NCT03396614: CROSS SECT

Detection of (Sub)Clinical Toxicity in Irradiated vs. Non-irradiated Surgically Treated Esophageal Cancer Patients: a Pilot Study (CROSS SECT)

Completed Last updated 28 February 2024

What this trial tests

trial testing CTTC scan, cardiac MRI, ECG, 6 minute walking test, echocardiogram in Thoracic Tumor in 40 participants. Completed in 1 November 2020.

Timeline

21 October 2017

Primary endpoint
1 October 2020

1 November 2020

Quick facts

Lead sponsor	University Medical Center Groningen
Status	Completed
Study type	OBSERVATIONAL
Enrollment	40
Start date	21 October 2017
Primary completion	1 October 2020
Estimated completion	1 November 2020
Sites	1 location across Netherlands

Drugs / interventions tested

• CTTC scan, cardiac MRI, ECG, 6 minute walking test, echocardiogram

Conditions studied

• Thoracic Tumor — all drugs for Thoracic Tumor →

Sponsor

University Medical Center Groningen

Who can join

Adults 18 to 100, any sex, with Thoracic Tumor. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Rationale: Radiation-induced cardiac and pulmonary toxicity after treatment for intra-thoracic tumors is a clinically relevant problem, which may jeopardize the benefit of (neo-adjuvant) (chemo) radiotherapy. Although cure rates are rising since the introduction of neo-adjuvant chemoradiation (neo-CRT) as current standard treatment for esophageal cancer (EC), recent studies showed that there is a substantial risk of non-cancer treatment-related death in these patients. Furthermore, this risk is underestimated as the cause of death of many patients remains unknown, since the distinction between tumor related and non-cancer related death can be difficult.

Cardiac and pulmonary toxicity and its interaction as seen in pre-clinical studies might explain for these unknown deaths as suggested in several clinical studies. Clinical imaging studies performed shortly after treatment showed changes in different cardiac function parameters, all related to radiation dose parameters. Systematic imaging studies analysing subclinical toxicities at longer follow up have never been performed, most probably because of poor survival rates. However, identification of the magnitude of (subclinical) cardiopulmonary toxicity, by performing several cardiopulmonary function tests, is essential in this patient group as this toxicity is most likely the cause of the increased mortality after thoracic radiotherapy. For future perspectives, these results can be used to select the best diagnostic methods for a prospective cohort study to develop prediction tools for cardiopulmonary toxicity..

Objective: The main objective of this study is to determine the most suitable diagnostic test to identify cardiopulmonary (dys)function in EC survivors treated with neo-CRT followed by surgical resection. Furthermore, we want to estimate the difference in cardiopulmonary (dys)function in EC survivors treated with neo-CRT followed by surgical resection compared to EC survivors who were treated with surgical resection alone.

Study design: Cross-sectional pilot study

Study population: 40 EC patients who were treated with curative intent by esophageal resection with or without neo-CRT

Intervention (if applicable): Not applicable.

Main study parameters/endpoints: As this is an exploratory pilot study to determine the most suitable diagnostic tests for future studies, there will be several endpoints related to (sub)clinical cardiopulmonary dysfunction.

Signs of myocardial ischemia, systolic or diastolic dysfunction, rhythm and valve disorders, pericardial effusion and fibrosis, myocardial fibrosis, focal wall motion disorders and coronary calcifications will be analyzed. The cardiopulmonary (dys)function in EC survivors treated with neo-CRT followed by surgical resection will be compared to cardiopulmonary (dys)function in EC survivors treated with surgical resection alone.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Several tests will be performed at one time point, 5-10 years after given treatment. If the findings of the test indicate cardiovascular complications, the patient will be referred to the cardiologist for further analysis and/or preventive measures. As one of the tests, cardiac MRI, including gadolinium (Dotarem 0.2 mmol/kg) enhancement will be performed. Potential side effects of gadolinium include brief headache, nausea (feeling sick) and dizziness for a brief time following the injection. Allergic reactions are rare. Furthermore, a cardiac CT scan will be performed with a total radiation exposure of 0.6 mSv (less than a third of the annual background radiation dose), the risks will be minimal.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.