Study on Proton Radiotherapy of Thymic Malignancies
Recruiting now · Not applicable
Conditions studied: Cardiotoxicity, Pulmonary Toxicity, Thymus Neoplasms
In brief
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
Key facts
- Study ID
- NCT04822077
- Run by
- Ass. Prof. Jan Nyman
- People needed
- 40
- Starts
- 2018-04-18
- Expected to finish
- 2029-04-01
- Last updated by the study team
- 2021-03-30
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 is running
- Department of Oncology, Norrlands Universitetssjukhus — Umeå, Norrland, Sweden (enrolling)
- Department of Oncology, Sahlgrenska University Hospital — Gothenburg, Västra Götaland County, Sweden (enrolling)
- Department of Oncology, Karolinska University Hospital — Stockholm, Stockholm County, Sweden
Full record on ClinicalTrials.gov
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