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Adenocarcinoma of the Esophagogastric JunctionPhase 2MEMORINCT02287129

Evaluation for the Individualization of Therapy in Adenocarcinomas of the Gastroesophageal Junction

A Phase 2 study testing Oxaliplatin, Epirubicin and Capecitabine in people with Adenocarcinoma of the Esophagogastric Junction, run by Technical University of Munich at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Metabolic and Molecular Response evaluation for the individualization of therapy in adenocarcinomas of the gastroesophageal junction by evaluation of the R0 resection rate for patients with metabolically (ie, according to PET criteria) chemotherapy-resistant locally advanced AEG, who receive an intensified neoadjuvant… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Oxaliplatin, Epirubicin and Capecitabine
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
1 siteGermany
Study dates
5 Dec 2014to 7 Aug 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed AEG I-III
  • Potentially R0 - resectable AEG and primary tumor category UT2 -4
  • Functional operability : Exclusion of OP - limiting comorbidities
  • Intense FDG tracer uptake of the tumor during Baseline PET/CT examination and thus suitability for monitoring and early response prediction by FDG - PET ( [ 18F ] - FDG uptake in the tumor at baseline > 1.35 x liver SUV + 2 x standard deviation of the liver SUV)
  • Performance status (ECOG ) 0 or 1
  • Age : ≥ 18
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  • creatinine clearance > 60ml/min measured in a 24 h urine or calculated with the Cockgroft -Gault formula
  • bilirubin ≤ 1.5 times upper limit of normal , serum transaminases (GOT
  • / GPT ) ≤ 3 times ULN
  • leukocytes ≥ 3.5 g / l, platelet ≥ 100 g / l
  • Negative pregnancy test (determination of beta- HCG in urine or serum) in women of childbearing potential
  • A signed consent form after implementation of medical education

Who cannot join

  • Existing distant metastases (M1b)
  • Tumor infiltration into the tracheobronchial system
  • Previous radiotherapy targeted at the thorax
  • Lack of ability of the patient to adhere to the protocol rules
  • Manifest heart failure despite optimal medication> NYHA I
  • existing angina pectoris at rest or undergoing stress without clarification via interventional cardiology and / or myocardial infarction within the last 6 months
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  • Existing pregnancy or lactation
  • childbearing or fertility without using recognized safe methods of contraception
  • Coexisting other malignant diseases with the exception of a non-melanomatuous, localized skin tumor or carcinoma in situ of the cervix
  • absence of a signed consent form

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • 2nd department of the Medical Clinic of the Technical University Munich

    Munich, Bavaria, 81675

Other trials in Germany

About this study

Official title: Metabolic and Molecular Response Evaluation for the Individualization of Therapy in Adenocarcinomas of the Gastroesophageal Junction

Metabolic and Molecular Response evaluation for the individualization of therapy in adenocarcinomas of the gastroesophageal junction by evaluation of the R0 resection rate for patients with metabolically (ie, according to PET criteria) chemotherapy-resistant locally advanced AEG, who receive an intensified neoadjuvant chemoradiotherapy (INRCT). Additonal efforts will be done by investigation of molecular and metabolic biomarkers in relation to their predictive and prognostic value by correlating them with histopathologic responses and clinical outcome in an exploratory approach.

Read the detailed description

Adenocarcinomas of the esophagus and the esophagogastric junction (AEG) are clinically-topographically divided into subtypes I-III according to the Siewert classification and show an increased incidence. Neoadjuvant and/or perioperative chemotherapy or preoperative radiochemotherapy is well established in the management of AEG. However, a significant number of patients do not respond to preoperative chemotherapy, suffering from toxicity and facing a worse outcome due to lower R0 resection rates. Previous results from the MUNICON-1 and MUNICON-2 trials have shown that PET-based therapy individualization can be successfully integrated in neoadjuvant treatment algorithms.

Tumor-free resection edges (R0) constitute the greatest prognostic advantage in terms of overall survival. However, the R0 resection rates for patients who, according to early metabolic response evaluation, have not responded to the chemotherapy, have not been satisfactory, even after conversion to an - albeit moderate - radiochemotherapy in the MUNICON-2 trial. Thus, this patient population (so-called non responders) so far lack a beneficial neoadjuvant therapy modality.

Based on these results, the primary goal of MEMORI study is to evaluate the R0 resection rate for patients with metabolically (ie, according to PET criteria) chemotherapy-resistant locally advanced AEG, who receive an intensified neoadjuvant chemoradiotherapy (INRCT). Secondary it is planned to investigate molecular and metabolic biomarkers in relation to their predictive and prognostic value by correlating them with histopathologic responses and clinical outcome in an exploratory approach.

Keywords
Potentially R0 - resectable AEG and primary tumor category, Histologically confirmed AEG I-III, Functional operability, Intense FDG tracer uptake of the tumor

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OxaliplatinDrug

    Also called Oxaliplan

    130 mg/m2

  • EpirubicinDrug

    Also called Epi Teva

    50 mg/m2

  • CapecitabineDrug

    Also called Xeloda

    625 mg/m2

  • 5-FUDrug

    Also called 5-FU medac

    200 mg/m2

  • CarboplatinDrug

    Also called Carboplatin SUN

    2 mg/ml min

  • PaclitaxelDrug

    Also called Taxomedac

    50 mg/m2

  • radiationRadiation

    Also called intensitive neoadjuvant radiochemotherapy (INRCT)

    total dosage 41,4 Gy

  • BiopsyProcedure or surgery

    Also called esophagogastroduodenoscopy

    translational analysis

Study groups in NCT02287129
Study groupRoleWhat they receive
Non-ResponderExperimentalOxaliplatin Epirubicin Capecitabine 5-FU Carboplatin Paclitaxel Radiation Biopsy
Receives: Drug: Oxaliplatin; Drug: Epirubicin; Drug: Capecitabine; Drug: 5-FU; Drug: Carboplatin; Drug: Paclitaxel; Radiation: radiation; Procedure: Biopsy
ResponderActive comparatorOxaliplatin Epirubicin Capecitabine 5-FU Biopsy
Receives: Drug: Oxaliplatin; Drug: Epirubicin; Drug: Capecitabine; Drug: 5-FU; Procedure: Biopsy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. R0 resection rate

    R0 resection rate of patients suffering from metabolically (following PET criteria) chemotherapy-resistant, locally advanced AEG, who receive a more intensive neoadjuvant radio-chemotherapy (INRCT)

    Measured: 1 day of surgery (in between day 28 to day 43 after radio-chemotherapy)

Secondary outcomes (8)

  1. Regression

    Histological regression defined by Becker Criteria

    Measured: 1 day of surgery (in between day 28 to day 43 after radio-chemotherapy)

  2. Overall survival

    Overall survival defined as period from start of study to death (if necessary censored by end of follow-up period)

    Measured: from day 0 to follow up visit 6 (24 months after surgery)

  3. Disease-free survival

    Disease-free survival, defined as period from start of study to earlier occurring event: death or relapse until end of follow-up; Relapse will be separated into events of "local failure", "distant failure" and "local and distant failure"

    Measured: from day 0 to follow up visit 6 (24 months after surgery)

  4. QLQ-C30

    Quality of life, analyzed via EORTC QLQ-C30 questionnaires

    Measured: from day 0 to follow up visit 6 (24 months after surgery)

  5. Metabilic response rate

    Metabolic response rate under neoadjuvant chemotherapy

    Measured: from day 0 to one time point of time period day 14 to 28 after chemotherapy

  6. Translational analysis

    Translational analysis for identification of tumor determinants relevant for prognosis and therapy

    Measured: 1 day of surgery (in between day 28 to day 43 after radio-chemotherapy)

  7. Adverse Events

    Occurence of AEs

    Measured: from day 0 to follow up visit 6 (24 months after surgery)

  8. QLQ-OG25

    Quality of life, analyzed via EORTC QLQ-OG25 questionnaires

    Measured: from day 0 to follow up visit 6 (24 months after surgery)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Nov 2014 (estimated)
  2. Study start5 Dec 2014
  3. Primary completion7 Aug 2020
  4. Study completion7 Aug 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02287129
Sponsor's protocol ID
MEM-0000-SIV-0028-I
Acronym
MEMORI
Status last verified
Nov 2023
First submitted
7 Oct 2014
Last updated
28 Nov 2023
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Oxaliplatin, Epirubicin and Capecitabine in people with Adenocarcinoma of the Esophagogastric Junction, run by Technical University of Munich at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

R0 resection rate (time frame: 1 day of surgery (in between day 28 to day 43 after radio-chemotherapy)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02287129.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2023.

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