Proton radiotherapy for thymic tumors
Official title: PROTHYM - Phase II Non-randomized Study on Proton Radiotherapy Of Thymic Malignancies
Run by Swedish Lung Cancer Study Group · NCT04822077 · Data updated 2026-11-12
This study is testing whether proton beam radiotherapy can help people with thymic tumors feel better and live longer after surgery or if their tumors can’t be removed.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Swedish Lung Cancer Study Group Research network |
| Drugs / interventions | chemotherapy |
| Locations | 3 sites (Umeå, Norrland and 2 other locations) |
| Status | Recruiting |
| Started | April 18, 2018 |
| Main results expected | April 1, 2026 |
| Study ends | April 1, 2029 |
| Registry record updated | March 30, 2021 |
| Trial ID | NCT04822077 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults over 18 with a diagnosis of thymoma or thymic carcinoma, particularly those with specific stages and histological types.
✕Probably not a fit
Patients with distant metastases, serious systemic disorders, or significant tumor motion may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multicenter, non-randomized phase II study evaluates the effectiveness of proton beam radiotherapy in patients with thymic epithelial tumors, including thymoma and thymic carcinoma, either post-surgery or inoperable with localized disease. The study aims to assess primary endpoints such as cardiac and pulmonary toxicity, as well as local control over five years. Secondary endpoints include progression-free survival, overall survival, quality of life, and relapse patterns. Patients who are not suitable for proton treatment will be monitored after receiving standard photon therapy.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment outcomes and reduced toxicity for patients with thymic malignancies.
How similar studies have gone: Other studies have shown promise with proton therapy for various cancers, suggesting potential success for this approach in thymic malignancies.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Department of Oncology, Norrlands Universitetssjukhus
Umeå, Norrland, Sweden Recruiting -
Department of Oncology, Sahlgrenska University Hospital
Gothenburg, Västra Götaland County, Sweden Recruiting -
Department of Oncology, Karolinska University Hospital
Stockholm, Stockholm County, Sweden Not yet recruiting
Study contacts
- Study coordinator: Jan Nyman, Ass.prof.
- Email: jan.nyman@oncology.gu.se
- Phone: +46313421000
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.