Clinical trial Recruiting at 2 sites Interventional Ages 18 and up

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 typeInterventional
Ages18 Years and up
SexAll
Enrollment40 (estimated)
SponsorSwedish Lung Cancer Study Group
Research network
Drugs / interventionschemotherapy
Locations3 sites (Umeå, Norrland and 2 other locations)
StatusRecruiting
StartedApril 18, 2018
Main results expectedApril 1, 2026
Study endsApril 1, 2029
Registry record updatedMarch 30, 2021
Trial IDNCT04822077 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.