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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

Must not have

Positive Pregnancy test (for women <61 years of age or without prior hysterectomy)

Ever diagnosed with stage IV metastatic cancer of any type

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from date of randomization through study completion, up to 10 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am a woman under 61 or haven't had a hysterectomy and my pregnancy test is positive.

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I have been diagnosed with stage IV cancer.

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I have a history of scleroderma.

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My cancer has spread to my lymph nodes or other parts of my body.

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My cancer has spread to my lymph nodes or other parts of my body.

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I have had lung cancer before, but not including my current condition.

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A thoracic surgeon has deemed me inoperable.

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I have had radiation therapy to my chest area before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of randomization through study completion, up to 10 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall Survival

Secondary study objectives

Health State Utilities

Lung cancer mortality

Patient reported health-related quality of life

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 16Eligibility criteria met