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

Arbeitsgemeinschaft medikamentoese Tumortherapie

Status and phase: Terminated; Phase 2

Conditions: Resectable Type II Gastric Adenocarcinoma; KRAS Wild Type

Treatments: Drug: Epirubicine, Oxaliplatin, Capecitabine, Panitumumab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01351038

AGMT Gastric-4

Details and patient eligibility

About

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.

Enrollment: 43 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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43 participants in 1 patient group

treatment

Experimental group

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

Treatment:

Drug: Epirubicine, Oxaliplatin, Capecitabine, Panitumumab