Accelerated Hypofractionated Radiotherapy in the Treatment of Malignant Pleural Mesothelioma
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.
• 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:
‣ 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.