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

This study has been terminated.
(REAL trial showed a significant difference in OS for reduced EOX and standard EOX)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01351038
First Posted: May 10, 2011
Last Update Posted: June 4, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Amgen
Information provided by:
Arbeitsgemeinschaft medikamentoese Tumortherapie
  Purpose
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.

Condition Intervention Phase
KRAS Wild Type Resectable Type II Gastric Adenocarcinoma Drug: Epirubicine, Oxaliplatin, Capecitabine, Panitumumab Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Arbeitsgemeinschaft medikamentoese Tumortherapie:

Primary Outcome Measures:
  • Efficacy
    Proportion of patients with T0 ant T1 disease after neoadjuvant combined chemoimmunotherapy

  • Safety
    Proportion of patients with grade 4 diarrhea


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 43
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01351038


Locations
Austria
LKH Feldkirch
Feldkirch, Austria, 6807
KH Elisabethinen Linz
Linz, Austria, 4010
AKh Linz
Linz, Austria, 4021
Universitätsklinik für Innere Medizin III
Salzburg, Austria, 5020
Klinikum Kreuzschwestern Wels GmbH
Wels, Austria, 4600
St. Vinzenz Krankenhaus Betriebs GmbH
Zams, Austria, 6511
Sponsors and Collaborators
Arbeitsgemeinschaft medikamentoese Tumortherapie
Amgen
  More Information

Responsible Party: Dr. Daniela Wolkersdorfer, Arbeitsgemeinschaft für medikamentöse Tumortherapie GmbH
ClinicalTrials.gov Identifier: NCT01351038     History of Changes
Other Study ID Numbers: AGMT Gastric-4
First Submitted: May 9, 2011
First Posted: May 10, 2011
Last Update Posted: June 4, 2013
Last Verified: June 2013

Additional relevant MeSH terms:
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Capecitabine
Oxaliplatin
Epirubicin
Antibodies, Monoclonal
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors