Status:
COMPLETED
OPPOSITE: Outcome Prediction of Systemic Treatment in Esophagogastric Carcinoma
Lead Sponsor:
University Hospital Heidelberg
Collaborating Sponsors:
University Hospital Dresden
German Cancer Research Center
Conditions:
Gastric Neoplasm
Gastroesophageal Junction Adenocarcinoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Patients with locally advanced, resectable gastric or esophagogastric junction adenocarcinoma will receive a biopsy of the primary tumor, followed by standard-of care neoadjuvant systemic treatment; a...
Eligibility Criteria
Inclusion
- Histologically confirmed, resectable adenocarcinoma of the GEJ (type I-III) or the stomach (cT2, cT3,cT4, any cN category, M0), or any cT cN+ M0 with the following specifications:
- ECOG-Score ≤ 2
- Patient is fit to undergo surgery (either subtotal or total gastrectomy, transhiatal or abdominothoracic esophagectomy)
- No preceding cytotoxic or targeted therapy
- No prior partial or complete tumor resection
- Exclusion of distant metastasis by CT or MRI of thorax and abdomen, and optionally bone scan (if osseous lesions are suspected due to clinical signs)
Exclusion
- Patients with distant metastasis
- Known hypersensitivity against components of the neoadjuvant systemic treatment
- Documented history of congestive heart failure NYHA ≥III, myocardial infarction within the past 3 months before the start of neoadjuvant treatment
- Uncontrollable high-risk cardiac arrhythmia, e.g. significant ventricular arrhythmia
- Past or current history of other malignancies not curatively treated and without evidence of disease for more than 5 years, except for curatively treated early stage cancers such as basal cell carcinoma of the skin and in situ carcinoma of the cervix or the bladder.
Key Trial Info
Start Date :
April 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2023
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT03429816
Start Date
April 15 2018
End Date
November 30 2023
Last Update
March 27 2025
Active Locations (2)
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1
University Hospital Dresden
Dresden, Germany
2
National Center for Tumor Diseases, University Hospital Heidelberg
Heidelberg, Germany