RECRUITING

Veterans Affairs Lung Cancer Surgery Or Stereotactic Radiotherapy

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2017-04-13
Study Completion:2027-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02984761

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 18 or older
  2. * 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. \[Participants will ultimately need biopsy confirmation before enrolling\]
  3. * Primary tumor size less than or equal to 5 cm by CT (may include CT images from PET/CT)
  4. * Karnofsky performance status greater than or equal to 70
  5. * Participant has willingness and ability to provided informed consent for participation
  6. * Biopsy proven non-small cell lung cancer
  7. * Participant's case reviewed at multidisciplinary conference
  8. * Tumor size less than or equal to 5cm (measured on the most recent CT images available, and may include PET/CT images)
  9. * 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).
  10. * 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)
  11. * Mandatory pathological assessment of any lymph nodes \>10mm with a SUV \>2.5 seen on FDG- PET/CT
  12. * 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.
  13. * 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.
  14. * Formally evaluated and documented by a local thoracic surgeon to be medically fit to undergo a complete anatomic pulmonary resection (wedge resection not allowed)
  15. * Formally evaluated and documented by a local radiation oncologist to be eligible to receive protocol-defined stereotactic radiotherapy
  16. * Participant willingness to be randomized
  1. * Previously evaluated by a local thoracic surgeon and determined to be medically inoperable
  2. * Pathological confirmation of nodal or distant metastasis
  3. * Prior history of lung cancer, not including current lesion
  4. * Prior history of thoracic surgery or lung or esophageal cancer. \[prior cardiac surgery acceptable\]
  5. * Prior history of radiotherapy to the thorax
  6. * Prior history of invasive state I-III malignancy treated with surgery, radiation therapy, chemotherapy, immunotherapy, or targeted therapy in the past 2 years, excluding prostate cancer, low-risk papillary thyroid cancer (less than or equal to 1 cm), follicular lymphoma, or chronic lymphocytic leukemia.
  7. * Prior history of IV malignancy, excluding follicular lymphoma, chronic lymphocytic leukemia, or hormone sensitive prostate cancer confined to the pelvis.
  8. * Ever diagnosed with stage IV metastatic cancer of any type
  9. * History of scleroderma
  10. * Positive Pregnancy test (for women \<61 years of age or without prior hysterectomy)
  11. * Pathological confirmation of nodal or metastatic disease

Contacts and Locations

Study Contact

Drew Moghanaki, MD MPH
CONTACT
(804) 306-9045
Drew.Moghanaki@va.gov
Matt Leiner, MS
CONTACT
(708) 202-5853
Matt.Leiner@va.gov

Principal Investigator

Drew Moghanaki, MD MPH
STUDY_CHAIR
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
David H Harpole, MD
STUDY_CHAIR
Durham VA Medical Center, Durham, NC

Study Locations (Sites)

VA Long Beach Healthcare System, Long Beach, CA
Long Beach, California, 90822
United States
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California, 90073-1003
United States
Bay Pines VA Healthcare System, Pay Pines, FL
Bay Pines, Florida, 33744
United States
Miami VA Healthcare System, Miami, FL
Miami, Florida, 33125
United States
Edward Hines Jr. VA Hospital, Hines, IL
Hines, Illinois, 60141-3030
United States
Richard L. Roudebush VA Medical Center, Indianapolis, IN
Indianapolis, Indiana, 46202-2884
United States
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, Maryland, 21201
United States
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, 02130
United States
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, 48105-2303
United States
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, 55417
United States
Durham VA Medical Center, Durham, NC
Durham, North Carolina, 27705
United States
Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, 44106
United States
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
Philadelphia, Pennsylvania, 19104-4551
United States
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania, 15240
United States
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, 77030
United States
Hunter Holmes McGuire VA Medical Center, Richmond, VA
Richmond, Virginia, 23249
United States
Clement J. Zablocki VA Medical Center, Milwaukee, WI
Milwaukee, Wisconsin, 53295-0001
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

  • Drew Moghanaki, MD MPH, STUDY_CHAIR, VA Greater Los Angeles Healthcare System, West Los Angeles, CA
  • David H Harpole, MD, STUDY_CHAIR, Durham VA Medical Center, Durham, NC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2017-04-13
Study Completion Date2027-09-30

Study Record Updates

Study Start Date2017-04-13
Study Completion Date2027-09-30

Terms related to this study

Keywords Provided by Researchers

  • Carcinoma, Non-Small Cell Lung
  • Respiratory Tract Neoplasms
  • Thoracic Neoplasms
  • Neoplasms by Site
  • Neoplasms
  • Lung Diseases
  • Respiratory Tract Diseases
  • Carcinoma, Bronchogenic
  • Bronchial Neoplasms
  • Radiosurgery
  • Radiotherapy
  • Radiotherapy, Image-Guided
  • Lung Neoplasms

Additional Relevant MeSH Terms

  • Lung Neoplasm