Cardiotoxicity Clinical Trial
Official title:
PROTHYM - Phase II Non-randomized Study on Proton Radiotherapy Of Thymic Malignancies
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
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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05271162 -
Empagliflozin in the Prevention of Cardiotoxicity in Cancer Patients Undergoing Chemotherapy Based on Anthracyclines
|
Phase 3 | |
| Recruiting |
NCT04262830 -
Cancer Therapy Effects on the Heart
|
||
| Completed |
NCT02909712 -
Cardiac Safety of Dihydroartemisinin-Piperaquine Amongst Pregnant Women in Tanzania
|
Phase 2 | |
| Recruiting |
NCT04092309 -
Effect of Angiotensin Converting Enzyme and Sacubitril Valsartan in Patients After Bone Marrow Transplantation
|
N/A | |
| Recruiting |
NCT04790266 -
Early Detection of Cardiotoxicity From Systemic and Radiation Therapy in Breast Cancer Patients
|
||
| Enrolling by invitation |
NCT04305613 -
Cardiotoxicity in Locally Advanced Lung Cancer Patients Treated With Chemoradiation Therapy
|
||
| Not yet recruiting |
NCT05040867 -
Exercise Prescription Guided by Heart Rate Variability in Breast Cancer Patients
|
N/A | |
| Recruiting |
NCT05851053 -
Breast Cancer Long-term Outcomes on Cardiac Functioning: a Longitudinal Study
|
||
| Recruiting |
NCT05992337 -
New Biomarkers in the Prediction of Chemotherapy-induced Cardiotoxicity.
|
||
| Enrolling by invitation |
NCT04877899 -
Mazankowski Alberta Heart Institute (MAHI) EchoGo Discovery 1 Protocol
|
||
| Recruiting |
NCT05096338 -
Mechanisms, Predictors, and Social Determinants of Cardiotoxicity in Prostate Cancer
|
||
| Recruiting |
NCT05078190 -
Mechanisms, Predictors, and Social Determinants of Cardiotoxicity in Breast Cancer
|
||
| Recruiting |
NCT04632407 -
Can Flaxseed Prevent Broken Hearts in Women With Breast Cancer Study?
|
N/A | |
| Completed |
NCT00543062 -
Staccato Prochlorperazine Thorough QT/QTc
|
Phase 1 | |
| Recruiting |
NCT05159479 -
Defining Robust Predictors of Chemotherapy Related Cardiotoxicity
|
||
| Not yet recruiting |
NCT06005259 -
Effect of Spironolactone in the Prevention of Anthracycline-induced Cardiotoxicity (SPIROTOX)
|
Phase 4 | |
| Recruiting |
NCT05406635 -
Imaging Versus Cardiac Biomarker Monitored HER2 Directed Therapy in Patients With Breast Cancer
|
N/A | |
| Recruiting |
NCT04047901 -
Effect of Physical Training in Patients With Heart Failure Caused by Chemotherapy for Cancer Treatment
|
N/A | |
| Terminated |
NCT03038997 -
Early Detection of Cardiac Toxicity in Childhood Cancer Survivors
|
||
| Completed |
NCT01246778 -
Sunitinib and Atrial Trabeculae Contractility
|
N/A |