pressure of oxygen (pO2) =< 55 mm Hg or peripheral capillary oxygen saturation (SpO2) =< 88%
• Partial pressure of carbon dioxide (pCO2) > 45 mm Hg
• Modified Medical Research Council (MMRC) Dyspnea Scale >= 3
• Patient must not have had previous intra-thoracic radiation therapy
• Women of child-bearing potential must have negative serum or urine pregnancy test
• No prior invasive malignancy, unless disease-free for >= 5 years prior to pre-registration (exceptions: non-melanoma skin cancer, in-situ cancers)
• PART II: INTRA-OPERATIVE CRITERIA (REGISTRATION)
• Patient must have biopsy-proven NSCLC
• Patient must have all suspicious mediastinal lymph nodes (> 1 cm short-axis dimension on CT scan or positive on positron emission tomography [PET] scan) assessed by one of the following methods to confirm negative involvement with NSCLC (mediastinoscopy, endo-esophageal ultrasound guided needle aspiration, CT-guided, video-assisted thoracoscopic or open lymph node biopsy)

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

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Alliance for Clinical Trials in Oncology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hiran C. Fernando, MD

Role: STUDY_CHAIR

Boston Medical Center

Locations

Mayo Clinic Scottsdale

Scottsdale, Arizona, United States

University of California Davis Cancer Center

Sacramento, California, United States

Mayo Clinic - Jacksonville

Jacksonville, Florida, United States

Winship Cancer Institute of Emory University

Atlanta, Georgia, United States

Evanston Hospital

Evanston, Illinois, United States

Cancer Institute at St. John's Hospital

Springfield, Illinois, United States

Regional Cancer Center at Memorial Medical Center

Springfield, Illinois, United States

Simmons Cooper Cancer Institute

Springfield, Illinois, United States

Cancer Institute at St. Joseph Medical Center

Towson, Maryland, United States

Boston University Cancer Research Center

Boston, Massachusetts, United States

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Mayo Clinic Cancer Center

Rochester, Minnesota, United States

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

St Louis, Missouri, United States

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Valley Hospital - Ridgewood

Ridgewood, New Jersey, United States

South Nassau Communities Hospital

Oceanside, New York, United States

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

Rochester, New York, United States

SUNY Upstate Medical University Hospital

Syracuse, New York, United States

Presbyterian Cancer Center at Presbyterian Hospital

Charlotte, North Carolina, United States

Charles M. Barrett Cancer Center at University Hospital

Cincinnati, Ohio, United States

Knight Cancer Institute at Oregon Health and Science University

Portland, Oregon, United States

Jameson Memorial Hospital - North Campus

New Castle, Pennsylvania, United States

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

Philadelphia, Pennsylvania, United States

Fox Chase Cancer Center - Philadelphia

Philadelphia, Pennsylvania, United States

Allegheny Cancer Center at Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

UPMC Cancer Centers

Pittsburgh, Pennsylvania, United States

McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center

Reading, Pennsylvania, United States

Rhode Island Hospital Comprehensive Cancer Center

Providence, Rhode Island, United States

Miriam Hospital

Providence, Rhode Island, United States

U.T. Medical Center Cancer Institute

Knoxville, Tennessee, United States

Methodist Hospital

Houston, Texas, United States

Jon and Karen Huntsman Cancer Center at Intermountain Medical Center

Murray, Utah, United States

University of Virginia Cancer Center

Charlottesville, Virginia, United States

Floyd and Delores Jones Cancer Institute at Virginia Mason Medical Center

Seattle, Washington, United States

Swedish Cancer Institute at Swedish Medical Center - First Hill Campus

Seattle, Washington, United States

University of Wisconsin Paul P. Carbone Comprehensive Cancer Center

Madison, Wisconsin, United States

London Regional Cancer Program at London Health Sciences Centre

London, Ontario, Canada

Countries

United States; Canada

References

Smith RP, Schuchert M, Komanduri K, Burton S, Heron DE, Luketich JD, d'Amato T, Landreneau R. Dosimetric evaluation of radiation exposure during I-125 vicryl mesh implants: implications for ACOSOG z4032. Ann Surg Oncol. 2007 Dec;14(12):3610-3. doi: 10.1245/s10434-007-9624-0. Epub 2007 Oct 2.

Reference Type: BACKGROUND

PMID: 17909906 (View on PubMed)

Fernando HC, Landreneau RJ, Mandrekar SJ, Hillman SL, Nichols FC, Meyers B, DiPetrillo TA, Heron DE, Jones DR, Daly BD, Starnes SL, Tan A, Putnam JB. Thirty- and ninety-day outcomes after sublobar resection with and without brachytherapy for non-small cell lung cancer: results from a multicenter phase III study. J Thorac Cardiovasc Surg. 2011 Nov;142(5):1143-51. doi: 10.1016/j.jtcvs.2011.07.051. Epub 2011 Aug 26.

Reference Type: RESULT

PMID: 21872277 (View on PubMed)

Fernando HC, Landreneau RJ, Mandrekar SJ, Hillman SL, Nichols FC, Meyers B, DiPetrillo TA, Heron D, Jones DR, Daly BD, Starnes SL, Hatter JE, Putnam JB. The impact of adjuvant brachytherapy with sublobar resection on pulmonary function and dyspnea in high-risk patients with operable disease: preliminary results from the American College of Surgeons Oncology Group Z4032 trial. J Thorac Cardiovasc Surg. 2011 Sep;142(3):554-62. doi: 10.1016/j.jtcvs.2010.10.061. Epub 2011 Jul 2.

Reference Type: RESULT

PMID: 21724195 (View on PubMed)

Fernando HC, Landreneau RJ, Mandrekar SJ, Nichols FC, Hillman SL, Heron DE, Meyers BF, DiPetrillo TA, Jones DR, Starnes SL, Tan AD, Daly BD, Putnam JB Jr. Impact of brachytherapy on local recurrence rates after sublobar resection: results from ACOSOG Z4032 (Alliance), a phase III randomized trial for high-risk operable non-small-cell lung cancer. J Clin Oncol. 2014 Aug 10;32(23):2456-62. doi: 10.1200/JCO.2013.53.4115. Epub 2014 Jun 30.

Reference Type: RESULT

PMID: 24982457 (View on PubMed)

Fernando HC, Landreneau RJ, Mandrekar SJ, Nichols FC, DiPetrillo TA, Meyers BF, Heron DE, Hillman SL, Jones DR, Starnes SL, Tan AD, Daly BD, Putnam JB; Alliance for Clinical Trials in Oncology. Analysis of longitudinal quality-of-life data in high-risk operable patients with lung cancer: results from the ACOSOG Z4032 (Alliance) multicenter randomized trial. J Thorac Cardiovasc Surg. 2015 Mar;149(3):718-25; discussion 725-6. doi: 10.1016/j.jtcvs.2014.11.003. Epub 2014 Nov 13.

Reference Type: RESULT

PMID: 25500100 (View on PubMed)

Other Identifiers

ACOSOG-Z4032

Identifier Type: -

Identifier Source: secondary_id

CDR0000422346

Identifier Type: REGISTRY

Identifier Source: secondary_id

ACOSOG-Z4032

Identifier Type: -

Identifier Source: org_study_id