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OPPOSITE: Outcome Prediction Of Systemic Treatment in Esophagogastric Carcinoma (OPPOSITE)

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ClinicalTrials.gov Identifier: NCT03429816
Recruitment Status : Recruiting
First Posted : February 12, 2018
Last Update Posted : March 25, 2021
Sponsor:
Collaborators:
University Hospital Dresden
German Cancer Research Center
Information provided by (Responsible Party):
Georg Martin Haag, University Hospital Heidelberg

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; 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.

Condition or disease Intervention/treatment Phase
Gastric Neoplasm Gastroesophageal Junction Adenocarcinoma Esophageal Adenocarcinoma Gastric Adenocarcinoma Esophageal Neoplasms Procedure: Biopsy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Molecular Outcome Prediction of Neoadjuvant Systemic Treatment in Esophagogastric Carcinoma
Actual Study Start Date : April 15, 2018
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arm Intervention/treatment
Experimental: Interventional Arm

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.

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.

Whole genome, methylome and RNA sequencing of tumors biopsies and organoids will be performed prior to as well as after systemic treatment.

Procedure: Biopsy
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 Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03429816


Contacts
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Contact: Georg Martin Haag +49 6221 56 8819 NCT.Patientenzentrum@med.uni-heidelberg.de

Locations
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Germany
University Hospital Dresden Recruiting
Dresden, Germany
Contact: Studienzentrum    +49(0)351 458 18354    Daniel.Stange@uniklinikum-dresden.de   
National Center for Tumor Diseases, University Hospital Heidelberg Recruiting
Heidelberg, Germany
Contact: Georg Martin Haag       NCT.Patientenzentrum@med.uni-heidelberg.de   
Sponsors and Collaborators
University Hospital Heidelberg
University Hospital Dresden
German Cancer Research Center
Investigators
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Principal Investigator: Georg Martin Haag NCT, University Hospital Heidelberg
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Responsible Party: Georg Martin Haag, NCT, Dep. Medical Oncology, University Hospital Heidelberg
ClinicalTrials.gov Identifier: NCT03429816    
Other Study ID Numbers: OPPOSITE
First Posted: February 12, 2018    Key Record Dates
Last Update Posted: March 25, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms
Adenocarcinoma
Esophageal Neoplasms
Stomach Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Stomach Diseases