NCT03269227Active, not recruiting
Accelerated Hypofractionated Radiotherapy in the Treatment of Malignant Pleural Mesothelioma
Source: ClinicalTrials.gov · Last updated 16 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 30 (actual)
- First submitted
- 16 Aug 2017
- Start date
- 14 Aug 2017
- Primary completion date
- 24 Apr 2024
- Lead sponsor
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
- Diseases
- Mesothelioma, Lung cancer
- NCT number
- NCT03269227
What you commit to
- Study type: Interventional
- Participants enrolled: 30
- From 14 Aug 2017 to the primary completion date, 24 Apr 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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.
Age
- Age \>85 years old
Other
- Patients with M1 have to be excluded to this study
- FEV1 \< 50
- Interstitial pneumopathy
- Contralateral mediastinum involvement (N3) and M1
Who the study is looking for
- 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.
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| SC Radiotherapy Coordinator of this site? Confirm its status | Meldola | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.