Concurrent Induction Chemoimmunotherapy With Epirubicine, Oxaliplatin, Capecitabine and Panitumumab in KRAs Wild-type, Resectable Type II Gastric Adenocarcinoma

June 3, 2013 updated by: Arbeitsgemeinschaft medikamentoese Tumortherapie

A Two Stage Multicenter Phase II Trial of Concurrent Induction Chemoimmunotherapy With Epirubicine, Oxaliplatin, Capecitabine and Panitumumab in KRAs Wild-type, Resectable Type II Gastric Adenocarcinoma

This is an open label, multicenter, single-arm phase II trial with primary eqirubicine-oxaliplatin-capecitabine chemotherapy and concurrent Pmab in patients with resectable, histologically proven gastric or esophageal cancer.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

43

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Feldkirch, Austria, 6807
        • LKH Feldkirch
      • Linz, Austria, 4021
        • AKh Linz
      • Linz, Austria, 4010
        • KH Elisabethinen Linz
      • Salzburg, Austria, 5020
        • Universitätsklinik für Innere Medizin III
      • Wels, Austria, 4600
        • Klinikum Kreuzschwestern Wels GmbH
      • Zams, Austria, 6511
        • St. Vinzenz Krankenhaus Betriebs GmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Untreated, histologically confirmed, KRAS wild type, resectable gastric or esophageal adenocarcinoma
  • T2-4 NX M0 disease
  • ECOG performance status 0-1
  • adequate hematological status
  • adequate renal function
  • adequate hepatic function
  • adequate metabolic function

Exclusion Criteria:

  • pregnant or breast feeding women
  • previous malignancy other than gastric cancer in the last 5 years except curatively treated basal cell carcinoma of the skin and/or in situ carcinoma of the cervix
  • arterial or venous thromboembolism within 6 months before enrollment
  • clinically significant cardiovascular disease within 1 year before enrollment
  • history of interstitial lung disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: treatment
3 cycles(repeated q21d) Epirubicine 50mg/m² i.v. d1 Oxaliplatin 100mg/m² i.v. d1 Capecitabine 500mg/m² bid d1-d21 Panitumumab 9mg/kg i.v. d1
Drug: Epirubicine, Oxaliplatin, Capecitabine, Panitumumab
3 cycles (repeated q 21d) Epirubicine 50mg/m² i.v. d1 Oxaliplatin 100mg/m² i.v. d1 Panitumumab 9mg/kg i.v. d1 Capecitabine 500mg/m² bid d1-21

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Efficacy
Proportion of patients with T0 ant T1 disease after neoadjuvant combined chemoimmunotherapy
Safety
Proportion of patients with grade 4 diarrhea

Secondary Outcome Measures

Outcome Measure
Measure Description
Histopathological response
rate of complete pathological response
overall survival after one year
Progression free survival after one year
Proportion of patients completing 3 treatment cycles
Safety
NCI CTCAE v.3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arbeitsgemeinschaft medikamentoese Tumortherapie

Collaborators

Amgen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

May 9, 2011

First Submitted That Met QC Criteria

May 9, 2011

First Posted (Estimate)

May 10, 2011

Study Record Updates

Last Update Posted (Estimate)

June 4, 2013

Last Update Submitted That Met QC Criteria

June 3, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AGMT Gastric-4

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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