The main objective of this study is to find a correlation between the rise in NT pro BNP level and the radiation dose given to the heart.
ID
Source
Brief title
Condition
- Myocardial disorders
- Malignant and unspecified neoplasms gastrointestinal NEC
- Respiratory tract neoplasms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Percentage of rise of the level of NT pro BNP after radiotherapy
Secondary outcome
• A new diagnosis of: heart failure, myocardial infarction or a newly diagnosed
rhythm disorder will be scored as a cardiac event. Myocardial ischaemia
requiring intervention and changes in cardiac medication in case of
deterioration of known heart failure will be analysed by a cardiologist to
decide whether or not to score this as an event. Events will be scored
according the CTCAE 4.2 criteria.
• Percentage of rise of hs-TNT during or after treatment
Background summary
Radiation induced cardiac toxicity after treatment for intrathoracic tumours is
a clinically relevant problem. So far, no clinical prediction models exist for
cardiac toxicity. In particular, the relationship between radiation dose
parameters and the risk of cardiac toxicity remains to be determined.
Clinical prediction models for cardiac toxicity are difficult to obtain, e.g.
due to long latency time. Therefore, objective surrogate markers, for cardiac
toxicity such as NT pro BNP and hs-TNT, as obtained during and after treatment
may be of great value.
Study objective
The main objective of this study is to find a correlation between the rise in
NT pro BNP level and the radiation dose given to the heart.
Study design
prospective evaluation of blood parameters
Study burden and risks
Participation in this study does not involve any additional risk to patients.
For most patients blood sample collection during treatment can be done
simultaneously during blood sample collection for regular check.
Extra punctures are required three to four times during follow up visits as
routine blood sample collection for these patient groups is usually not
performed.
Blood withdrawal may result in local tenderness or hematoma, which are
self-limiting.
Risk models predicting cardiac damage after radiotherapy will improve decision
making for radiation treatment planning and techniques. Surrogate early
endpoints will improve the model and select patients who are at higher risk for
developing cardiac events. Those patients are probably candidates for early
cardiac evaluation as preventive measures can be taken.
Hanzeplein 1
groningen 9713 GZ
NL
Hanzeplein 1
groningen 9713 GZ
NL
Listed location countries
Age
Inclusion criteria
patients with esophageal or non small cell lung cancer with an curative indication for radiotherapy, with or without chemotherapy, with or without surgery.
Exclusion criteria
prior radiotherapy to the chest, treatment with palliative intent
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL50262.042.14 |