ECX + Panitumumab vs. ECX Alone in Locally Advanced Gastric Cancer or Cancer of the Gastroesophageal Junction

PHASE2CompletedINTERVENTIONAL
Enrollment

171

Participants

Timeline

Start Date

October 31, 2010

Primary Completion Date

August 31, 2016

Study Completion Date

August 31, 2017

Conditions
Stomach NeoplasmsGastroesophageal Junction Neoplasms
Interventions
DRUG

Epirubicin, Cisplatin, Capecitabine, Panitumumab

Epirubicin: 50mg/m², administered as an intravenous bolus over 10min on day 1 of each 21 day cycle; Cisplatin: 60mg/m², administered as an intravenous infusion over 4h on day 1 of each 21 day cycle; Capecitabine: 625mg/m², administered orally twice daily on each day of each 21 day cycle; Panitumumab: 9 mg/kg bodyweight, administered IV by an infusion pump through a peripheral line or catheter over 60 min +-15 min on day 1 of each 21 day cycle. Number of Cycles: 3 neoadjuvant cycles and 3 adjuvant cycles until disease progression, withdrawal of consent or unacceptable toxicity develops.

DRUG

Epirubicin, Cisplatin, Capecitabine

Epirubicin: 50mg/m², administered as an intravenous bolus over 10min on day 1 of each 21 day cycle; Cisplatin: 60mg/m², administered as an intravenous infusion over 4h on day 1 of each 21 day cycle; Capecitabine: 625mg/m², administered orally twice daily on each day of each 21 day cycle. Number of Cycles: 3 neoadjuvant cycles and 3 adjuvant cycles until disease progression, withdrawal of consent or unacceptable toxicity develops.

Trial Locations (1)

10623

AIO-Studien gGmbH, Berlin

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Amgen

INDUSTRY

collaborator

WiSP Wissenschaftlicher Service Pharma GmbH

OTHER

lead

AIO-Studien-gGmbH

OTHER