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Study on Proton Radiotherapy of Thymic Malignancies
Sponsor: Ass. Prof. Jan Nyman
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
Official title: PROTHYM - Phase II Non-randomized Study on Proton Radiotherapy Of Thymic Malignancies
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2018-04-18
Completion Date
2029-04-01
Last Updated
2021-03-30
Healthy Volunteers
No
Interventions
Proton 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)
Locations (3)
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