NCT04822077Recruiting
Study on Proton Radiotherapy of Thymic Malignancies
PROTHYM - Phase II Non-randomized Study on Proton Radiotherapy Of Thymic Malignancies
Source: ClinicalTrials.gov · Last updated 30 Mar 2021 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 11 Mar 2021
- Start date
- 18 Apr 2018
- Primary completion date
- 1 Apr 2026
- Lead sponsor
- Ass. Prof. Jan Nyman
- NCT number
- NCT04822077
What you commit to
- Study type: Interventional
- Planned participants: 40
- From 18 Apr 2018 to the primary completion date, 1 Apr 2026
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Serious concomitant systemic disorder incompatible with the study.
Other
- Masaoka-Koga stage IVb (distant metastases).
- Pregnancy.
- Tumour motion \> 0.5 cm on two repeated 4DCT
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Oncology, Sahlgrenska University Hospital Coordinator of this site? Confirm its status | Gothenburg | Sweden | Recruiting |
| Department of Oncology, Karolinska University Hospital Coordinator of this site? Confirm its status | Stockholm | Sweden | Not yet recruiting |
| Department of Oncology, Norrlands Universitetssjukhus Coordinator of this site? Confirm its status | Umeå | Sweden | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.