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

Primary Purpose

KRAS Wild Type, Resectable Type II Gastric Adenocarcinoma

Status
Terminated
Phase
Phase 2
Locations
Austria
Study Type
Interventional
Intervention
Epirubicine, Oxaliplatin, Capecitabine, Panitumumab
Sponsored by
Arbeitsgemeinschaft medikamentoese Tumortherapie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for KRAS Wild Type

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • LKH Feldkirch
  • KH Elisabethinen Linz
  • AKh Linz
  • Universitätsklinik für Innere Medizin III
  • Klinikum Kreuzschwestern Wels GmbH
  • St. Vinzenz Krankenhaus Betriebs GmbH

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

treatment

Arm Description

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

Outcomes

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

Full Information

First Posted
May 9, 2011
Last Updated
June 3, 2013
Sponsor
Arbeitsgemeinschaft medikamentoese Tumortherapie
Collaborators
Amgen
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1. Study Identification

Unique Protocol Identification Number
NCT01351038
Brief Title
Concurrent Induction Chemoimmunotherapy With Epirubicine, Oxaliplatin, Capecitabine and Panitumumab in KRAs Wild-type, Resectable Type II Gastric Adenocarcinoma
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Terminated
Why Stopped
REAL trial showed a significant difference in OS for reduced EOX and standard EOX
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Arbeitsgemeinschaft medikamentoese Tumortherapie
Collaborators
Amgen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
KRAS Wild Type, Resectable Type II Gastric Adenocarcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
43 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
treatment
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Epirubicine, Oxaliplatin, Capecitabine, Panitumumab
Intervention Description
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
Primary Outcome Measure Information:
Title
Efficacy
Description
Proportion of patients with T0 ant T1 disease after neoadjuvant combined chemoimmunotherapy
Title
Safety
Description
Proportion of patients with grade 4 diarrhea
Secondary Outcome Measure Information:
Title
Histopathological response
Description
rate of complete pathological response
Title
overall survival after one year
Title
Progression free survival after one year
Title
Proportion of patients completing 3 treatment cycles
Title
Safety
Description
NCI CTCAE v.3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
LKH Feldkirch
City
Feldkirch
ZIP/Postal Code
6807
Country
Austria
Facility Name
KH Elisabethinen Linz
City
Linz
ZIP/Postal Code
4010
Country
Austria
Facility Name
AKh Linz
City
Linz
ZIP/Postal Code
4021
Country
Austria
Facility Name
Universitätsklinik für Innere Medizin III
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Klinikum Kreuzschwestern Wels GmbH
City
Wels
ZIP/Postal Code
4600
Country
Austria
Facility Name
St. Vinzenz Krankenhaus Betriebs GmbH
City
Zams
ZIP/Postal Code
6511
Country
Austria

12. IPD Sharing Statement

Learn more about this trial

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

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