Status:
UNKNOWN
Preoperative Image-guided Identification of Response to Neoadjuvant Chemoradiotherapy in Esophageal Cancer
Lead Sponsor:
UMC Utrecht
Collaborating Sponsors:
University Medical Center Groningen
The Netherlands Cancer Institute
Conditions:
Esophageal Cancer
Esophageal Adenocarcinoma
Eligibility:
All Genders
18+ years
Brief Summary
Rationale: For locally advanced esophageal cancer the standard treatment consists of 5 weeks of neoadjuvant chemoradiotherapy (nCRT) followed by surgery. Surgery is currently performed independent of ...
Eligibility Criteria
Inclusion
- Histologically confirmed squamous cell carcinoma or adenocarcinoma of the esophagus or gastroesophageal junction (i.e. tumors involving both cardia and esophagus on endoscopy)
- Potentially resectable locally advanced esophageal tumor (cT1b-4a N0-3 M0): based on standard primary staging by EUS and 18F-FDG PET-CT
- Scheduled to receive neoadjuvant chemoradiotherapy according to CROSS-regimen1: weekly administration of carboplatin and paclitaxel for 5 weeks and concurrent radiotherapy (41.4 Gray in 23 fractions, 5 days per week) followed by esophagectomy
- Age \> 18 years
Exclusion
- Patients who meet exclusion criteria for MRI
- Patients who meet exclusion criteria for intravenous gadolinium-based contrast:
- Glomerular Filtration Rate (GFR) of \<30 mL/min/1.73m2
- Nephrogenic Systemic Fibrosis (strict contra-indication for gadolinium-based contrast)
- Known allergy for gadolinium-based contrast
- Patients with a blood plasma glucose concentration \>10 mmol/L or poorly controlled diabetes mellitus
- Endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) of primary tumor prior to start of neoadjuvant chemoradiotherapy
- Pregnant or breast-feeding patients
Key Trial Info
Start Date :
April 9 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2022
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT03474341
Start Date
April 9 2018
End Date
January 1 2022
Last Update
November 16 2020
Active Locations (4)
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1
Amsterdam University Medical Centers, Academic Medical Center
Amsterdam, Netherlands
2
Antoni van Leeuwenhoek - Netherlands Cancer Institute (NKI-AVL)
Amsterdam, Netherlands
3
University Medical Center Groningen (UMCG)
Groningen, Netherlands
4
University Medical Center Utrecht (UMCU)
Utrecht, Netherlands, 3584 CX