RecruitingNot ApplicableNCT04822077

Study on Proton Radiotherapy of Thymic Malignancies

PROTHYM - Phase II Non-randomized Study on Proton Radiotherapy Of Thymic Malignancies

Sponsor

Ass. Prof. Jan Nyman

Enrollment

40 participants

Start Date

Apr 18, 2018

Study Type

INTERVENTIONAL

Conditions

Cardiotoxicity Thymus Neoplasms Pulmonary Toxicity

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

Min Age: 18 Years

Inclusion Criteria6

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 Criteria4

Masaoka-Koga stage IVb (distant metastases).
Pregnancy.
Serious concomitant systemic disorder incompatible with the study.
Tumour motion \> 0.5 cm on two repeated 4DCT

Interventions

RADIATIONProton radiation

* Patients with radical surgery and unfavourable histology (B2, B3, C) and/or Masaoka-Koga stage III, IVa: 2 Gy(RBE), once daily, five days a week to a total dose of 50 Gy(RBE). * Patients with non-radical surgery (R1 resection) regardless of stage and histology: 2.3 Gy(RBE), once daily, 5 days a week to a total dose of 57.5 Gy(RBE) * Inoperable patients regardless of stage and histology and patients with R2 non-radical resection: 2.5 Gy (RBE), once daily, 5 days a week to a total dose of 62.5 Gy(RBE)