KRAS Wild Type Clinical Trial
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
| NCT number | NCT01351038 |
| Other study ID # | AGMT Gastric-4 |
| Secondary ID | |
| Status | Terminated |
| Phase | Phase 2 |
| First received | May 9, 2011 |
| Last updated | June 3, 2013 |
| Verified date | June 2013 |
| Source | Arbeitsgemeinschaft medikamentoese Tumortherapie |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Austria: Ethikkommission |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 43 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 65 Years |
| Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Austria | LKH Feldkirch | Feldkirch | |
| Austria | AKh Linz | Linz | |
| Austria | KH Elisabethinen Linz | Linz | |
| Austria | Universitätsklinik für Innere Medizin III | Salzburg | |
| Austria | Klinikum Kreuzschwestern Wels GmbH | Wels | |
| Austria | St. Vinzenz Krankenhaus Betriebs GmbH | Zams |
| Lead Sponsor | Collaborator |
|---|---|
| Arbeitsgemeinschaft medikamentoese Tumortherapie | Amgen |
Austria,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Efficacy | Proportion of patients with T0 ant T1 disease after neoadjuvant combined chemoimmunotherapy | No | |
| Primary | Safety | Proportion of patients with grade 4 diarrhea | Yes | |
| Secondary | Histopathological response | rate of complete pathological response | No | |
| Secondary | overall survival after one year | |||
| Secondary | Progression free survival after one year | |||
| Secondary | Proportion of patients completing 3 treatment cycles | |||
| Secondary | Safety | NCI CTCAE v.3 |