Evidence map›Paper›PMID 42548402›Full record

ArticleCHEST pulmonary2023

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.

Drew Moghanaki, Tomer Karas, Robert D Timmerman, Robert B Cameron, Timothy A Ritter, Hairong Shi, Matthew K Leiner, Hua Feng, Vicki L Skinner, Lisa Robin and 7 more

Registry-linked trialAbstract read
In one paragraph

Article in CHEST pulmonary, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02984761 (CSP #2005 - Veterans Affairs Lung Cancer Surgery Or Stereotactic Radiotherapy Trial), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02984761 narecruitingnot on this map

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

TypeinterventionalSponsorVA Office of Research and DevelopmentRan2017 to 2034Enrolled670ConditionsLung NeoplasmArmsStereotactic Radiotherapy, Anatomic Pulmonary Resection
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors.

Drew MoghanakiRadiation Oncology Service, Veterans Affairs Greater Los Angeles Healthcare System, Los Angeles, CA.
Tomer KarasAdventHealth Orlando, Orlando, FL.
Robert D TimmermanDepartment of Radiation Oncology, University of Texas Southwestern Medical Center, Dallas, TX.
Robert B CameronDivision of Thoracic Surgery, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, CA.
Timothy A RitterRadiation Oncology Service, Central Virginia Veterans Affairs Health Care System, Richmond, VA.
Hairong ShiVeterans Affairs Cooperative Studies Program, Hines, IL.
Matthew K LeinerVeterans Affairs Cooperative Studies Program, Hines, IL.
Hua FengVeterans Affairs Cooperative Studies Program, Hines, IL.
Vicki L SkinnerRadiation Oncology Service, Veterans Affairs Greater Los Angeles Healthcare System, Los Angeles, CA.
Lisa RobinVeterans Affairs Cooperative Studies Program, Hines, IL.
Cheryl OdleVeterans Affairs Cooperative Studies Program, Hines, IL.
Tom SindowskiVeterans Affairs Cooperative Studies Program, Hines, IL.
Amanda J SnodgrassClinical Research Pharmacy Coordinating Center, Veterans Affairs Cooperative Studies Program, Albuquerque, NM.
Grant D HuangOffice of Research and Development, Department of Veterans Affairs, Washington, DC.
Domenic J RedaUniversity of Illinois Chicago, Chicago, IL.
David H HarpoleThoracic Surgery Service, Durham Veterans Affairs Health Care System, Durham, NC.
Veterans Affairs Lung Cancer Surgery or Stereotactic Radiotherapy Study Team

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Standard-of-care treatment options for stage I non-small cell lung cancer (NSCLC) include surgery and stereotactic body radiation therapy (SBRT). Notwithstanding a lack of prospective evidence demonstrating superior long-term survival with either of these treatments, evidence-based guidelines currently recommend only surgery for patients with operable disease and to limit SBRT for patients with inoperable disease. Research Question: Do surgery or SBRT lead to superior survival rates for operable stage I NSCLC? Study Design and Methods: A phase 3 randomized clinical trial was designed to compare the overall survival (OS) rates after surgery or SBRT for stage I NSCLC. Eligible participants must have biopsy-confirmed NSCLC measuring ≤ 5 cm in maximum diameter located > 1 cm from the trachea, proximal bronchial tree, esophagus, and spinal cord. Participants must be staged with fluorodeoxyglucose PET scans with mandatory biopsies of all radiographic areas concerning for regional or distant metastatic disease. The planned accrual is 670 patients to detect a 10% absolute benefit in 5-year OS with surgery or SBRT. Secondary outcome measures include patient-reported quality of life, respiratory function, health state utilities, patterns of lung cancer relapse, and causes of mortality by independent adjudication. Results: The study was initiated in April 2017 with a planned ramp-up phase at six Veterans Affairs medical centers. Adapted recruitment interventions contributed to overcoming historical barriers to randomizing eligible participants between surgery and SBRT, and the study was expanded to 16 sites in May 2019. As of July 5, 2023, 280 of 670 planned participants have been enrolled. Interpretation: The final results are expected to clarify the role of SBRT in lieu of surgery for patients with operable stage I NSCLC and to facilitate more informed discussions about these treatment options. Trial Registry: ClinicalTrials.gov; No.: NCT02984761; URL: www.clinicaltrials.gov.

Indexed as

clinical trialearly stagelobectomynon-small cell lung cancerphase 3randomizedsegmentectomystereotactic body radiation therapythoracic surgery

Identifiers

PMID42548402
PMCPMC13418897

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.