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Completed

NCT Number: NCT03429816

OPPOSITE: Outcome Prediction of Systemic Treatment in Esophagogastric Carcinoma

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Dresden, Dresden, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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 criteria

  • 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.

Treatment and study plan

Biopsy

Procedure

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.

Primary outcomes

  1. Aim 1: Correlation of in-vitro response in the organoid model with histological regression in the resected tumor

    Time frame: 1 year

    Correlation of in-vitro response to cytotoxic chemotherapy in the patient-derived organoid model with histological regression in the resected specimen and analysis of reliability of this organoid model in predicting patients' response to neoadjuvant chemotherapy.

  2. Aim 2: Correlation of molecular subtypes with histological response after neoadjuvant therapy in patients

    Time frame: 1 year

    Prognostic impact of the molecular subtypes on histological response to neoadjuvant chemotherapy in patients will be modeled using the logistic regression.

Secondary outcomes

  1. Aim 1: Correlation of in-vitro response in the organoid model with relapse-free survival

    Time frame: maximum 5 years

    The possible prognostic impact of in-vitro response in the organoid model on relapse-free survival will be investigated using the Cox proportional hazards models.

  2. Aim 2: Correlation of molecular subtypes with relapse-free survival

    Time frame: maximum 5 years

    The possible prognostic impact of molecular subtypes on relapse-free survival will be investigated using the Cox proportional hazards models.

Other outcomes

  1. Aim 1: Correlation of in-vitro response in the organoid model with overall survival

    Time frame: maximum 5 years

    The possible prognostic impact of in-vitro response in the organoid model on overall survival will be investigated using the Cox proportional hazards models.

  2. Aim 2: Correlation of molecular subtypes with overall survival

    Time frame: maximum 5 years

    The possible prognostic impact of molecular subtypes on overall survival will be investigated using the Cox proportional hazards models.

Sponsors and collaborators

Lead sponsor

University Hospital Heidelberg

Other

Collaborators

  • German Cancer Research Center
  • University Hospital Dresden

Registry information

Official study title

Molecular Outcome Prediction of Neoadjuvant Systemic Treatment in Esophagogastric Carcinoma

Acronym: OPPOSITE

Important dates

Study start
2018
Primary completion
2021
Study completion
2023
First posted
Feb 12, 2018
Registry last updated
Mar 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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