Study on Proton Radiotherapy of Thymic Malignancies
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAss. Prof. Jan Nyman
About this trial
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
Eligibility criteria
Qualifiers
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)
Disqualifiers
Masaoka-Koga stage IVb (distant metastases).
Pregnancy.
Serious concomitant systemic disorder incompatible with the study.
Tumour motion > 0.5 cm on two repeated 4DCT
Trial design
Treatments tested in this trial
- Proton radiation
Treatment groups
40 Participants
are divided into 1 treatment groupSponsors and collaborators
Ass. Prof. Jan Nyman
Lead sponsor
Swedish Lung Cancer Study Group
Sponsor institution
Source ClinicalTrials.gov