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JOURNAL ONKOLOGIE – STUDIE
OPPOSITE

OPPOSITE: Outcome Prediction Of Systemic Treatment in Esophagogastric Carcinoma

Rekrutierend

NCT-Nummer:
NCT03429816

Studienbeginn:
April 2018

Letztes Update:
25.03.2021

Wirkstoff:
-

Indikation (Clinical Trials):
Neoplasms, Adenocarcinoma, Esophageal Neoplasms, Stomach Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
University Hospital Heidelberg

Collaborator:
University Hospital Dresden, German Cancer Research Center,

Studienleiter

Georg Martin Haag
Principal Investigator
NCT, University Hospital Heidelberg

Kontakt

Georg Martin Haag
Kontakt:
Phone: +49 6221 56 8819
E-Mail: NCT.Patientenzentrum@med.uni-heidelberg.de
» Kontaktdaten anzeigen

Studienlocations
(2 von 2)

National Center for Tumor Diseases, University Hospital Heidelberg
Heidelberg
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Georg Martin Haag
E-Mail: NCT.Patientenzentrum@med.uni-heidelberg.de
» Ansprechpartner anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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.

Studien-Rationale

Primary outcome:

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:

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.

Geprüfte Regime

  • 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.

Quelle: ClinicalTrials.gov


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