PROTHYM - Phase II Non-randomized Study on Proton Radiotherapy Of Thymic Malignancies
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cardiotoxicity
- Sponsor
- Ass. Prof. Jan Nyman
- Enrollment
- 40
- Locations
- 3
- Primary Endpoint
- Cardiotoxicity and pulmonary toxicity of therapy
- Status
- Recruiting
- Last Updated
- 5 years ago
Overview
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.
Investigators
Ass. Prof. Jan Nyman
Head of Swedish Lung Cancer Study Group, Ass. Prof.
Swedish Lung Cancer Study Group
Eligibility Criteria
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 -
- •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
Outcomes
Primary Outcomes
Cardiotoxicity and pulmonary toxicity of therapy
Time Frame: At 60 months from treatment
Proportion of patients with cardiac and pulmonary toxicity measured by CTCAE 4.0 \> Grade 2
Local tumor control
Time Frame: At 60 months from treatment
Freedom from tumor progression (CR,PR or SD) mesured by CT-scan
Secondary Outcomes
- Quality of life questionnaire EORTC QLQ 30 (European Organisation for Research and Treatment of Cancer)(At 60 months from treatment)
- Quality of life questionnaire LC13 (Lung cancer specific module of EORTC)(At 60 months from treatment)
- Survival(From treatment and for 5 years)