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Pre-Surgery Radiation Therapy for Mesothelioma (SMARTER Trial)

N/A
Waitlist Available
Led By John Cho, MD, PhD
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Good pulmonary function precluding radiation therapy (FEV1>1 L or >40% predicted or DLCO >45% predicted)
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Must not have
Previous thoracic irradiation.
Poor performance status ECOG 3-4.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to five years
Awards & highlights

Summary

This trial will test different doses of radiation to find the maximum amount a patient can tolerate while still being effective in treating their cancer.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include skin reactions, fatigue, inflammation of lung tissue leading to coughing and difficulty breathing, as well as other risks typically associated with high-dose radiation therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My lung function is good enough that I can't have radiation therapy.
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I can take care of myself and am up and about more than half of my waking hours.
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I am 18 years old or older.
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My cancer is in an early to mid-stage and has not spread far.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had radiation therapy to the chest area before.
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I need help with my daily activities or am unable to do them.
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My lung function is too low for radiation therapy.
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I am under 18 years old.
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My cancer has spread to the lymph nodes on the opposite side of my chest.
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My cancer has spread to distant parts of my body.
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I do not have serious illnesses like heart or lung disease that would prevent me from receiving radiation treatment.
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I am not currently pregnant or breastfeeding.
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I have had chemotherapy for cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to five years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to five 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
Maximum Tolerated Dose for Background Radiation
Secondary study objectives
Evaluating patients' pain
Local recurrence
Patient Morbidity
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: RadiationExperimental Treatment1 Intervention
This study involves a 3+3 design. The starting cohort (n=3) will receive a neoadjuvant Background dose to the affected hemithorax (starting at 0 cGy) as well as concomitant Boost dose (of at least 2100 cGy) to a part of the gross tumour volume (GTV). The radiation will be delivered over 3 alternate days over 5-7 calendar days followed by macroscopically complete extensive pleural resection (either extra-pleural pneumonectomy or extended pleurectomy decortication, at the surgeon's discretion) after 7 to 14 days. If no dose limiting toxicities (DLTs) seen, then the Background RT dose will be increased by 600 cGy (up to 1800 cGy) and the cohort (n=3) for the next dose level will be accrued. If only 1 DLT seen, then an additional 3 patients will be treated on this dose level. If 2 or more DLTs seen at any given dose level, then the previous dose level will be defined as the maximum tolerated dose (MTD). Patients will be stratified by type of resection.

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,514 Previous Clinical Trials
500,193 Total Patients Enrolled
5 Trials studying Mesothelioma
1,597 Patients Enrolled for Mesothelioma
John Cho, MD, PhDPrincipal InvestigatorPrincess Margaret Hospital, Canada

Media Library

Background and Boost RT Clinical Trial Eligibility Overview. Trial Name: NCT04028570 — N/A
Mesothelioma Research Study Groups: Radiation
Mesothelioma Clinical Trial 2023: Background and Boost RT Highlights & Side Effects. Trial Name: NCT04028570 — N/A
Background and Boost RT 2023 Treatment Timeline for Medical Study. Trial Name: NCT04028570 — N/A
~1 spots leftby Apr 2025
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