RecruitingNot ApplicableNCT04822077

Study on Proton Radiotherapy of Thymic Malignancies

PROTHYM - Phase II Non-randomized Study on Proton Radiotherapy Of Thymic Malignancies


Sponsor

Ass. Prof. Jan Nyman

Enrollment

40 participants

Start Date

Apr 18, 2018

Study Type

INTERVENTIONAL

Conditions

Summary

This is a multicentre non-randomized phase II study of proton beam radiotherapy in patients with thymic epithelial tumours (i.e. thymoma and thymic carcinoma) in the post-operative setting or in inoperable patients with localized disease. Patients not willing or for any reason unsuitable to undergo proton treatment will be asked to participate in a follow-up assessment after the regular photon treatment in the same manner as the included patients. Primary endpoints are:Toxicity (e.g. cardiac and pulmonary toxicity) and Local control at 5 year Secondary endpoints: PFS, Overall survival, Quality of life, measured by EORTC QLQ 30 + LC 13 and relapse pattern


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is examining whether proton beam radiation therapy — a precise type of radiation that targets tumors while sparing surrounding healthy tissue — is safe and effective for treating rare cancers of the thymus (a gland in the chest). It includes patients who had surgery and those who did not. **You may be eligible if...** - You have been diagnosed with thymoma or thymic carcinoma (confirmed by biopsy) - You had surgery but your cancer was advanced (stage II–IVa) or your surgeon could not remove all the cancer - You could not or chose not to have surgery (any stage I–IVa) - You are 18 years or older - Your lung function is adequate **You may NOT be eligible if...** - Your cancer has spread to distant organs (stage IVb) - You are pregnant - You have another serious illness that would make treatment unsafe - Your tumor moves significantly with breathing (making precise radiation difficult) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONProton radiation

* Patients with radical surgery and unfavourable histology (B2, B3, C) and/or Masaoka-Koga stage III, IVa: 2 Gy(RBE), once daily, five days a week to a total dose of 50 Gy(RBE). * Patients with non-radical surgery (R1 resection) regardless of stage and histology: 2.3 Gy(RBE), once daily, 5 days a week to a total dose of 57.5 Gy(RBE) * Inoperable patients regardless of stage and histology and patients with R2 non-radical resection: 2.5 Gy (RBE), once daily, 5 days a week to a total dose of 62.5 Gy(RBE)


Locations(3)

Department of Oncology, Norrlands Universitetssjukhus

Umeå, Norrland, Sweden

Department of Oncology, Karolinska University Hospital

Stockholm, Stockholm County, Sweden

Department of Oncology, Sahlgrenska University Hospital

Gothenburg, Västra Götaland County, Sweden

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NCT04822077


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