Study on Proton Radiotherapy of Thymic Malignancies
Recruiting · NCT04822077 · Interventional (participants receive a specific treatment) · Lead sponsor: Ass. Prof. Jan Nyman
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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
Who can take part
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 is running
3 locations listed.
- Department of Oncology, Norrlands Universitetssjukhus - Umeå, Norrland, Sweden
- Department of Oncology, Karolinska University Hospital - Stockholm, Stockholm County, Sweden
- Department of Oncology, Sahlgrenska University Hospital - Gothenburg, Västra Götaland County, Sweden