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.
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
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.
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- 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.
17 sites in 1 country
United States17 sites, 12 recruiting
- 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
- Active, not recruiting
Bay Pines VA Healthcare System, Pay Pines, FL
Bay Pines, Florida, 33744-0000
- 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
- Active, not recruiting
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, 55417-2309
- Terminated
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
- Recruiting
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
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 group | Role | What they receive |
|---|---|---|
| Stereotactic radiotherapy | Experimental | 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. Receives: Radiation: Stereotactic Radiotherapy |
| Surgery | Active comparator | 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. Receives: Procedure: Anatomic Pulmonary Resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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
Health State Utilities
The EQ-5D-5L (EuroQOL-5D) survey will measure quality adjusted life years.
Measured: 5 years
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.
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
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.
- First posted7 Dec 2016 (estimated)
- Study start13 Apr 2017
- Primary completion30 Sep 2032 (estimated)
- Study completion31 Mar 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lung NeoplasmStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Drew Moghanaki, MD MPH, Study chair, VA Greater Los Angeles Healthcare System, West Los Angeles, CADavid H Harpole, MD, Study chair, Durham VA Medical Center, Durham, NC
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 42548402Elbanna 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