Clinical Trials Logo
  1. Home
  2. Mesothelioma; Lung
  3. NCT04028570

A Feasibility Study Evaluating Surgery for Mesothelioma After Radiation Therapy Using Extensive Pleural Resection — SMARTER  

Mesothelioma; Lung Clinical Trial

Official title:
A Feasibility Study Evaluating Surgery for Mesothelioma After Radiation Therapy Using Extensive Pleural Resection

Clinical Trial Summary

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.

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04028570
Study type Interventional
Source University Health Network, Toronto
Contact
Status Active, not recruiting
Phase N/A
Start date September 5, 2019
Completion date April 2025
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05005429 - Study of the Efficacy and Safety of the Bintrafusp Alfa in Previously Treated Advanced Malignant Pleural Mesothelioma Phase 2
Not yet recruiting NCT06310993 - Exercise to Boost Immunity in Advanced Cancer N/A
Recruiting NCT04981119 - Solid Tumor Analysis for HLA Loss of Heterozygosity (LOH) and Apheresis for CAR T- Cell Manufacturing
Active, not recruiting NCT04300244 - Nivolumab and Ipilimumab +/- UV1 Vaccination as Second Line Treatment in Patients With Malignant Mesothelioma Phase 2
Recruiting NCT05278975 - Study of RSO-021 in Patients With Malignant Pleural Effusion Due to Advanced/Metastatic Solid Tumors Including Mesothelioma Phase 1/Phase 2
Not yet recruiting NCT04804410 - Dielectric Properties of Matched Tissue Samples From Thoracic Malignancies and Corresponding Normal Tissues N/A
Recruiting NCT04214015 - A Pilot Study to Explore the Role of Gut Flora in Metastatic Mesothelioma
Completed NCT05404022 - Feasibility Trial of a Personalised Nutrition and Activity Programme for People With Lung Cancer Over 65 Years N/A
Recruiting NCT05228795 - Glypican-1 Expression in Epithelioid Mesothelioma, Adenocarcinoma and SCC of the Lung