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Radiation Therapy
Adaptive Radiation Dose Escalation for Non-Small Cell Lung Cancer (PET-BOOST Trial)
N/A
Waitlist Available
Research Sponsored by Lawson Health Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients who are at least 18 years old and are able to consent
Patients who will undergo Chemo-RT as primarily modality of treatment
Must not have
Active invasive malignancy other than lung cancer
Previous radiotherapy to intended treatment volumes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Summary
This trial is testing whether a higher dose of radiation to areas of the tumor that are more active will reduce the rate of the cancer coming back in 2 years.
Who is the study for?
Adults with locally advanced non-small cell lung cancer who can undergo chemoradiotherapy, have a certain level of physical fitness (ECOG status 0-2), and tumors visible on scans. Excluded are those with poor respiratory function, significant recent weight loss, inadequate bone marrow reserve, other active cancers, severe heart or lung conditions, liver issues, pregnancy, or AIDS.
What is being tested?
This phase II trial is testing if increasing the radiation dose to parts of the tumor that show more activity on PET scans can lower the chance of cancer returning within two years. Patients will either receive standard chemoradiotherapy or an intensified version targeting these active tumor areas.
What are the potential side effects?
Chemoradiotherapy may cause side effects like fatigue, skin irritation at the treatment site, nausea and vomiting. The higher radiation doses could potentially increase these effects and might also lead to more serious complications in nearby organs.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years or older and can give my consent.
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I will be treated with both chemotherapy and radiation as my main treatment.
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My tumor or lymph node is at least 10mm large as shown on a CT scan.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have another active cancer besides lung cancer.
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I have had radiotherapy in the areas where I now need treatment.
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I had surgery as part of my cancer treatment plan.
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I do not have severe heart issues, recent serious infections, severe lung problems, or AIDS.
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My lung function is significantly below normal.
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My recent blood tests show low white blood cells, platelets, or hemoglobin.
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I have lost more than 10% of my weight without trying over the last 3 months.
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I need assistance with my daily activities.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Reduction of local-regional failure rate
Secondary study objectives
Dose Escalation Feasibility
Dose-Response Characterization
Grade 3-5 Toxicity Rate
+5 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Chemoradiotherapy with Integrated Boost DoseExperimental Treatment1 Intervention
Patients randomized to the experimental arm will receive radiotherapy (5x per week) with an integrated boost dose of up to 85Gy in 30 fractions to tumor subvolumes, with concurrent cisplatin and etoposide chemotherapy.
Group II: ChemoradiotherapyActive Control1 Intervention
Patients randomized to the standard arm will receive radiotherapy (5x per week) of 60 gray (Gy) in 30 fractions with concurrent cisplatin and etoposide chemotherapy.
Find a Location
Who is running the clinical trial?
Lawson Health Research InstituteLead Sponsor
672 Previous Clinical Trials
414,433 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have another active cancer besides lung cancer.I have had radiotherapy in the areas where I now need treatment.I had surgery as part of my cancer treatment plan.I can care for myself and am up and about more than 50% of my waking hours.Your liver function tests show that AST, ALT, or total bilirubin levels are more than 2.5 times higher than the normal range.I am 18 years or older and can give my consent.I do not have severe heart issues, recent serious infections, severe lung problems, or AIDS.I will be treated with both chemotherapy and radiation as my main treatment.My tumor or lymph node is at least 10mm large as shown on a CT scan.You are currently pregnant.My lung function is significantly below normal.My recent blood tests show low white blood cells, platelets, or hemoglobin.I have lost more than 10% of my weight without trying over the last 3 months.I need assistance with my daily activities.You have a tumor that shows high uptake of a special imaging substance called FDG on a PET scan.
Research Study Groups:
This trial has the following groups:- Group 1: Chemoradiotherapy
- Group 2: Chemoradiotherapy with Integrated Boost Dose
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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