Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Veterans Affairs Lung Cancer Surgery Or Stereotactic Radiotherapy (VALOR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02984761
Recruitment Status : Recruiting
First Posted : December 7, 2016
Last Update Posted : October 8, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief 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.

Condition or disease Intervention/treatment Phase
Lung Neoplasm Radiation: Stereotactic Radiotherapy Procedure: Anatomic Pulmonary Resection Not Applicable

Detailed Description:

The standard of care for stage I non-small cell lung cancer has historically been surgical resection in patients who are medically fit to tolerate an operation. Recent data now suggests that stereotactic radiotherapy may be a suitable alternative. This includes the results from a pooled analysis of two incomplete phase III studies that reported a 15% overall survival advantage with stereotactic radiotherapy at 3 years. While these data are promising, the median follow-up period was short, the results underpowered, and the findings were in contradiction to multiple retrospective studies that demonstrate the outcomes with surgery are likely equal or superior. Therefore, the herein trial aims to evaluate these two treatments in a prospective randomized fashion with a goal to compare the overall survival beyond 5 years. It has been designed to enroll patients who have a long life-expectancy, and are fit enough to tolerate an anatomic pulmonary resection with intraoperative lymph node sampling.

This study is designed to open at Veterans Affairs medical centers with expertise in both treatments. The recruitment process includes shared decision making and multi-disciplinary evaluations with lung cancer specialists. Mandatory evaluations before randomization include tissue confirmation of NSCLC, staging with FDG-PET/CT, and biopsies of all hilar and/or mediastinal lymph nodes >10mm that have a SUV >2.5. Pre-randomization elective lymph node sampling is strongly encouraged, but not required. Following treatment, patients will be followed for a minimum of 5 years.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 670 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CSP #2005 - Veterans Affairs Lung Cancer Surgery Or Stereotactic Radiotherapy Trial (VALOR)
Actual Study Start Date : April 13, 2017
Estimated Primary Completion Date : September 30, 2026
Estimated Study Completion Date : September 30, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
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.
Radiation: Stereotactic Radiotherapy
Stereotactic radiotherapy uses high doses of ionizing energy to treat cancer cells with image guidance. The treatment is delivered in an outpatient setting, and for purposes of this trial is delivered in 3-5 fractions.
Other Name: Stereotactic Body Radiation Therapy (SBRT) or Stereotactic Ablative Radiotherapy (SAbR)

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.
Procedure: Anatomic Pulmonary Resection
An anatomic pulmonary resection is an oncologic procedure that dissects out an anatomically defined segment of the lung to remove all of the lung tissue around a lung tumor. It requires an operation with general anesthesia, with a short hospital stay. The procedure entails removal of lymph nodes inside the chest that might not be easily accessible without an operation.
Other Name: Lobectomy or Anatomic Segmentectomy




Primary Outcome Measures :
  1. Overall Survival [ Time Frame: From date of randomization through study completion, up to 10 years ]
    Survival estimates will include death from any cause.


Secondary Outcome Measures :
  1. Patient reported health-related quality of life [ Time Frame: 5 years ]
    The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and Lung Cancer (LC 13) survey instruments will assess patients' general state of physical, social/family, emotional and functional well-being.

  2. Respiratory Symptoms [ Time Frame: 5 years ]
    The St George's Respiratory Questionnaire will evaluate respiratory symptoms, activity limitations from breathlessness, and impact of respiratory function on social and psychological functioning.

  3. Health State Utilities [ Time Frame: 5 years ]
    The EQ-5D-5L (EuroQOL-5D) survey will measure quality adjusted life years.

  4. Lung cancer mortality [ Time Frame: From date of randomization until date of death from any cause, assessed up to 10 years. ]
    Cause of death will be determined by an independent adjudication committee.

  5. Tumor patterns of failure [ Time Frame: 5 years ]
    Post-treatment surveillance imaging will evaluate patients every 6 months for local, regional, and/or distant disease control.

  6. Respiratory Function [ Time Frame: 5 years ]
    The Forced Expiratory Volume at 1 second (FEV1) will evaluate an objective measure of breathing function.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Inclusion Criteria for Screening

  • 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

Inclusion Criteria for Randomization

  • 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

Exclusion Criteria:

Exclusion Criteria for Screening

  • Previously evaluated by a local thoracic surgeon and determined to be medically inoperable
  • Pathological confirmation of nodal or distant metastasis
  • Prior history of lung cancer, not including current lesion
  • Prior history of thoracic surgery or lung or esophageal cancer. [prior cardiac surgery acceptable]
  • Prior history of radiotherapy to the thorax
  • Prior history of an invasive malignancy within the past 5 years, whether newly diagnosed or recurrent, excluding low-risk prostate cancer, non-melanoma skin cancers, and in-situ cancers
  • Ever diagnosed with stage IV metastatic cancer of any type
  • History of scleroderma
  • Positive Pregnancy test (for women <61 years of age or without prior hysterectomy)

Exclusion Criteria for Randomization

  • Pathological confirmation of nodal or metastatic disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02984761


Contacts
Layout table for location contacts
Contact: Drew Moghanaki, MD MPH (804) 306-9045 Drew.Moghanaki@va.gov
Contact: Vicki L Skinner, RN (894) 675-5105 vicki.skinner@va.gov

Locations
Layout table for location information
United States, California
VA Long Beach Healthcare System, Long Beach, CA Recruiting
Long Beach, California, United States, 90822
Contact: Bahman Saatian, MD    562-826-5591    bahman.saatian@va.gov   
Contact: Gelincik K Orakcilar, MS    5628268000 ext 24172    gelincik.orakcilar@va.gov   
United States, Florida
Bay Pines VA Healthcare System, Pay Pines, FL Recruiting
Bay Pines, Florida, United States, 33744
Contact: Edward Hong, MD    727-398-6661 ext 6661    edward.hong@va.gov   
Contact: Ryan J Burri, MD    7273986661 ext 13912    ryan.burri@va.gov   
United States, Georgia
Atlanta VA Medical and Rehab Center, Decatur, GA Active, not recruiting
Decatur, Georgia, United States, 30033
United States, Illinois
Edward Hines Jr. VA Hospital, Hines, IL Recruiting
Hines, Illinois, United States, 60141-5000
Contact: Cheryl Czerlanis, MD       Cheryl.Czerlanis@va.gov   
Contact: Eliza Kintanar, RN       Eliza.kintanar@va.gov   
United States, Indiana
Richard L. Roudebush VA Medical Center, Indianapolis, IN Recruiting
Indianapolis, Indiana, United States, 46202-2884
Contact: Catherine Sears, MD       Catherine.Sears@va.gov   
Contact: Sharon Weitlauf, RN       Sharon.Weitlauf@va.gov   
United States, Minnesota
Minneapolis VA Health Care System, Minneapolis, MN Recruiting
Minneapolis, Minnesota, United States, 55417
Contact: Erin Wetherbee, MD       Erin.Wetherbee.@va.gov   
Contact: Aimee Hamel    6124675806    Aimee.Hamel@va.gov   
United States, North Carolina
Durham VA Medical Center, Durham, NC Recruiting
Durham, North Carolina, United States, 27705
Contact: Scott Shofer, MD       Scott.Shofer@va.gov   
Contact: Melissa A Wagner, BS    9192860411 ext 7599    melissa.wagner2@va.gov   
United States, Pennsylvania
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA Recruiting
Pittsburgh, Pennsylvania, United States, 15240
Contact: Charles W Atwood, MD    412-360-6316    charles.atwood@va.gov   
Contact: Gregory A Owens, BA    4123601517    gregory.owens@va.gov   
United States, Texas
Michael E. DeBakey VA Medical Center, Houston, TX Recruiting
Houston, Texas, United States, 77030
Contact: Lorraine Cornwell, MD       Lorraine.Cornwell@va.gov   
Contact: Adriana M Rueda, MS    7137947459      
United States, Virginia
Hunter Holmes McGuire VA Medical Center, Richmond, VA Recruiting
Richmond, Virginia, United States, 23249
Contact: Leonard C Moses, MD    804-675-5606    Leonard.Moses@va.gov   
Contact: Pamela Parker, RN    8046755000 ext 6136    Pamela.Parker8@va.gov   
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Layout table for investigator information
Study Chair: Drew Moghanaki, MD MPH Atlanta VA Medical and Rehab Center, Decatur, GA
Study Chair: David H Harpole, MD Durham VA Medical Center, Durham, NC

Additional Information:
Layout table for additonal information
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02984761     History of Changes
Other Study ID Numbers: 2005
First Posted: December 7, 2016    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by VA Office of Research and Development:
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:
Layout table for MeSH terms
Lung Neoplasms
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases