CSP #2005 - Veterans Affairs Lung Cancer Surgery Or Stereotactic Radiotherapy Trial (VALOR)

Who is this study for? Patients with stage I non-small cell lung cancer
Status: Recruiting
Location: See all (17) locations...
Intervention Type: Procedure, Radiation
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Patients with stage I non-small cell lung cancer have been historically treated with surgery whenever they are fit for an operation. However, an alternative treatment known as stereotactic radiotherapy now appears to offer an equally effective alternative. Doctors believe both are good treatments and are therefore conducting this study to determine if one may be possibly better than the other.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age 18 or older

• Any patient with a preliminary diagnosis of stage I Non-Small Cell Lung Cancer (NSCLC), whether pathologically proven by biopsy, or highly suspicious by radiographic imaging. \[Participants will ultimately need biopsy confirmation before enrolling\]

• Primary tumor size less than or equal to 5 cm by CT (may include CT images from PET/CT)

• Karnofsky performance status greater than or equal to 70

• Participant has willingness and ability to provided informed consent for participation

• Biopsy proven non-small cell lung cancer

• Participant's case reviewed at multidisciplinary conference

• Tumor size less than or equal to 5cm (measured on the most recent CT images available, and may include PET/CT images)

• Tumor is equal to or greater than 1.0cm from the trachea, esophagus, brachial plexus, 1st bifurcation of the proximal bronchial tree, or spinal cord (measured on the most recent CT images available, and may include PET/CT images).

• Mandatory FDG-PET/CT within 60 days of the randomization date (note: FDG-PET/CT may need to be repeated prior to treatment if outside of this requirement)

• Mandatory pathological assessment of any lymph nodes \>10mm with a SUV \>2.5 seen on FDG- PET/CT

• Mandatory biopsy of any additional concerning lesions seen on FDG-PET/CT, to make better determination that the patient is not harboring metastatic disease or a secondary primary malignancy.

• Pre-operative FEV1 greater than or equal to 40% of predicted value and pre-operative DLCO greater than or equal to 40% of predicted value.

• Formally evaluated and documented by a local thoracic surgeon to be medically fit to undergo a complete anatomic pulmonary resection (wedge resection not allowed)

• Formally evaluated and documented by a local radiation oncologist to be eligible to receive protocol-defined stereotactic radiotherapy

• Participant willingness to be randomized

Locations
United States
California
VA Long Beach Healthcare System, Long Beach, CA
RECRUITING
Long Beach
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
RECRUITING
West Los Angeles
Florida
Bay Pines VA Healthcare System, Pay Pines, FL
RECRUITING
Bay Pines
Miami VA Healthcare System, Miami, FL
RECRUITING
Miami
Illinois
Edward Hines Jr. VA Hospital, Hines, IL
RECRUITING
Hines
Indiana
Richard L. Roudebush VA Medical Center, Indianapolis, IN
RECRUITING
Indianapolis
Massachusetts
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
RECRUITING
Boston
Maryland
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
RECRUITING
Baltimore
Michigan
VA Ann Arbor Healthcare System, Ann Arbor, MI
RECRUITING
Ann Arbor
Minnesota
Minneapolis VA Health Care System, Minneapolis, MN
RECRUITING
Minneapolis
North Carolina
Durham VA Medical Center, Durham, NC
RECRUITING
Durham
Ohio
Louis Stokes VA Medical Center, Cleveland, OH
RECRUITING
Cleveland
Pennsylvania
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
TERMINATED
Philadelphia
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
TERMINATED
Pittsburgh
Texas
Michael E. DeBakey VA Medical Center, Houston, TX
RECRUITING
Houston
Virginia
Hunter Holmes McGuire VA Medical Center, Richmond, VA
TERMINATED
Richmond
Wisconsin
Clement J. Zablocki VA Medical Center, Milwaukee, WI
RECRUITING
Milwaukee
Contact Information
Primary
Drew Moghanaki, MD MPH
Drew.Moghanaki@va.gov
(804) 306-9045
Backup
Matt Leiner, MS
Matt.Leiner@va.gov
(708) 202-5853
Time Frame
Start Date: 2017-04-13
Estimated Completion Date: 2027-09-30
Participants
Target number of participants: 670
Treatments
Experimental: Stereotactic radiotherapy
Stereotactic radiotherapy is an FDA approved treatment for lung cancer. However, for purposes of this study, it is being delivered to an operable population that is typically treated with surgical resection. Participants randomized to stereotactic radiotherapy will be treated according to the location of the tumor. Peripheral tumors will receive either 18 Gy x 3, 14 Gy x 4, or 11.5 Gy x 5 fractions, while central tumors will be treated with 10 Gy x 5. There will not be any elective coverage of local microscopic spread or regional lymph nodes.
Active_comparator: Surgery
Participants randomized to surgery will undergo a standard lobectomy or limited anatomic pulmonary resection (segmentectomy) under general anesthesia. Non-anatomic (wedge) resections are not permitted. Pathological specimens must contain a separately divided pulmonary artery and bronchus, as well as sampled lymph nodes from mediastinal lymph node stations. Participants found to have incidental nodal involvement after surgery will be referred for adjuvant chemotherapy, with our without postoperative radiotherapy.
Sponsors
Leads: VA Office of Research and Development

This content was sourced from clinicaltrials.gov

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