Adaptive Radiation Dose Escalation for Non-Small Cell Lung Cancer

(PET-BOOST Trial)

Recruiting at 6 trial locations

Overseen By David Palma, MD, FRCPC

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Disqualifiers: Uncontrolled cardiac disease, COPD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 6 weeks

78 Participants Needed

Trial Summary

What is the purpose of this trial?

A randomized phase II trial to assess the efficacy and safety of selective metabolically adaptive radiation dose escalation in locally advanced non-small cell lung cancer receiving definitive chemoradiotherapy. Eligible and consenting patients will be randomized to receive conventional chemoradiotherapy or chemoradiotherapy with a radiation (RT) integrated boost. All patients will receive a fludeoxyglucose-positron emission tomography (FDG-PET) scan within two weeks prior to starting treatment. The primary outcome is to determine if dose escalation to metabolically active tumor subvolumes will reduce local-regional failure rate at 2 years.

Eligibility Criteria

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.

Inclusion Criteria

I can care for myself and am up and about more than 50% of my waking hours.

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.

Exclusion 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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Treatment

Participants receive chemoradiotherapy with or without an integrated boost dose, including concurrent cisplatin and etoposide chemotherapy

6 weeks

5 visits per week (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of local-regional failure rate and quality of life

2 years

Regular visits (frequency not specified)

Treatment Details

Interventions

• Chemoradiotherapy
• Chemoradiotherapy with Integrated Boost Dose

Trial Overview 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.

Participant Groups

Group I: Chemoradiotherapy with Integrated Boost Dose Experimental Treatment 1 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: Chemoradiotherapy Active Control 1 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.

Who Is Running the Clinical Trial?

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

678

Recruited

421,000+

London Health Sciences Centre OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

668

Recruited

424,000+

London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

686

Recruited

427,000+

Lawson Health Research Institute

Lead Sponsor

Trials

684

Recruited

432,000+