Last reviewed · How we verify
NCT04028570: SMARTER
A Feasibility Study Evaluating Surgery for Mesothelioma After Radiation Therapy Using Extensive Pleural Resection
NA trial testing Varying Doses of Background and Boost RT in Mesothelioma; Lung in 15 participants. Participants enrolled and being followed up; not accepting new ones.
1 April 2027
Quick facts
| Lead sponsor | University Health Network, Toronto |
|---|---|
| Phase | NA |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 15 |
| Start date | 5 September 2019 |
| Primary completion | 1 April 2027 |
| Estimated completion | 1 April 2027 |
| Sites | 1 location across Canada |
Drugs / interventions tested
- Varying Doses of Background and Boost RT
Conditions studied
- Mesothelioma; Lung — all drugs for Mesothelioma; Lung →
Sponsor
University Health Network, Toronto
Who can join
18 and older, any sex, with Mesothelioma; Lung. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Maximum Tolerated Dose for Background Radiation
Time frame: Up to five years
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+).
Sponsor's own description
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.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Malignant mesothelioma tumours: molecular pathogenesis, diagnosis, and therapies accompanying clinical studies.
Sahu RK, Ruhi S, Jeppu AK, Al-Goshae HA, et al · · 2023 · cited 21× · PMID 37469419 · DOI 10.3389/fonc.2023.1204722 -
Contemporary issues in the surgical management of pleural mesothelioma.
Paajanen J, Jaklitsch MT, Bueno R. · · 2023 · cited 5× · PMID 36630097 · DOI 10.1002/jso.27152 -
Perioperative Treatments in Pleural Mesothelioma: State of the Art and Future Directions.
Cecchi LG, Aliprandi M, De Vincenzo F, Perrino M, et al · · 2025 · cited 3× · PMID 41097726 · DOI 10.3390/cancers17193199 -
Surgery for Mesothelioma After Radiation Therapy (SMART); A Single Institution Experience.
Breen WG, Garces YI, Olivier KR, Park SS, et al · · 2020 · cited 1× · PMID 32266156 · DOI 10.3389/fonc.2020.00392
Verify or expand the search:
- PubMed search for NCT04028570
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Mesothelioma; Lung
Currently open trials in the same condition.
- NCT07126509 — Partial Pleurectomy (Surgery) for Unresectable Pleural Mesothelioma · NA · recruiting
- NCT06581549 — Immune Microenvironment and Gene Expression Profiling in Mesothelioma · recruiting
- NCT04300244 — Nivolumab and Ipilimumab +/- UV1 Vaccination as Second Line Treatment in Patients With Malignant Mesothelioma · Phase 2 · active not recruiting
Other University Health Network, Toronto trials
Trials by the same sponsor.
- NCT06831032 — Elective Adaptive Radiation With SBRT for Improved DurabilitY of Response · NA · recruiting
- NCT06634056 — Pneumonitis Prevention Protocol Using Pentoxifylline and α-tocopherol In Stage III Non-Small Cell Lung Cancer Patients U · Phase 2 · not yet recruiting
- NCT06836726 — Clinical Trial to Test Efficacy of Targeting Hypoxia Combined With ARSI After First-line ARSI Therapy for Castrate Resis · Phase 2 · not yet recruiting
- NCT07515651 — Molecular Imaging Informed Radiation Dose Escalation to Sites of Recurrent Disease and De-escalation to Uninvolved Areas · Phase 2 · not yet recruiting
- NCT07509450 — Fecal Microbiota Transplantation in Patients Undergoing Chimeric Antigen Receptor T-cell Therapy and Allogeneic Stem Cel · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04028570 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Health Network, Toronto
- Last refreshed: 3 March 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04028570.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing