Accelerated Hypofractionated Radiotherapy in the Treatment of Malignant Pleural Mesothelioma

Phase

N/A

Condition

Mesothelioma

Lung Cancer

Treatment

Accelerated hypofractionation with Tomotherapy

Clinical Study ID

NCT03269227

IRST163.01

Ages 18-85
All Genders

Study 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.

The treatment will be delivered using Tomotherapy, that allows to adopt dose accelerated hypofraction criteria. Treatment duration is 5 consecutive days.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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 mediastinuminvolvement (N3) and M1
Patients must have normal organ and marrow function as defined below:

leukocytes >3,000/microL
absolute neutrophil count >1,500/microL
platelets >100,000/microL
aspartate transaminase(AST)/alanine transaminase (ALT) <2.5 X institutionalupper limit of normal
creatinine within normal institutional limits
glycemia < 100 mg/dl

Ability to understand and the willingness to sign a written informed consentdocument.
Forced expiratory volume in the 1st second(FEV1) ≥ 50
Patients after biopsy must have measurable disease defined as at least one lesionthat can be accurately measured according to modified RECIST criteria; for resectedpatients 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 partneris of child bearing potential must be willing to ensure that they or their partneruse effective contraception during the study and for 4 months thereafter.

Exclusion

Exclusion Criteria:

Previous thorax radiotherapy
Chemotherapy is allowed but completed 3 weeks before RT starts
Participation in another clinical trial with any investigational agents within 30days prior to study screening.
Patients with M1 have to be excluded to this study
FEV1 < 50
Age >85 years old
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 activeinfection, symptomatic congestive heart failure, unstable angina pectoris, cardiacarrhythmia, or psychiatric illness/social situations that would limit compliancewith study requirements.

Study Design

Accelerated hypofractionation with Tomotherapy

August 14, 2017

November 30, 2026

Study 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.

Connect with a study center

SC Radiotherapy
Meldola, 47014
Italy
Site Not Available
SC Radiotherapy
Meldola 3173635, 47014
Italy
Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.