NCT04822077 Study on Proton Radiotherapy of Thymic Malignancies
| NCT ID | NCT04822077 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ass. Prof. Jan Nyman |
| Condition | Cardiotoxicity |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2018-04-18 |
| Primary Completion | 2026-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2018-04-18 with a primary completion date of 2026-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Hillevi Rylander, MD
STUDY DIRECTOR
Head of Skandion Clinic
Frequently Asked Questions
Who can join the NCT04822077 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cardiotoxicity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04822077 currently recruiting?
Yes, NCT04822077 is actively recruiting participants. Contact the research team at jan.nyman@oncology.gu.se for enrollment information.
Where is the NCT04822077 trial being conducted?
This trial is being conducted at Umeå, Sweden, Stockholm, Sweden, Gothenburg, Sweden.
Who is sponsoring the NCT04822077 clinical trial?
NCT04822077 is sponsored by Ass. Prof. Jan Nyman. The principal investigator is Hillevi Rylander, MD at Head of Skandion Clinic. The trial plans to enroll 40 participants.