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Study on Proton Radiotherapy of Thymic Malignancies

RecruitingNAAges 18 Years - anyAllAss. Prof. Jan Nyman
NCT04822077 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: * Histological or cytological diagnosis of thymoma or thymic carcinoma. * With radical surgery: stage III and IVa and selected stage II with type B2, B3 and thymic carcinoma according to local routine. With non-radical surgery (R1 or R2) or inoperable patient/ patient refusing surgery: stage I - IVa, any histology * PS WHO 0 - 2. * FEV1 \> 1L or \>40 % of predicted and CO diffusion capacity \> 40% of predicted (postoperative measures) * Age \>18 years, no upper age limit. * Written informed consent from patients. Exclusion Criteria: * Masaoka-Koga stage IVb (distant metastases). * Pregnancy. * Serious concomitant systemic disorder incompatible with the study. * Tumour motion \> 0.5 cm on two repeated 4DCT
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What it tests

  • Proton radiation
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Where

3 sites
Department of Oncology, Norrlands Universitetssjukhus
Umeå, Sweden
Department of Oncology, Karolinska University Hospital
Stockholm, Sweden
Department of Oncology, Sahlgrenska University Hospital
Gothenburg, Sweden
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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