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Clinical response evaluation after neoadjuvant chemoradiotherapy in esophageal cancer

Accuracy of detecting residual disease after chemoradiotherapy preceding surgery for oesophageal cancer

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON21053
Enrollment
120
Registered
2014-10-06
Start date
2013-07-22
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

English: Squamous cell- or adenocarcinoma of the oesophagus or oesophago-gastric junction. Dutch: Plaveiselcel- of adenocarcinoom van de slokdarm of gastro-oesophageale overgang.

Interventions

Approximately 4-6 weeks after completion of nCRT all included patients will undergo a first clinical response evaluation (CRE-I) including endoscopy with (random) conventional mucosal biopsies of the

Sponsors

Erasmus MC – University Medical Center Rotterdam Academic Medical Center Amsterdam University Medical Center Utrecht Catharina Cancer Center Eindhoven Atrium Medical Center Heerlen
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients who are planned to undergo neoadjuvant chemoradiotherapy according to CROSS, followed by surgical resection for histologically proven oesophageal squamous cell carcinoma or adenocarcinoma are eligible for this study. Written, voluntary informed consent

Exclusion criteria

Exclusion criteria: Dementia or altered mental status prohibiting the understanding and giving of informed consent

Design outcomes

Primary

MeasureTime frame
The main study parameter is the correlation between the clinical response during CRE-I and CRE-II (CRE= clinical response evaluation) and the final pathological response in the resection specimen (as measured by the modified tumour regression grading system of Chirieac).

Secondary

MeasureTime frame
R0-resection rates for all included patients that undergo resection.

Contacts

Public ContactB.J. Noordman

Department of Surgery, Room Z-839, Erasmus MC – University Medical Center Rotterdam P.O. Box 2040

b.noordman@erasmusmc.nl0031 10 703 88 13

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)