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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Proton radiation
Radiation* Patients with radical surgery and unfavourable histology (B2, B3, C) and/or Masaoka-Koga stage III, IVa: 2 Gy(RBE), once daily, five days a week to a total dose of 50 Gy(RBE). * Patients with non-radical surgery (R1 resection) regardless of stage and histology: 2.3 Gy(RBE), once daily, 5 days a week to a total dose of 57.5 Gy(RBE) * Inoperable patients regardless of stage and histology and patients with R2 non-radical resection: 2.5 Gy (RBE), once daily, 5 days a week to a total dose of 62.5 Gy(RBE)
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Proton radiotherapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Cardiotoxicity and pulmonary toxicity of therapy
Proportion of patients with cardiac and pulmonary toxicity measured by CTCAE 4.0 \> Grade 2
Time frame
At 60 months from treatment2
Local tumor control
Freedom from tumor progression (CR,PR or SD) mesured by CT-scan
Time frame
At 60 months from treatmentSecondary outcomes
1
Quality of life questionnaire EORTC QLQ 30 (European Organisation for Research and Treatment of Cancer)
Scale from 1-100 for 30 items, higher score indicates a better situation.
Time frame
At 60 months from treatment2
Quality of life questionnaire LC13 (Lung cancer specific module of EORTC)
Scale from 1-100 for 13 items and higher score indicates worse symptoms.
Time frame
At 60 months from treatment3
Survival
Overall survival
Time frame
From treatment and for 5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Ass. Prof. Jan Nyman
Lead sponsor
Swedish Lung Cancer Study Group
Sponsor institution
Source ClinicalTrials.gov