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TerminatedNCT01351038Updated Jun 4, 2013

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

A Phase 2 interventional study of Epirubicine, Oxaliplatin, Capecitabine, Panitumumab in KRAS Wild Type and Resectable Type II Gastric Adenocarcinoma, sponsored by Arbeitsgemeinschaft medikamentoese Tumortherapie. Terminated at 6 sites in Austria. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2013-06-04.

Sponsored by Arbeitsgemeinschaft medikamentoese Tumortherapie · Phase 2, Interventional, and Treatment

Why this study was terminated
REAL trial showed a significant difference in OS for reduced EOX and standard EOX
Phase
Phase 2
Study type
Interventional
Enrollment
43
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
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Study 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.

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Conditions studied

  • KRAS Wild Type
  • Resectable Type II Gastric Adenocarcinoma

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In context

Adenocarcinoma

2,004 studies on the registry are indexed under Adenocarcinoma; 375 are open to participants now.

This study's planned enrollment of 43 is close to the median of 45 across 1,553 interventional studies indexed under Adenocarcinoma.

Browse Adenocarcinoma studies →

Lead sponsor

Arbeitsgemeinschaft medikamentoese Tumortherapie is the lead sponsor of 43 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
43 participants (estimated)

Study arms

  • 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

Interventions

  • DrugEpirubicine, 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

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What researchers measure

Primary outcomes

  1. Efficacy

    Proportion of patients with T0 ant T1 disease after neoadjuvant combined chemoimmunotherapy

  2. Safety

    Proportion of patients with grade 4 diarrhea

Secondary outcomes

  1. Histopathological response

    rate of complete pathological response

  2. overall survival after one year

  3. Progression free survival after one year

  4. Proportion of patients completing 3 treatment cycles

  5. Safety

    NCI CTCAE v.3

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Study locations

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

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 4, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01351038
Lead sponsor
Arbeitsgemeinschaft medikamentoese Tumortherapie
Collaborators
Amgen
First posted
May 10, 2011
Last update
Jun 4, 2013

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.

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