NCT01351038TerminatedPhase 2
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
Arbeitsgemeinschaft medikamentoese Tumortherapie6 sites in 1 country43 target enrollmentStarted: May 10, 2011Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- Enrollment
- 43
- Locations
- 6
- Primary Endpoint
- Efficacy
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- 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
- •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
Arms & Interventions
treatment
Experimental
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: Epirubicine, Oxaliplatin, Capecitabine, Panitumumab (Drug)
Outcomes
Primary Outcomes
Efficacy
Proportion of patients with T0 ant T1 disease after neoadjuvant combined chemoimmunotherapy
Safety
Proportion of patients with grade 4 diarrhea
Secondary Outcomes
- Histopathological response
- overall survival after one year
- Progression free survival after one year
- Proportion of patients completing 3 treatment cycles
- Safety
Investigators
Study Sites (6)
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