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New radiation approach shows promise for mesothelioma patients

NCT ID NCT03269227

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

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

30 people

The number who actually took part.

Started

Aug 2017

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

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

18 to 85 years

Sex

Anyone

Healthy volunteers

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

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.

malignant pleural mesothelioma Mesothelioma, Malignant

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • SC Radiotherapy

    Meldola, 47014, Italy

More trials for these conditions

Other studies related to the condition(s) this trial covers.