Status:
RECRUITING
Study on Proton Radiotherapy of Thymic Malignancies
Lead Sponsor:
Ass. Prof. Jan Nyman
Conditions:
Cardiotoxicity
Pulmonary Toxicity
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 inope...
Detailed 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 sta...
Eligibility Criteria
Inclusion
- 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
- Masaoka-Koga stage IVb (distant metastases).
- Pregnancy.
- Serious concomitant systemic disorder incompatible with the study.
- Tumour motion \> 0.5 cm on two repeated 4DCT
Key Trial Info
Start Date :
April 18 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2029
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04822077
Start Date
April 18 2018
End Date
April 1 2029
Last Update
March 30 2021
Active Locations (3)
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1
Department of Oncology, Norrlands Universitetssjukhus
Umeå, Norrland, Sweden, 901 85
2
Department of Oncology, Karolinska University Hospital
Stockholm, Stockholm County, Sweden, 171 76
3
Department of Oncology, Sahlgrenska University Hospital
Gothenburg, Västra Götaland County, Sweden, 413 45