12 Participants Needed

Pre-Surgery Radiation Therapy for Mesothelioma

(SMARTER Trial)

JC
Overseen ByJohn Cho, MD, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University Health Network, Toronto
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This study aims to find the maximum tolerated dose level for malignant pleural mesothelioma patients receiving background radiation + boost radiation, and surgery. Boost radiation is an experimental form of radiation that involves targeting non-uniform high doses of radiation to bulky pleural masses. We hypothesize the immunologic abscopal effect is an important component in controlling disease, and may be stimulated with highly hypofractionated doses. Doses will increase with every three patients who will be enrolled in the study until the background radiation reaches 1800 cGy or the maximum tolerated dose, whichever is lower.

Who Is on the Research Team?

JC

John Cho, MD

Principal Investigator

Princess Margaret Hospital, Canada

Are You a Good Fit for This Trial?

Adults over 18 with early-stage malignant pleural mesothelioma, good lung function, and performance status. They must be new diagnoses without prior thoracic radiation or chemotherapy for this cancer or others within the last 3 years (except certain non-invasive cancers). Pregnant women are excluded.

Inclusion Criteria

My lung function is good enough that I can't have radiation therapy.
I can take care of myself and am up and about more than half of my waking hours.
I am eligible for treatment that combines different methods.
See 3 more

Exclusion Criteria

I have had radiation therapy to the chest area before.
I have had cancer before, but it was either non-melanoma skin cancer, non-invasive breast cancer, prostate cancer treated to cure, or any cancer treated over 3 years ago without recurrence.
I need help with my daily activities or am unable to do them.
See 8 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive background and boost radiation therapy to determine the maximum tolerated dose

5-7 days
3 visits (in-person)

Surgery

Surgery is performed approximately 1-2 weeks after completing radiation therapy

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety, effectiveness, and quality of life after treatment

Up to five years

What Are the Treatments Tested in This Trial?

Interventions

  • Background and Boost RT
  • Surgery for Mesothelioma
Trial Overview The study is testing how much radiation can be safely given to mesothelioma patients before surgery. It involves increasing doses of background plus boost radiation until reaching a maximum safe level or a set dose limit.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: RadiationExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials
1,555
Recruited
526,000+
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