Study on Proton Radiotherapy of Thymic Malignancies

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

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

Conditions6

Browse More Trials