Malignant Pleural MesotheliomaMesoRTNCT03269227
Accelerated Hypofractionated Radiotherapy in the Treatment of Malignant Pleural Mesothelioma
A study testing Accelerated hypofractionation with Tomotherapy in people with Malignant Pleural Mesothelioma, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Malignant Pleural Mesothelioma
- What is being tested?
- Accelerated hypofractionation with Tomotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 14 Aug 2017to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have histologically or cytologically confirmed MPM
- Karnofsky Performance status scale 70-100 (see Appendix B)
- Male or female, Aged >= 18 and ≤ 85 years
- Life expectancy greater than 6 months
- All clinical and pathological stage with the exclusion of contralateral mediastinum involvement (N3) and M1
- Patients must have normal organ and marrow function as defined below:
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- leukocytes >3,000/microL
- absolute neutrophil count >1,500/microL
- platelets >100,000/microL
- aspartate transaminase(AST)/alanine transaminase (ALT) <2.5 X institutional upper limit of normal
- creatinine within normal institutional limits
- glycemia < 100 mg/dl
- Ability to understand and the willingness to sign a written informed consent document.
- Forced expiratory volume in the 1st second(FEV1) ≥ 50
- Patients after biopsy must have measurable disease defined as at least one lesion that can be accurately measured according to modified RECIST criteria; for resected patients no more than 3 months are allowed for RT start.
- Written informed consent signed and dated before starting study procedure.
- Female participants of child bearing potential and male participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study and for 4 months thereafter.
Who cannot join
- Previous thorax radiotherapy
- Chemotherapy is allowed but completed 3 weeks before RT starts
- Participation in another clinical trial with any investigational agents within 30 days prior to study screening.
- Patients with M1 have to be excluded to this study
- FEV1 < 50
- Age >85 years old
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- Respiratory needing oxygen therapy
- Interstitial pneumopathy
- Active pneumonitis
- Fissural disease
- Contralateral mediastinum involvement (N3) and M1
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Conditions
- Malignant Pleural Mesothelioma
- Being tested
- Accelerated hypofractionation with Tomotherapy
- Keywords
- Malignant Pleural Mesothelioma, Radiotherapy, Tomotherapy, Hypofractionation
- Medical subject headings
- Mesothelioma, Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Accelerated hypofractionation with TomotherapyRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| Accelerated hypofractionation with Tomotherapy | Experimental | 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). Receives: Radiation: Accelerated hypofractionation with Tomotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 36 months
Secondary outcomes (3)
Overall survival (OS)
time from randomization until death for any cause
Measured: 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
Measured: 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
Measured: up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2017
- Study start14 Aug 2017
- Primary completion24 Apr 2024
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Pleural MesotheliomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elisabetta Parisi, MD, Study director, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Via Maroncelli 40, 47014 Meldola, ITALY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03269227
- Sponsor's protocol ID
- IRST163.01
- Acronym
- MesoRT
- Status last verified
- Jan 2026
- First submitted
- 16 Aug 2017
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accelerated Hypofractionated Radiotherapy in the Treatment of Malignant Pleural Mesothelioma
- ClinicalTrials.gov ID
- NCT03269227
- Acronym / sponsor ID
- MesoRT / IRST163.01
- Conditions
- Malignant Pleural Mesothelioma
- Keywords
- Malignant Pleural Mesothelioma, Radiotherapy, Tomotherapy, Hypofractionation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCSUniversity, hospital or other
- Study start
- 14 Aug 2017 (actual)
- Primary completion
- 24 Apr 2024 (actual)
- Study completion
- Nov 2026 (estimated)
- First posted
- 31 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Accelerated hypofractionation with Tomotherapy | Experimental | Radiation: Accelerated hypofractionation with TomotherapyTomotherapy 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). |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Patients must have histologically or cytologically confirmed MPM
- Karnofsky Performance status scale 70-100 (see Appendix B)
- Male or female, Aged >= 18 and ≤ 85 years
- Life expectancy greater than 6 months
- All clinical and pathological stage with the exclusion of contralateral mediastinum involvement (N3) and M1
Key exclusion criteria (12 listed)
- Previous thorax radiotherapy
- Chemotherapy is allowed but completed 3 weeks before RT starts
- Participation in another clinical trial with any investigational agents within 30 days prior to study screening.
- Patients with M1 have to be excluded to this study
- FEV1 < 50
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Accelerated hypofractionation with TomotherapyTomotherapy 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. | Radiation | Accelerated hypofractionation with Tomotherapy |
Primary outcome
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: up to 36 months
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
3 secondary outcomes
Overall survival (OS)
Time frame: up to 36 months
Disease control rate (DCR)
Time frame: up to 36 months
time to progessione (TTP)
Time frame: up to 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elisabetta Parisi, MD study director
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Via Maroncelli 40, 47014 Meldola, ITALY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Accelerated hypofractionation with Tomotherapy in people with Malignant Pleural Mesothelioma, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (time frame: up to 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.