Health Trials

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 group

Locations

3
Department of Oncology, Norrlands Universitetssjukhus901 85, UmeåNorrland, Sweden
Department of Oncology, Karolinska University Hospital171 76, StockholmStockholm County, Sweden
Department of Oncology, Sahlgrenska University Hospital413 45, GothenburgVästra Götaland County, Sweden

Sponsors and collaborators

Ass. Prof. Jan Nyman

Lead sponsor

Swedish Lung Cancer Study Group

Sponsor institution

Source ClinicalTrials.gov