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Comparing surgery and stereotactic radiotherapy for early-stage lung cancer

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

Not applicable Interventional VA Office of Research and Development · NCT02984761

This study is testing whether surgery or a type of targeted radiation treatment is better for people with early-stage lung cancer in helping them live longer.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment670 (estimated)
Ages18 Years and up
SexAll
SponsorVA Office of Research and Development Federal
Drugs / interventionschemotherapy, immunotherapy, radiation
Locations17 sites (Long Beach, California and 16 other locations)
Trial IDNCT02984761 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to compare the effectiveness of surgical resection versus stereotactic radiotherapy in patients with stage I non-small cell lung cancer (NSCLC). Historically, surgery has been the standard treatment for patients fit for operation, but recent data suggests that stereotactic radiotherapy may offer similar outcomes. The study will enroll patients who are medically fit and have a long life expectancy, with a focus on evaluating overall survival beyond five years. Participants will undergo thorough evaluations, including tissue confirmation and staging, before being randomized to one of the two treatment arms.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 or older with biopsy-proven stage I non-small cell lung cancer and a Karnofsky performance status of 70 or higher.

Not a fit: Patients with advanced lung cancer or those unable to tolerate surgery or stereotactic radiotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide evidence for a less invasive treatment option for early-stage lung cancer, potentially improving patient quality of life.

How similar studies have performed: While there have been retrospective studies suggesting surgery may be superior, this trial is novel in its prospective randomized approach to directly compare the two treatment modalities.

Eligibility criteria

Show full inclusion / exclusion 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 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.
* 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)

Exclusion Criteria for Randomization

* Pathological confirmation of nodal or metastatic disease

Where this trial is running

Long Beach, California and 16 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Lung NeoplasmCarcinoma, Non-Small Cell LungRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.