NCT03429816Completed
OPPOSITE: Outcome Prediction of Systemic Treatment in Esophagogastric Carcinoma
Molecular Outcome Prediction of Neoadjuvant Systemic Treatment in Esophagogastric Carcinoma
Source: ClinicalTrials.gov · Last updated 27 Mar 2025
Brief summary (registry, in English)
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; after neoadjuvant therapy tumor biopsies will be taken from different sites of the resection specimen. * Aim 1: Organoid cultures of pre-treatment tumor biopsies will be established and exposed to the same chemotherapy as the corresponding patient; in vitro response to treatment will be correlated with the in vivo response of patients. * Aim 2: Whole genome, methylome and RNA sequencing of tumors biopsies and organoids will be performed prior to as well as after systemic treatment. Histological and clinical outcome will be correlated with molecular subtypes.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 120 (actual)
- First submitted
- 5 Feb 2018
- Start date
- 15 Apr 2018
- Primary completion date
- 1 Nov 2021
- Lead sponsor
- University Hospital Heidelberg
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT03429816
What you commit to
- Study type: Interventional
- Participants enrolled: 120
- From 15 Apr 2018 to the primary completion date, 1 Nov 2021
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Documented history of congestive heart failure NYHA ≥III, myocardial infarction within the past 3 months before the start of neoadjuvant treatment
Other illness
- Known hypersensitivity against components of the neoadjuvant systemic 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.
Other
- Patients with distant metastasis
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital Dresden Coordinator of this site? Confirm its status | Dresden | Germany | Unknown status |
| National Center for Tumor Diseases, University Hospital Heidelberg Coordinator of this site? Confirm its status | Heidelberg | Germany | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.