Status:
ACTIVE_NOT_RECRUITING
A Feasibility Study Evaluating Surgery for Mesothelioma After Radiation Therapy Using Extensive Pleural Resection
Lead Sponsor:
University Health Network, Toronto
Conditions:
Mesothelioma; Lung
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 f...
Detailed 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 ther...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Good pulmonary function precluding radiation therapy (FEV1\>1 L or \>40% predicted or DLCO \>45% predicted)
- Any patient with a new histological diagnosis of malignant pleural mesothelioma (MPM). Sarcomatoid or biphasic histologies can be included but will be analyzed separately due to their poor prognosis.
- Stage T1-3 N0-1 M0 according to the 8th edition of the tumor, node, and metastases (TNM) staging system based on conventional investigations and tests (Appendix 1). Note that the updated TNM staging system now categorizes ipsilateral mediastinal nodes as N1 disease.
- Suitable for combined modality therapy
- Informed consent.
Exclusion
- Age \< 18 years.
- Contralateral mediastinal nodal disease (N2)
- Distant metastatic disease (M1).
- Poor performance status ECOG 3-4.
- Poor pulmonary function precluding radiation therapy (FEV1\<1 L or \<40% predicted or diffusion lung capacity for carbon monoxide (DLCO) \<45% predicted)
- Failure to provide informed consent.
- Previous thoracic irradiation.
- Serious non-malignant disease (e.g. cardiovascular, pulmonary, systemic lupus erythematosus (SLE), scleroderma) which would preclude definitive radiation treatment.
- Previous chemotherapy for this or concurrent malignancy.
- Previous or concomitant malignancies except for patients with non-melanoma skin cancer, contralateral non-invasive breast cancer, prostate cancer treated with curative intent or carcinoma in situ of any other site. In addition, patients with invasive cancers treated more than 3 years previously and without evidence of recurrence will be eligible.
- Women who are currently pregnant or lactating.
Key Trial Info
Start Date :
September 5 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2025
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04028570
Start Date
September 5 2019
End Date
April 1 2025
Last Update
July 15 2024
Active Locations (1)
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1
Princess Margaret Hospital, University Health Network
Toronto, Ontario, Canada, M5G 2M9