Proton radiotherapy for thymic tumors
PROTHYM - Phase II Non-randomized Study on Proton Radiotherapy Of Thymic Malignancies
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Swedish Lung Cancer Study Group Research network |
| Drugs / interventions | chemotherapy |
| Locations | 3 sites (Umeå, Norrland and 2 other locations) |
| Trial ID | NCT04822077 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with a diagnosis of thymoma or thymic carcinoma, particularly those with specific stages and histological types.
Not a fit: Patients with distant metastases, serious systemic disorders, or significant tumor motion may not benefit from this study.
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 performed: Other studies have shown promise with proton therapy for various cancers, suggesting potential success for this approach in thymic malignancies.
Eligibility criteria
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 this trial is running
Umeå, Norrland and 2 other locations
- Department of Oncology, Norrlands Universitetssjukhus — Umeå, Norrland, Sweden (Recruiting)
- Department of Oncology, Karolinska University Hospital — Stockholm, Stockholm County, Sweden (Not_yet_recruiting)
- Department of Oncology, Sahlgrenska University Hospital — Gothenburg, Västra Götaland County, Sweden (Recruiting)
Study contacts
- Study coordinator: Jan Nyman, Ass.prof.
- Email: jan.nyman@oncology.gu.se
- Phone: +46313421000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.