An interventional study of Accelerated hypofractionation with Tomotherapy in Malignant Pleural Mesothelioma, sponsored by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS. Active, not recruiting at 1 site in Italy. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-01-16.
Sponsored by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS · Not applicable, Interventional, and Treatment
This is a monocentric prospective study of radiotherapy using accelerated hypofractionation with Tomotherapy in Malignant Pleural Mesothelioma (MPM) patients after pleurectomy / decortication (P / D) or biopsy.
The treatment will be delivered using Tomotherapy, that allows to adopt dose accelerated hypofraction criteria. Treatment duration is 5 consecutive days.
The role of radiation therapy remains to be defined in unresected MPM or after P/D. For the latter, local control remains the primary objective but radiotherapy (RT) is a challenge because of the risk of pneumonia in the intact lung. There are no specific clinical data to support the use of adjuvant radiation therapy after P/D or definitive radiation therapy after biopsy-based diagnosis for patients not amenable to surgery.
However, recent publications on Intensity Modulated Radiotherapy (IMRT) and conventional fractionation after P/D or biopsy have shown the feasibility and acceptable toxicity profile of the treatment.
The investigators submitted a retrospective analysis of accelerated hypofractionated Intensity modulated arc therapy (IMAT) using TomoTherapy in MPM following P/D or diagnostic biopsy. In the investigators experience of MPM, treatment of the intact lung with pleural IMAT using helical Tomotherapy is a safe and feasible option with an acceptable lung toxicity profile. The results obtained in terms of toxicity were encouraging. In fact, the investigators only observed one case of G3 pneumonia, and the patient in question is still alive and off oxygen therapy. Patient compliance with this short-course treatment was also very good.
Overall, the investigators found that accelerated hypofractionation with IMAT was feasible at the dose delivered and had an acceptable toxicity profile. So the investigators want to propose this protocol for treatment of MPM in intact lung to improve local control.
In patients with malignant pleural mesothelioma who underwent pleurectomy / decortications (P/D) or only diagnostic biopsy, it is difficult to deliver a tumoricidal dose of radiation to the pleura due to the presence of the ipsilateral lung. In recent years, the investigators have implemented a technique for irradiation of the pleura in intact lung, using accelerated hypofractionation with Tomotherapy in an attempt to reduce as far as possible, the dose to the ipsilateral lung. The aim of the treatment was palliation. The investigators analyzed the data of 36 patients with MPM, with a long follow-up without recording death cases related to radiation treatment or radiation pneumonitis grade 4.
In view of these data, the aim of this study is to increase the dose of treatment in patients suffering from MPM after P/D or biopsy.
The study will evaluate the feasibility of the treatment through the study of pulmonary acute and late toxicity; The treatment will be delivered using Tomotherapy that allows to adopt dose accelerated hypofraction criteria. Treatment duration is 5 consecutive days.
Patients must have normal organ and marrow function as defined below:
Exclusion Criteria:
Tomotherapy Treatment Planning System (TPS) will be used for treatment plannings. Patient' set-up daily control through Tomo-image (CT megavoltage) immediately before each sitting of all the patients. Prescription dose to the target: 30 Gy in 5 daily fraction (at the reference isodose 60-70%) with an internal increasing inhomogenous dose of up to 37.5 Gy-40 Gy for Gross Tumor Volume (GTV).
Radiation: Accelerated hypofractionation with Tomotherapy
Tomotherapy TPS will be used for treatment plannings. Patient' set-up daily control through Tomo-image (CT megavoltage) immediately before each sitting of all the patients. Prescription doses: Prescription dose to the target: 30 Gy in 5 daily fraction (at the reference isodose 60-70%) with an internal increasing inhomogenous dose of up to 37.5 Gy-40 Gy for GTV. Steroids (methylprednisolone 4 mg daily) should be used from day 1 of radiotherapy to day + 30 after the end of the treatment.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Acute and late toxicity evaluation by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03, performing strumental tests (CT scan, spirometry) to evaluate adverse events including pulmonary toxicity
Time frame: up to 36 months
Overall survival (OS)
time from randomization until death for any cause
Time frame: up to 36 months
Disease control rate (DCR)
the assessment of disease control rate (DCR) defined as proportion of patients with complete response (CR), partial response (PR) and stable disease (SD) for patients with evaluable disease using the Modified RECIST criteria for assessment of response in malignant pleural mesotelioma
Time frame: up to 36 months
time to progessione (TTP)
calculation of time to progression (TTP) for patients without evidence of disease or with not evaluable disease
Time frame: up to 36 months
Plan to share: Undecided
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS