Cardiotoxicity, Pulmonary Toxicity, Thymus Neoplasms
Conditions
Keywords
Thymoma, Thymic carcinoma, Proton radiotherapy
Brief summary
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
Detailed description
All doses are recorded in Gy(RBE). After having checked all eligibility criteria patients will receive: * 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) * Patients not willing to participate in study will receive photon therapy according to local practice (≥45 Gy) Induction or adjuvant chemotherapy may be used according to local practice. Concomitant chemotherapy is not allowed.
Interventions
* 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)
Sponsors
Study design
Intervention model description
Phase II study
Eligibility
Inclusion criteria
* 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.
Exclusion criteria
* Masaoka-Koga stage IVb (distant metastases). * Pregnancy. * Serious concomitant systemic disorder incompatible with the study. * Tumour motion \> 0.5 cm on two repeated 4DCT
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiotoxicity and pulmonary toxicity of therapy | At 60 months from treatment | Proportion of patients with cardiac and pulmonary toxicity measured by CTCAE 4.0 \> Grade 2 |
| Local tumor control | At 60 months from treatment | Freedom from tumor progression (CR,PR or SD) mesured by CT-scan |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life questionnaire EORTC QLQ 30 (European Organisation for Research and Treatment of Cancer) | At 60 months from treatment | Scale from 1-100 for 30 items, higher score indicates a better situation. |
| Quality of life questionnaire LC13 (Lung cancer specific module of EORTC) | At 60 months from treatment | Scale from 1-100 for 13 items and higher score indicates worse symptoms. |
| Survival | From treatment and for 5 years | Overall survival |
Countries
Sweden