RecruitingNot applicable

Veterans Affairs Lung Cancer Surgery Or Stereotactic Radiotherapy

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Biopsies

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official eligibility 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

Study sites (17)

CA

FL

IL

IN

MA

MD

MI

MN

NC

OH

PA

TX

VA

WI