ClinicalTrials.gg
CompletedNCT03429816OPPOSITEUpdated Mar 27, 2025

OPPOSITE: Outcome Prediction of Systemic Treatment in Esophagogastric Carcinoma

An interventional study of Biopsy in Gastric Neoplasm, Gastroesophageal Junction Adenocarcinoma and Esophageal Adenocarcinoma, sponsored by University Hospital Heidelberg. Completed at 2 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-27.

Sponsored by University Hospital Heidelberg · Not applicable, Interventional, and Diagnostic

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Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-15

Among 161 studies in Stomach Neoplasms with a site in Germany — 25 open to participants now, 41 under way, 13 of them phase 3. Stomach Neoplasms · Germany.

Enrollment
78th of 138
120 · median 181
Started
2018
with 7 others
No phase
10 of 161
3 open now
Registered
95th of 161
by date

Among the 161 studies in Stomach Neoplasms with a site in Germany, this one is the 78th largest by enrollment of the 138 interventional ones that give a count, is one of 8 that started in 2018, is one of 10 with no phase, and was the 95th registered.

Stomach Neoplasms

3,401 studies on the registry are indexed under Stomach Neoplasms; 993 are open to participants now.

Browse Stomach Neoplasms studies →

Open to participants now

25 of the 161 studies in Stomach Neoplasms with a site in Germany are open now. Recruiting first, the newest first:

20 more — sign in →

All 25 open studies →

A study can be open while its sites in Germany have not opened yet or have stopped. Only those recruiting at a site in Germany →

Who these studies take

Of the 704 Stomach Neoplasms studies recruiting now, 376 (53%) set no upper age limit and 194 (28%) stop at 75 or younger; 28 take children under 18; 69 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study 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.
03

Conditions studied

  • Gastric Neoplasm
  • Gastroesophageal Junction Adenocarcinoma
  • Esophageal Adenocarcinoma
  • Gastric Adenocarcinoma
  • Esophageal Neoplasms
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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:

  • -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 by CT or MRI of thorax and abdomen, and optionally bone scan (if osseous lesions are suspected due to clinical signs)

Exclusion criteria

Exclusion Criteria:

  • Patients with distant
  • Known against components of the systemic treatment
  • Documented history of congestive heart failure ≥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 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.
Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Adjuvant and neoadjuvant

Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumor. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
120 participants (actual)

Study arms

  • 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

Interventions

  • ProcedureBiopsy

    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.

06

What researchers measure

Primary outcomes

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

    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.

    Time frame: 1 year

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

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

    Time frame: 1 year

Secondary outcomes

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

    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.

    Time frame: maximum 5 years

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

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

    Time frame: maximum 5 years

Other outcomes

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

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

    Time frame: maximum 5 years

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

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

    Time frame: maximum 5 years

07

Study locations

2 sites
  • University Hospital Dresden
    Dresden, Germany
  • National Center for Tumor Diseases, University Hospital Heidelberg
    Heidelberg, Germany
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2018 to primary completion in Nov 2021, 42 months.

Of 356 non-industry interventional studies with no phase under Stomach Neoplasms, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 66. This study's 42 months is above that.

Counting every sponsor, half of 367 studies reached it within 36 months; a quarter within 17 and three quarters within 63.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 5, 2018
First posted
Feb 12, 2018
StartActual
Apr 15, 2018
Primary completionActual
Nov 1, 2021
CompletionActual
Nov 30, 2023
Last update
Mar 27, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 27, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03429816
Collaborators
University Hospital Dresden, German Cancer Research Center
Responsible party
Georg Martin Haag (NCT, Dep. Medical Oncology, University Hospital Heidelberg) — Principal investigator
First posted
Feb 12, 2018
Start date
Apr 15, 2018
Primary completion
Nov 1, 2021
Completion
Nov 30, 2023
Last update
Mar 27, 2025

Study contacts

Georg Martin Haag
principal investigator · NCT, University Hospital Heidelberg

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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