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Surgery

Surgery vs Stereotactic Radiotherapy for Lung Cancer (VALOR Trial)

N/A
Recruiting
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Formally evaluated and documented by a local thoracic surgeon to be medically fit to undergo a complete anatomic pulmonary resection (wedge resection not allowed)
Age 18 or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of randomization through study completion, up to 10 years
Awards & highlights

VALOR Trial Summary

This trial is testing whether surgery or stereotactic radiotherapy is better for people with stage I non-small cell lung cancer.

Who is the study for?
This trial is for adults over 18 with stage I Non-Small Cell Lung Cancer (NSCLC) that's less than or equal to 5cm, confirmed by biopsy or imaging. They must be fit for surgery or stereotactic radiotherapy, have a Karnofsky performance status of at least 70, and no history of certain cancers or thoracic treatments. Pregnant women and those with metastatic disease are excluded.Check my eligibility
What is being tested?
The study compares two treatments for early-stage lung cancer: traditional lung surgery (anatomic pulmonary resection) versus a newer approach called stereotactic radiotherapy. It aims to find out which treatment might be better by randomly assigning participants to one of the two options.See study design
What are the potential side effects?
Surgery may lead to complications like pain, infection, bleeding, and breathing problems. Stereotactic radiotherapy can cause skin reactions, fatigue, shortness of breath, chest wall pain and in rare cases damage to nearby organs such as the esophagus.

VALOR Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am considered fit for lung surgery that is not a wedge resection.
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I am 18 years old or older.
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My primary tumor is 5 cm or smaller, confirmed by a CT scan.
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My tumor is at least 1cm away from critical areas like the windpipe or spinal cord.
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My lung cancer diagnosis was confirmed through a biopsy.
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My tumor is 5cm or smaller, based on my latest scans.
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My lymph nodes larger than 10mm with high activity were checked.
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I am able to care for myself but may not be able to do active work.

VALOR Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of randomization through study completion, up to 10 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of randomization through study completion, up to 10 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Survival
Secondary outcome measures
Health State Utilities
Lung cancer mortality
Patient reported health-related quality of life
+2 more

VALOR Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Stereotactic radiotherapyExperimental Treatment1 Intervention
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.
Group II: SurgeryActive Control1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic Radiotherapy
2018
N/A
~40

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,305,763 Total Patients Enrolled
Drew Moghanaki, MD MPHStudy ChairVA Greater Los Angeles Healthcare System, West Los Angeles, CA
David H Harpole, MDStudy ChairDurham VA Medical Center, Durham, NC

Media Library

Anatomic Pulmonary Resection (Surgery) Clinical Trial Eligibility Overview. Trial Name: NCT02984761 — N/A
Lung Cancer Research Study Groups: Stereotactic radiotherapy, Surgery
Lung Cancer Clinical Trial 2023: Anatomic Pulmonary Resection Highlights & Side Effects. Trial Name: NCT02984761 — N/A
Anatomic Pulmonary Resection (Surgery) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02984761 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there currently any openings for enrolment in this trial?

"Affirmative. Clinicaltrials.gov documents corroborate that this investigation is actively accruing participants from 16 different medical centres, since it was published on April 13th 2017 and last edited September 9th 2022. The trial requires 670 enrollees in total."

Answered by AI

How many people have participated in the trial thus far?

"To conduct this clinical trial, 670 individuals who qualify for the established criteria must partake. These patients can visit two different locations: VA Greater Los Angeles Healthcare System in West Los Angeles and Michael E. DeBakey VA Medical Center in Houston, TX."

Answered by AI

How many healthcare facilities are conducting this experiment?

"This medical trial is accepting patients at VA Greater Los Angeles Healthcare System in West Los Angeles, California; Michael E. DeBakey VA Medical Center in Houston, Texas; and VA Long Beach Healthcare System in Long Beach, Massachusetts; with additional sites located across the country."

Answered by AI
~172 spots leftby Sep 2026