An interventional study of Proton radiation in Cardiotoxicity, Pulmonary Toxicity and Thymus Neoplasms, sponsored by Ass. Prof. Jan Nyman. Recruiting at 3 sites in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-03-30.
Sponsored by Ass. Prof. Jan Nyman · Not applicable, Interventional, and Treatment
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:
Induction or adjuvant chemotherapy may be used according to local practice. Concomitant chemotherapy is not allowed.
262 studies on the registry are indexed under Cardiotoxicity; 75 are open to participants now.
This study's planned enrollment of 40 is below the median of 93 across 137 interventional studies indexed under Cardiotoxicity.
Browse Cardiotoxicity studies →Ass. Prof. Jan Nyman is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Proton radiotherapy with RBE doses: * 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)
Radiation: Proton 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)
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 treatment
Local tumor control
Freedom from tumor progression (CR,PR or SD) mesured by CT-scan
Time frame: At 60 months from treatment
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 treatment
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 treatment
Survival
Overall survival
Time frame: From treatment and for 5 years
Plan to share: No — The aim is that the study will be published in international journals. A separate publication will include result of the cardiological data The Vancouver declaration (Br Med J:296, 401-405, 1988) should be followed in all publications based on this study.
Started Apr 2018 (actual). Primary completion is estimated for Apr 2026, 95 months after the start.
Of 48 non-industry interventional studies with no phase under Cardiotoxicity, half reached primary completion within 52 months of starting (the median), counting those still running; a quarter within 35 and three quarters within 73. This study's planned 95 months is above that.
Counting every sponsor, half of 48 studies reached it within 52 months; a quarter within 35 and three quarters within 73.
How these figures are worked out, and which studies are left out of them.
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Ass. Prof. Jan Nyman