Clinical trial · Interventional
Veterans Affairs Lung Cancer Surgery Or Stereotactic Radiotherapy
CSP #2005 - Veterans Affairs Lung Cancer Surgery Or Stereotactic Radiotherapy Trial (VALOR)
NCT02984761CI-TRIAL-00103610VALORrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Neoplasm | Lung Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anatomic Pulmonary Resection | Procedure | — | UNRESOLVED |
| Stereotactic Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Stereotactic radiotherapy
- description
- 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.
- interventionNames
- Radiation: Stereotactic Radiotherapy
- type
- ACTIVE_COMPARATOR
- label
- Surgery
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDMoghanaki 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. PMID 42548402
- DERIVEDElbanna 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. PMID 32736936