Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT03984019 |
| Other study ID # |
M19CCR |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 13, 2021 |
| Est. completion date |
April 1, 2023 |
Study information
| Verified date |
May 2023 |
| Source |
The Netherlands Cancer Institute |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The investigators aim to optimize the radiation treatment of early stage lung cancer
patients. Therefore, detailed understanding is needed of the type of toxicity and the
location of these toxicities for patients who receive high fraction doses. These have not
been measured in these patients before, therefore our primary research question is: is it
possible to measure changes in cardiac condition after radiotherapy, with respect to cardiac
arrhythmias, fibrosis, hemodynamic function change and pericarditis?
Description:
Rationale: For lung cancer patients that receive thoracic irradiation, cardiac toxicity was
not considered to play a role, because it was expected to occur many years after treatment.
However, recently several studies have shown higher death rates for lung cancer patients
receiving higher cardiac doses, possibly due to cardiac toxicity. Most knowledge on cardiac
toxicity that is available, is based on patients that receive conventionally fractionated
radiation treatment, where the heart receives a relatively low dose of radiation. For
patients that receive stereotactic body radiation therapy (SBRT), which gives high fraction
doses, the heart may receive peak doses of radiation, especially for centrally located lung
tumours. This type of therapy is standard of care for early stage lung cancer patients, with
very high local control that is similar to surgically treated patients. In order to improve
the radiation treatment for these early stage lung cancer patients, detailed knowledge on
cardiac toxicity in these patients is necessary.
Objective: the investigators aim to optimize the radiation treatment of early stage lung
cancer patients. To reach that goal, detailed understanding is needed of the type of toxicity
and the location on the heart of these toxicities for patients who receive high fraction
doses. These have not been measured in this category of patients before, therefore our
primary research question is: is it possible to measure changes in cardiac condition 3 or 12
months after radiotherapy, with respect to cardiac arrhythmias, tissue fibrosis, hemodynamic
function change and pericarditis? Our secondary research question is: is it possible to
measure local fibrosis and correlate this to local dose? The third research question is: is
it possible to measure early cardiac morphology changes during the course of the irradiation?
Study design: Twenty five patients with early stage lung cancer or a solitary lung metastasis
of a solid tumour, who are treated with SBRT will be enrolled in an observational prospective
cohort study and treated following standard clinical practice on a cone-beam or MR guided
linear accelerator (Linac). Condition of the heart will be examined before treatment using
ECG, cardiac MRI with added T1- and T2-mapping, echocardiography and blood biomarkers. These
tests will be repeated 3 and 12 months after treatment.
Study population: 25 patients with a lung tumour in close proximity to the heart (edge of
tumour <3cm from the heart) will be included. All patients receive SBRT for a primary lung
tumour (stage IA-IIB), or for a solitary lung metastasis of a solid tumour.
Intervention (if applicable): not applicable Main study parameters/endpoints: It will be
investigated 1) if changes in cardiac condition (cardiac arrhythmias, fibrosis, hemodynamic
function change and pericarditis) can be visualised and quantified. A negative change of more
than 5% between pre-and post-treatment measurements is considered toxicity. 2) If local
fibrosis is associated to local dose, 3) if morphology changes are visible during treatment.
Nature and extent of the burden and risks associated with participation, benefit and group
relatedness: The patient will have 3 sessions with several diagnostic tests: ECGs, cardiac
MRIs, echocardiography and blood sampling, and will fill out 3 questionnaires. Limited side
effects of these tests are expected. Cardiac tests will be evaluated by a cardiologist and
dedicated radiologist and reported to the radiation oncologist who will inform the patient
and refer to the cardiologist if needed. The burden for these patients will be, next to the
time spent for the diagnostic tests and travel time; an intravenous blood sampling and
administration of MRI contrast agent. The additional time spent for diagnostic tests per
session are: echo (30 min), ECG (5 min), vena puncture (5 min) and MRI (45 min) + time in the
waiting room. Filling out the 3 questionnaires will take 15 min each. The possible benefit
for the patient is the extensive cardiac screening. Should a problem come to light, the
patient will be referred to the cardiologist.
Results from this patient cohort are directly relatable to all early stage NSCLC who are
treated with SBRT, and possibly oesophageal cancer patients as well. Should this study show
that cardiac dose causes cardiac toxicity in this time frame, the aim should be to improve
treatment for all patients who are comparable. Ergo, patients who receive cardiac dose
because of their tumour location, and who are generally unfit for surgery because of their
physical condition (early stage NSCLC patients and oesophageal cancer patients).
