New radiation approach shows promise for mesothelioma patients
NCT ID NCT03269227
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new way to give radiation therapy to people with malignant pleural mesothelioma, a rare and serious lung cancer. The treatment uses a special machine called Tomotherapy to deliver high doses of radiation over just 5 days. The goal is to see if this short, intense treatment is safe and helps control the disease after surgery. The study includes 30 adults aged 18 to 85 with good overall health.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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30 people
The number who actually took part.
- Started
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Aug 2017
- Expected to finish
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Nov 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 85 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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SC Radiotherapy
Meldola, 47014, Italy
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Other studies related to the condition(s) this trial covers.
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