Preoperative identification of response to neoadjuvant chemoradiotherapy for esophageal cancer

Completed

• Conditions: esophageal cancer; oesophageal carcinoma; 10017990; 10017991

• Registration Number: NL-OMON39900
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

- Histologically confirmed carcinoma of the esophagus or esophagogastric junction (i.e. tumors involving both cardia and esophagus on endoscopy)
- Potentially resectable tumor (cT1b-4a N0-3 M0)
- Undergoing neoadjuvant chemoradiation according to CROSS-regimen
- Age >18 years
- No history of other cancer or previous radiotherapy or chemotherapy
- Signed informed consent

Exclusion Criteria

- Patients who meet exclusion criteria for MRI at 1.5T following the protocol of the Radiology department of the UMC Utrecht
- Glomerular Filtration Rate (GFR) of <45 mL/min/1.73m2, unless the patient has risk factors for contrast nefropathy according to the UMC Utrecht protocol *Preventie contrastreactie en contrast nefropathie, Versie 2 februari 2012*. In patients with risk factors a minimum GFR of 60 mL/min/1.73m2 will be required
- Patients with insulin dependent diabetes mellitus or a blood plasma glucose concentration higher than 10 mmol/L
- Patients with a known Gadovist allergy
- Patients with a known CT-contrast allergy
- Patients having difficulty understanding Dutch
- Pregnant or breast-feeding patients

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Exploration of the diagnostic value of anatomical and functional MRI and<br /><br>PET-CT in the evaluation of treatment response to nCRT for patients with<br /><br>esophageal cancer, as compared to the pathological specimen as gold standard.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Assessment of the optimal (MRI and PET-CT) imaging parameters that correlate<br /><br>best with pathological response.<br /><br>- Assessment of the optimal timing for the imaging series.<br /><br>- Assessment of the diagnostic value of MRI for post-nCRT restaging of T- and<br /><br>N-stage as compared to histopathology.<br /><br>- Assessment of the experienced burden for the patient associated with extra<br /><br>MRI and PET-CT scanning in the clinical work-up for esophageal cancer.</p><br>