Clinical trial · Interventional
Accelerated Hypofractionated Radiotherapy in the Treatment of Malignant Pleural Mesothelioma
NCT03269227CI-TRIAL-00101018MesoRTactive not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Pleural Mesothelioma | Pleural Malignant Mesothelioma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Accelerated hypofractionation with Tomotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Accelerated hypofractionation with Tomotherapy
- description
- 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).
- interventionNames
- Radiation: Accelerated hypofractionation with Tomotherapy
Primary outcomes (1)
- measure
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
- timeFrame
- up to 36 months
- description
- 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
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients must have histologically or cytologically confirmed MPM 2. Karnofsky Performance status scale 70-100 (see Appendix B) 3. Male or female, Aged \>= 18 and ≤ 85 years 4. Life expectancy greater than 6 months 5. All clinical and pathological stage with the exclusion of contralateral mediastinum involvement (N3) and M1 6. 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 7. Ability to understand and the willingness to sign a written informed consent document. 8. Forced expiratory volume in the 1st second(FEV1) ≥ 50 9. 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. 10. Written informed consent signed and dated before starting study procedure. 11. 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. Exclusion Criteria: 1. Previous thorax radiotherapy 2. Chemotherapy is allowed but completed 3 weeks before RT starts 3. Participation in another clinical trial with any investigational agents within 30 days prior to study screening. 4. Patients with M1 have to be excluded to this study 5. FEV1 \< 50 6. Age \>85 years old 7. Respiratory needing oxygen therapy 8. Interstitial pneumopathy 9. Active pneumonitis 10. Fissural disease 11. Contralateral mediastinum involvement (N3) and M1 12. 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.
References
Publications (0)
Data not yet available
No reference posted for this study.