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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 : September 24, 2020
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Tracking Information
First Submitted Date  ICMJE November 30, 2016
First Posted Date  ICMJE December 7, 2016
Last Update Posted Date September 24, 2020
Actual Study Start Date  ICMJE April 13, 2017
Estimated Primary Completion Date September 30, 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 7, 2016)
Overall Survival [ Time Frame: From date of randomization through study completion, up to 10 years ]
Survival estimates will include death from any cause.
Original Primary Outcome Measures  ICMJE
 (submitted: December 2, 2016)
Overall Survival [ Time Frame: From date of randomization through through study completion, an average of 10 years ]
Survival estimates will include death from any cause.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 14, 2016)
  • 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.
  • 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.
  • Health State Utilities [ Time Frame: 5 years ]
    The EQ-5D-5L (EuroQOL-5D) survey will measure quality adjusted life years.
  • 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.
  • 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.
  • Respiratory Function [ Time Frame: 5 years ]
    The Forced Expiratory Volume at 1 second (FEV1) will evaluate an objective measure of breathing function.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 2, 2016)
  • Patient reported health-related quality of life [ Time Frame: 5 years ]
    The EORTC QLQ-C30/LC 13 survey instruments will assess patients' general state of physical, social/family, emotional and functional well-being.
  • Respiratory Function [ 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.
  • Health State Utilities [ Time Frame: 5 years ]
    The EQ-5D-5L (EuroQOL-5D) survey will measure quality adjusted life years.
  • 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.
  • Lung cancer mortality [ Time Frame: From date of randomization through through study completion, an average of 10 years ]
    Post-treatment surveillance imaging will evaluate patients every 6 months for local, regional, and/or distant disease control.
  • Respiratory Function [ Time Frame: 5 years ]
    The Forced Expiratory Volume at 1 second (FEV1) will evaluate an objective measure of breathing function.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Veterans Affairs Lung Cancer Surgery Or Stereotactic Radiotherapy
Official Title  ICMJE CSP #2005 - Veterans Affairs Lung Cancer Surgery Or Stereotactic Radiotherapy Trial (VALOR)
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.
Detailed Description

**As a consequence of the COVID-19 pandemic, and after consultation with the appropriate research oversight, regulatory and monitoring entities, screening and enrollment has been placed on temporary administrative hold as of 03/17/2020. When such trial activities resume the clinicaltrials.gov record will be updated accordingly. As of 9/16/2020 Minneapolis, Richmond, and Houston are still on Administrative Hold for the CSP 2005 study. The other 6 sites are open for recruitment. **

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lung Neoplasm
Intervention  ICMJE
  • 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)
  • 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
Study Arms  ICMJE
  • 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.
    Intervention: Radiation: Stereotactic Radiotherapy
  • 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.
    Intervention: Procedure: Anatomic Pulmonary Resection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 2, 2016)
670
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 30, 2027
Estimated Primary Completion Date September 30, 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Drew Moghanaki, MD MPH (804) 306-9045 Drew.Moghanaki@va.gov
Contact: Vicki L Skinner, RN (894) 675-5105 vicki.skinner@va.gov
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02984761
Other Study ID Numbers  ICMJE 2005
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party VA Office of Research and Development
Study Sponsor  ICMJE VA Office of Research and Development
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account VA Office of Research and Development
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP