Accelerated Hypofractionated Radiotherapy in the Treatment of Malignant Pleural Mesothelioma

NCT03269227 | Active Not Recruiting

• 1 other identifier: IRST163.01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Malignant Pleural Mesothelioma

Keywords

Malignant Pleural Mesothelioma; Radiotherapy; Tomotherapy; Hypofractionation

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  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

  up to 36 months

Secondary Outcomes (3)

• Overall survival (OS)

  up to 36 months

• Disease control rate (DCR)

  up to 36 months

• time to progessione (TTP)

  up to 36 months

Study Arms (1)

Accelerated hypofractionation with Tomotherapy

EXPERIMENTAL

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

Interventions

Accelerated hypofractionation with Tomotherapy RADIATION

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 doses: 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.

Accelerated hypofractionation with Tomotherapy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.
• 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 active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Sponsors & Collaborators

• Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS: lead

Study Sites (1)

SC Radiotherapy

Meldola, 47014, Italy

Location

MeSH Terms

Conditions

Mesothelioma, Malignant

Interventions

Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Mesothelioma; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Mesothelial; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Pleural Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Study Officials

• Elisabetta Parisi, MD

  Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Via Maroncelli 40, 47014 Meldola, ITALY

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2017
• First Posted: August 31, 2017
• Study Start: August 14, 2017
• Primary Completion: April 24, 2024
• Study Completion (Estimated): November 1, 2026
• Last Updated: January 16, 2026

Record last verified: 2026-01

Locations

IT (1)