Actively Recruiting
Study on Proton Radiotherapy of Thymic Malignancies
Led by Ass. Prof. Jan Nyman · Updated on 2021-03-30
40
Participants Needed
3
Research Sites
571 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Study on Proton Radiotherapy of Thymic Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- With non-radical surgery (R1 or R2) or inoperable patient or patient refusing surgery: stage I to IVa, any histology
- Performance status WHO 0 to 2
- Lung function with FEV1 greater than 1 liter or more than 40% of predicted and CO diffusion capacity greater than 40% of predicted (postoperative measures)
- Age 18 years or older, no upper age limit
- Written informed consent from patients
You will not qualify if you...
- Masaoka-Koga stage IVb (distant metastases)
- Pregnancy
- Serious concomitant systemic disorder incompatible with the study
- Tumour motion greater than 0.5 cm on two repeated 4DCT scans
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Department of Oncology, Norrlands Universitetssjukhus
Umeå, Norrland, Sweden, 901 85
Actively Recruiting
2
Department of Oncology, Karolinska University Hospital
Stockholm, Stockholm County, Sweden, 171 76
Not Yet Recruiting
3
Department of Oncology, Sahlgrenska University Hospital
Gothenburg, Västra Götaland County, Sweden, 413 45
Actively Recruiting
Research Team
J
Jan Nyman, Ass.prof.
CONTACT
A
Andreas Hallqvist, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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