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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
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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:Select...
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
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 moreTrial 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
1,628 Previous Clinical Trials
3,325,309 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am considered fit for lung surgery that is not a wedge resection.I have had cancer before, but it wasn't follicular lymphoma, chronic lymphocytic leukemia, or hormone-sensitive prostate cancer.I am a woman under 61 or haven't had a hysterectomy and my pregnancy test is positive.I am 18 years old or older.I have or am suspected to have early-stage lung cancer.I am willing and able to agree to participate in the study.My tumor is at least 1cm away from critical areas like the windpipe or spinal cord.My cancer has spread to my lymph nodes or other parts of my body.My lung cancer diagnosis was confirmed through a biopsy.My case has been reviewed by a team of different healthcare specialists.My tumor is 5cm or smaller, based on my latest scans.My lymph nodes larger than 10mm with high activity were checked.I must have a biopsy if there are suspicious lesions on my PET/CT scan.My cancer has spread to my lymph nodes or other parts of my body.My primary tumor is 5 cm or smaller, confirmed by a CT scan.I have been diagnosed with stage IV cancer.I have a history of scleroderma.I have had lung cancer before, but not including my current condition.A radiation oncologist has approved me for a specific type of targeted radiotherapy.I had cancer treatment within the last 2 years, but not for low-risk cancers.Your lung function tests show that you can breathe out at least 40% of what is expected and your lungs can transfer oxygen at least 40% as expected.A thoracic surgeon has deemed me inoperable.I am able to care for myself but may not be able to do active work.I had a PET/CT scan within the last 60 days.I have had surgery for lung, esophageal cancer, or heart surgery before.I am willing to be assigned to a treatment group by chance.I have had radiation therapy to my chest area before.
Research Study Groups:
This trial has the following groups:- Group 1: Stereotactic radiotherapy
- Group 2: Surgery
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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