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Lung NeoplasmVALORNCT02984761

Veterans Affairs Lung Cancer Surgery Or Stereotactic Radiotherapy

A study testing Stereotactic Radiotherapy and Anatomic Pulmonary Resection in people with Lung Neoplasm, run by VA Office of Research and Development at 17 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Neoplasm
What is being tested?
Stereotactic Radiotherapy and Anatomic Pulmonary Resection
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
670 participants
Where
17 sitesUnited States
Study dates
13 Apr 2017to 31 Mar 2034
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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 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.
Show all 11Show fewer
  • Prior history of IV malignancy, excluding follicular lymphoma, chronic lymphocytic leukemia, or hormone sensitive prostate cancer confined to the pelvis.
  • 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)
  • Pathological confirmation of nodal or metastatic disease

Trial locations and contacts

17 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Drew Moghanaki, MD MPH contact

(804) 306-9045

Drew.Moghanaki@va.gov

Vicki L Skinner, RN contact

(894) 675-5105

vicki.skinner@va.gov

17 sites in 1 country

United States17 sites, 12 recruiting

  • VA Ann Arbor Healthcare System, Ann Arbor, MI

    Ann Arbor, Michigan, 48105-2303

    Jane Deng, MD, 734-845-3039, Jane.Deng@va.gov

    David Elliott, MD, 7348453914, David.Elliott1@va.gov

    Recruiting

  • Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

    Baltimore, Maryland, 21201

    Janaki Deepak, MD, 410-605-7000, Janaki.Deepak@va.gov

    Ma Inez A Ambata, MSN, MaInezAmparo.Ambata@va.gov

    Recruiting

  • Bay Pines VA Healthcare System, Pay Pines, FL

    Bay Pines, Florida, 33744-0000

    Active, not recruiting

  • VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

    Boston, Massachusetts, 02130-4817

    Ronald Goldstein, MD, 857-203-6478, Ronald.Goldstein@va.gov

    Kathleen Lacerda, 8572036295, Kathleen.Lacerda@va.gov

    Recruiting

  • Louis Stokes VA Medical Center, Cleveland, OH

    Cleveland, Ohio, 44106-1702

    Charles Nock, MD, 216-791-3800 ext. 64825, Charles.Nock@va.gov

    Lisa Tucker, 2167913800 ext. 63595, Lisa.Tucker@va.gov

    Recruiting

  • Durham VA Medical Center, Durham, NC

    Durham, North Carolina, 27705-3875

    Scott Shofer, MD, Scott.Shofer@va.gov

    Melissa A Wagner, BS, 9192860411 ext. 7599, Melissa.Wagner2@va.gov

    Recruiting

  • Edward Hines Jr. VA Hospital, Hines, IL

    Hines, Illinois, 60141-3030

    Zaid M Abdelsattar, MD, Zaid.Abdelsattar@va.gov

    Eliza Kintanar, RN, Eliza.Kintanar@va.gov

    Recruiting

  • Michael E. DeBakey VA Medical Center, Houston, TX

    Houston, Texas, 77030-4211

    Lorraine Cornwell, MD, Lorraine.Cornwell@va.gov

    Adriana M Rueda, MS, 7137947459, Adriana.Rueda@va.gov

    Recruiting

  • Richard L. Roudebush VA Medical Center, Indianapolis, IN

    Indianapolis, Indiana, 46202-2884

    Catherine Sears, MD, Catherine.Sears@va.gov

    Sharon Henson, RN, Sharon.Henson@va.gov

    Recruiting

  • VA Long Beach Healthcare System, Long Beach, CA

    Long Beach, California, 90822

    Bahman Saatian, MD, 562-826-5591, Bahman.Saatian@va.gov

    Gelincik Orakcilar, MS, 5628268000 ext. 24172, Gelincik.Orakcilar@va.gov

    Recruiting

  • Miami VA Healthcare System, Miami, FL

    Miami, Florida, 33125

    Gregory Holt, MD, 305-575-7000 ext. 3227, Gregory.Holt@va.gov

    Jalima Quintero, 3059928621, Jalima.Quintero@va.gov

    Recruiting

  • Clement J. Zablocki VA Medical Center, Milwaukee, WI

    Milwaukee, Wisconsin, 53295-0001

    Uzair Ghori, MD, 414-384-2000 ext. 42593, Uzair.Ghori@va.gov

    Kayla Neuendorf, BSN, Kayla.Neuendorf@va.gov

    Recruiting

  • Minneapolis VA Health Care System, Minneapolis, MN

    Minneapolis, Minnesota, 55417-2309

    Active, not recruiting

  • Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

    Philadelphia, Pennsylvania, 19104-4551

    Terminated

  • VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

    Pittsburgh, Pennsylvania, 15240

    Terminated

  • Hunter Holmes McGuire VA Medical Center, Richmond, VA

    Richmond, Virginia, 23249

    Terminated

  • VA Greater Los Angeles Healthcare System, West Los Angeles, CA

    West Los Angeles, California, 90073-1003

    Robert B Cameron, MD, (310) 794-7333, robert.cameron@va.gov

    Diane L Gage, MD, (310) 478-3711, Diane.Gage@va.gov

    Recruiting

Other trials in United States

About this study

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

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.

Read the 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.

Conditions
Lung Neoplasm
Being tested
Stereotactic Radiotherapy, Anatomic Pulmonary Resection
Keywords
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
Medical subject headings
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Respiratory Tract Neoplasms, Thoracic Neoplasms, Neoplasms by Site, Neoplasms, Lung Diseases, Respiratory Tract Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Stereotactic RadiotherapyRadiation

    Also called Stereotactic Body Radiation Therapy (SBRT) or Stereotactic Ablative Radiotherapy (SAbR)

    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.

  • Anatomic Pulmonary ResectionProcedure or surgery

    Also called Lobectomy or Anatomic Segmentectomy

    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.

Study groups in NCT02984761
Study groupRoleWhat they receive
Stereotactic radiotherapyExperimentalStereotactic 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.
Receives: Radiation: Stereotactic Radiotherapy
SurgeryActive comparatorParticipants 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.
Receives: Procedure: Anatomic Pulmonary Resection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival

    Survival estimates will include death from any cause.

    Measured: From date of randomization through study completion, up to 10 years

Secondary outcomes (6)

  1. Patient reported health-related quality of life

    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.

    Measured: 5 years

  2. Respiratory Function

    The St George's Respiratory Questionnaire will evaluate respiratory symptoms, activity limitations from breathlessness, and impact of respiratory function on social and psychological functioning.

    Measured: 5 years

  3. Health State Utilities

    The EQ-5D-5L (EuroQOL-5D) survey will measure quality adjusted life years.

    Measured: 5 years

  4. Lung cancer mortality

    Cause of death will be determined by an independent adjudication committee.

    Measured: From date of randomization until date of death from any cause, assessed up to 10 years.

  5. Tumor patterns of failure

    Post-treatment surveillance imaging will evaluate patients every 6 months for local, regional, and/or distant disease control.

    Measured: 5 years

  6. Respiratory Function

    The Forced Expiratory Volume at 1 second (FEV1) will evaluate an objective measure of breathing function.

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Dec 2016 (estimated)
  2. Study start13 Apr 2017
  3. Primary completion30 Sep 2032 (estimated)
  4. Study completion31 Mar 2034 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
670 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02984761
Sponsor's protocol ID
2005
Acronym
VALOR
Status last verified
Oct 2026
First submitted
30 Nov 2016
Last updated
23 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Moghanaki D, Karas T, Timmerman RD, Cameron RB, Ritter TA, Shi H, Leiner MK, Feng H, Skinner VL, Robin L, Odle C, Sindowski T, Snodgrass AJ, Huang GD, Reda DJ, Harpole DH; Veterans Affairs Lung Cancer Surgery or Stereotactic Radiotherapy Study Team. Protocol for the Veterans Affairs Cooperative Studies Program Study Number 2005: A Phase 3 Randomized Trial of Lung Cancer Surgery or Stereotactic Radiotherapy for Operable Early-Stage Non-Small Cell Lung Cancer. CHEST Pulm. 2023 Oct 5;1(3):100024. doi: 10.1016/j.chpulm.2023.100024. eCollection 2023 Dec.

    PubMed 42548402

  • Elbanna M, Shiue K, Edwards D, Cerra-Franco A, Agrawal N, Hinton J, Mereniuk T, Huang C, Ryan JL, Smith J, Aaron VD, Burney H, Zang Y, Holmes J, Langer M, Zellars R, Lautenschlaeger T. Impact of Lung Parenchymal-Only Failure on Overall Survival in Early-Stage Lung Cancer Patients Treated With Stereotactic Ablative Radiotherapy. Clin Lung Cancer. 2021 May;22(3):e342-e359. doi: 10.1016/j.cllc.2020.05.024. Epub 2020 Jun 2.

    PubMed 32736936

Questions about this trial

What is this clinical trial studying?

A study testing Stereotactic Radiotherapy and Anatomic Pulmonary Resection in people with Lung Neoplasm, run by VA Office of Research and Development at 17 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Drew Moghanaki, MD MPH ((804) 306-9045, Drew.Moghanaki@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (time frame: From date of randomization through study completion, up to 10 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02984761, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.

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