New combo therapy for mesothelioma: radiation plus surgery under study
NCT ID NCT04028570
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is testing a new approach for people with malignant pleural mesothelioma, a rare lung cancer. It combines high-dose radiation (including a special boost to target bulky tumors) with surgery to remove the affected tissue. The main goal is to find the highest safe radiation dose that doesn't cause severe lung injury. Only 15 participants are enrolled, making this an early-stage feasibility study.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- radiation therapy (background and boost radiation)
- What this could lead to
- If successful, this could point toward a safer way to combine high-dose radiation with surgery for mesothelioma, potentially improving disease control.
- What could go wrong
- This is a very small, early feasibility study with only 15 participants, so results may not apply broadly. There is a risk of serious lung injury from the radiation.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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15 people
The number who actually took part.
- Started
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Sep 2019
- Expected to finish
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Apr 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Criteria: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Princess Margaret Hospital, University Health Network
Toronto, Ontario, M5G 2M9, Canada
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