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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


Phase 2
18 Years
65 Years
Not Enrolling
Both
KRAS Wild Type, Resectable Type II Gastric Adenocarcinoma

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Efficacy

Outcome Description:

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

Safety Issue:

No

Authority:

Austria: Ethikkommission

Study ID:

AGMT Gastric-4

NCT ID:

NCT01351038

Start Date:

Completion Date:

Related Keywords:

  • KRAS Wild Type
  • Resectable Type II Gastric Adenocarcinoma
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Stomach Neoplasms

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