National clinical study

Circulating tumor DNA (ctDNA) as predictor of pathological complete response and survival after chemoradiotherapy in esophageal squamous cell carcinoma (ESCC) - A path to an organ preserving strategy

Patients with resectable esophageal squamous cell carcinoma (ESCC) are currently managed with neoadjuvant chemoradiotherapy followed by esophagectomy. However, surgery is challenging, resulting in impaired quality of life due to permanent changes in eating habits. Therefore, an organ preserving approach has been proposed with the omission of surgery in selected patients.

The project received funding in 2024.

Principal Investigator (PI)

 

Morten Mau-Sørensen
Morten Mau-SørensenChief Physician, Professor
Department of Oncology, Copenhagen University Hospital (Rigshospitalet)

Collaborators

 

North Denmark Region

Central Denmark Region

Region Zealand

Capital Region of Denmark

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Patient enrollment

39

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Cancer

Esophageal cancer


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Type

Prospective observational

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Platform

ddPCR

Abstract

 

Patients with resectable esophageal squamous cell carcinoma (ESCC) are currently managed with neoadjuvant chemoradiotherapy followed by esophagectomy. However, surgery is challenging, resulting in impaired quality of life due to permanent changes in eating habits. Therefore, an organ preserving approach has been proposed with the omission of surgery in selected patients. This project aims to evaluate whether ctDNA after chemoradiotherapy can serve as a tool to determine if patients should be managed with salvage surgery or organ preservation. Plasma and tissue samples in 39 patients treated with neoadjuvant chemoradiotherapy will be used. ctDNA will be detected by a tumor-informed approach using digital droplet PCR designed based on DNA sequencing of the primary tumor. Omission of surgery is considered indicated in patients with no residual disease following chemoradiotherapy. Correlative analyses will be performed to determine if non-detectable ctDNA is predictive of overall survival and pathological complete response defi ned as absence of viable tumor cells in the surgical specimens. In conclusion, this study has the potential to identify resectable patients with ESCC who can benefi t from organ preserving treatment sparing patients from the harmful eff ects of major surgery.

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ADDRESS FOR THE SECRETARIAT

Science Center Skejby, MOMA
Brendstrupgårdsvej 21, build. A
8200 Aarhus N