Accelerated Hypofractionated Radiotherapy in the Treatment of Malignant Pleural Mesothelioma (MesoRT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03269227|
Recruitment Status : Recruiting
First Posted : August 31, 2017
Last Update Posted : November 9, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Malignant Pleural Mesothelioma||Radiation: Accelerated hypofractionation with Tomotherapy||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Accelerated Hypofractionated Radiotherapy in the Treatment of Malignant Pleural Mesothelioma|
|Actual Study Start Date :||August 14, 2017|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||July 2020|
Experimental: Accelerated hypofractionation with Tomotherapy
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 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] [ 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
- Overall survival (OS) [ Time Frame: up to 36 months ]time from randomization until death for any cause
- Disease control rate (DCR) [ Time Frame: up to 36 months ]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 to progessione (TTP) [ Time Frame: up to 36 months ]calculation of time to progression (TTP) for patients without evidence of disease or with not evaluable disease
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03269227
|Contact: Oriana Nanni||+39 0543 email@example.com|
|Meldola, Italy, 47014|
|Contact: Elisabetta Parisi, MD 0543 7391100 firstname.lastname@example.org|
|Study Director:||Elisabetta Parisi, MD||Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Via Maroncelli 40, 47014 Meldola, ITALY|