NCT04028570Active, not recruiting
A Feasibility Study Evaluating Surgery for Mesothelioma After Radiation Therapy Using Extensive Pleural Resection
Source: ClinicalTrials.gov · Last updated 5 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 15 (actual)
- First submitted
- 3 Apr 2019
- Start date
- 5 Sept 2019
- Primary completion date
- 30 Apr 2027
- Lead sponsor
- University Health Network, Toronto
- Diseases
- Mesothelioma, Lung cancer
- NCT number
- NCT04028570
What you commit to
- Study type: Interventional
- Participants enrolled: 15
- From 5 Sept 2019 to the primary completion date, 30 Apr 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Poor pulmonary function precluding radiation therapy (FEV1\<1 L or \<40% predicted or diffusion lung capacity for carbon monoxide (DLCO) \<45% predicted)
- Previous thoracic irradiation.
- 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.
Other illness
- Contralateral mediastinal nodal disease (N2)
- Distant metastatic disease (M1).
- Failure to provide informed consent.
- Serious non-malignant disease (e.g. cardiovascular, pulmonary, systemic lupus erythematosus (SLE), scleroderma) which would preclude definitive radiation treatment.
Age
- Age \< 18 years.
Other
- Poor performance status ECOG 3-4.
- Women who are currently pregnant or lactating.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Princess Margaret Hospital, University Health Network Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.