Study on Proton Radiotherapy of Thymic Malignancies — PROTHYM  

Cardiotoxicity Clinical Trial

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

Status Recruiting

Clinical Trial 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

Clinical Trial Description

All doses are recorded in Gy(RBE).

After having checked all eligibility criteria patients will receive:

• 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)

• Patients not willing to participate in study will receive photon therapy according to local practice (≥45 Gy)

Induction or adjuvant chemotherapy may be used according to local practice. Concomitant chemotherapy is not allowed. ;

Related Conditions & MeSH terms

• Cardiotoxicity
• Pulmonary Toxicity
• Thymoma
• Thymus Neoplasms

• NCT number: NCT04822077
• Study type: Interventional
• Source: Swedish Lung Cancer Study Group
• Contact: Jan Nyman, Ass.prof.
• Phone: +46313421000
• Email: jan.nyman@oncology.gu.se
• Status: Recruiting
• Phase: N/A
• Start date: April 18, 2018
• Completion date: April 1, 2029