Accelerated Hypofractionated Radiotherapy in the Treatment of Malignant Pleural Mesothelioma

Korábbi kezelés

• 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.
• Respiratory needing oxygen therapy

Más betegség

• Active pneumonitis
• Fissural disease
• 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.

Életkor

• Age \>85 years old

Egyéb

• Patients with M1 have to be excluded to this study
• FEV1 \< 50
• Interstitial pneumopathy
• Contralateral mediastinum involvement (N3) and M1

• 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.