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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

No Placebo-Only Group

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 below

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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:

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 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

Reduction of local-regional failure rate

Secondary study objectives

Dose Escalation Feasibility

Dose-Response Characterization

Grade 3-5 Toxicity Rate

+5 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: 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.

0 / 11Eligibility criteria met