A Biomarker-driven Therapeutic Strategy for Esophageal Cancer Chemoradiotherapy in Patients With Resectable Adenocarcinoma of the ESophagus and Esophagogastric Junction

Esophageal Cancer Clinical Trial

— BoRgES  

Official title:

A Biomarker-driven Therapeutic Strategy for Esophageal Cancer, the BoRgES Trial: a Multicenter Randomized Phase II Study of BIRC3-expression Directed Preoperative Chemoradiotherapy in Patients With Resectable Adenocarcinoma of the ESophagus and Esophagogastric Junction

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04269083
• Other study ID #: GR-2016-02361134
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 24, 2020
• Est. completion date: August 24, 2024

Study information

• Verified date: February 2020
• Source: Azienda Ospedaliera Universitaria Integrata Verona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Preoperative chemoradiotherapy followed by surgery has been accepted as the standard of care for resectable adenocarcinoma of the esophagus and esophagogastric junction (EGJ). However, in a large part of the cases the tumor is extremely resistant to chemoradiotherapy, and those patients do not benefit from this treatment but are exposed to its negative consequences such as toxicity and delayed surgical therapy. The hypothesis is that a biomarker-driven therapeutic strategy in which patients will receive preoperative chemoradiotherapy or upfront surgery based on the basal tumor expression of BIRC3 could improve the R0 resection rate if compared with a standard strategy in unselected patients.

Description:

BoRgES trial is a multicenter, randomized phase II study of BIRC3-expression directed preoperative chemoradiotherapy in patients with resectable adenocarcinoma of the esophagus and EGJ. The main objective of this proposal is to provide evidence for a novel therapeutic strategy with enormous significance for patients affected by this disease.

Only a part of the patients with esophageal adenocarcinoma benefit from neoadjuvant therapy, and the clinical efficacy of chemoradiotherapy is reduced by the pre-existence of cellular drug resistance. Thus, there is an urgent need to identify patients who could not benefit from preoperative treatment. The study will define an innovative therapeutic strategy directed by the expression of BIRC3 as a predictive marker for discriminating patients who will most likely be resistant to preoperative chemoradiotherapy.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 128
• Est. completion date: August 24, 2024
• Est. primary completion date: March 24, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically proven adenocarcinoma of the esophagus and EGJ (Siewert I/II) surgical resectable (cT2-4a, N0-1, M0), as determined by Endoscopic Ultra Sound (EUS) and or PET-TC scan. cT1N1 tumors are eligible, T1N0 tumors and in situ carcinoma are not eligible.

• If tumor extends below the EGJ junction into the proximal stomach, the bulk of the tumor must involve the esophagus or GE junction. The tumor must not extend more than 2 cm into the stomach (Siewert III). Gastric cancers with minor involvement of the GE junction or esophagus are not eligible.

• Age >18, no age upper limit unless patient would be unable to tolerate chemoradiotherapy.

• Have given written informed consent prior to any study-specific procedures.

• ECOG performance status 0-2.

• No prior thoracic radiotherapy allowed.

• Adequate hematological, renal, cardiac, hepatic and pulmonary functions.

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Adenocarcinoma
• Esophageal Cancer
• Esophageal Neoplasms

Intervention

Other:
• BIRC3
BIRC3-expression directed preoperative chemoradiotherapy in patients with resectable adenocarcinoma of the esophagus and EGJ

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Universitaria Integrata Verona

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	R0, number of patients achieving R0 resection.	number of patients achieving R0 resection.	3 years
Secondary	OS	overall survival	3 years
Secondary	DFS	disease free survival	3 years
Secondary	tumour response	tumour response evaluated either by Mandard's tumour regression grade	3 years
Secondary	safety profile	safety profile (incidence of = grade 3 adverse events using Common Terminology Criteria for Adverse Events - CTCAE - version 4.0).	3 years