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.
This study aims to find the maximum tolerated dose level for mesothelioma patients receiving background radiation + boost radiation, and surgery. 3 patients will start with a background radiation therapy (RT) dose of 0 cGy, and boost RT of at least 2100 cGy. If the radiation is manageable (radiation related AEs grade \< 4), the next set of 3 patients will be enrolled, and the background radiation dose will be increased by 600 cGy. This will continue until the background radiation dose reaches 1800 cGy. If 1 patient exhibits dose limiting toxicities (AEs grade 4 \& 5), the dose level will repeat with the next 3 patients. If 2 or more patients exhibit DLTs, the previous dose level will be determined as the maximum tolerated dose level. Surgery will be scheduled to occur approximately 1-2 weeks after completing radiation therapy, and will subsequently be followed up as per study schedule.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
3+3 radiation dose escalation model to see the maximum tolerated dose for background and boost radiation therapy.
Princess Margaret Hospital, University Health Network
Toronto, Ontario, Canada
Maximum Tolerated Dose for Background Radiation
AEs will be graded by CTCAE. Maximum tolerated dose is the dose level that do not result in fatal lung injury (grade 5 lung toxicity) or life-threatening or fatal treatment related toxicity (grade 4+).
Time frame: Up to five years
Patient Morbidity
NCI common toxicity scale
Time frame: Up to five years
Local recurrence
Documented radiographically
Time frame: Up to five years
Patients' quality of life
Short Form Health Survey-36 (SF-36) Form
Time frame: Up to five years
Evaluating patients' pain
Assess by using the Short Form (BPI-SF)
Time frame: Up to five years
Evaluating patients' pain
Assess by using The Hospital Anxiety and Depression Scale (HADS)
Time frame: Up to five years
Evaluating patients' pain
Assess by using the EuroQol EQ-5D-5L Questionnaire
Time frame: Up to five years
Evaluating patients' pain
Assess by using the Sensitivity to Pain Traumatization Scale (SPTS)
Time frame: Up to five years
Evaluating patients' pain
Assess by using the ID Pain form
Time frame: Up to five years
Evaluating patients' pain
Assess by using the Pain Catastrophizing Scale (PCS)
Time frame: Up to five years
Evaluating patients' pain
Assess by using the Post-traumatic Stress Disorder Checklist-Civilian version (PCL-C)
Time frame: Up to five years
Evaluating patients' pain
Assess by using a variety of standard instruments including the Injustice Experience Questionnaire (IEQ).
Time frame: Up to five years
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