JOURNAL ONKOLOGIE – STUDIE
OPPOSITE
Georg Martin Haag
Principal Investigator
NCT, University Hospital Heidelberg
Georg Martin Haag
Kontakt:
Phone: +49 6221 56 8819
E-Mail: NCT.Patientenzentrum@med.uni-heidelberg.de» Kontaktdaten anzeigen
Studienlocations
University Hospital Dresden
Dresden
(Sachsen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Studienzentrum
Phone: +49(0)351 458 18354
E-Mail: Daniel.Stange@uniklinikum-dresden.de» Ansprechpartner anzeigen 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
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.
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.
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.
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
Principal Investigator
NCT, University Hospital Heidelberg
Kontakt
Kontakt:
Phone: +49 6221 56 8819
E-Mail: NCT.Patientenzentrum@med.uni-heidelberg.de» Kontaktdaten anzeigen
Studienlocations
(2 von 2)
Dresden
(Sachsen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Studienzentrum
Phone: +49(0)351 458 18354
E-Mail: Daniel.Stange@uniklinikum-dresden.de» Ansprechpartner anzeigen
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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