Cisplatin and 5-FU +/- Panitumumab for Patients With Nonresectable,Advanced or Metastatic Esophageal Squamous Cell Cancer
Status:
Terminated
Trial end date:
2017-05-01
Target enrollment:
Participant gender:
Summary
More than 50% of patients with esophageal cancer have locally advanced or metastatic disease
at presentation. The use of chemotherapy for this patient group is increasing with the
intention of local and distant tumor control, improving quality of life and prolongation of
survival.
Previous data suggested not only that EGFR antibody targeted therapy may be safely combined
with cisplatin and 5-FU but also may increase the efficacy of standard cisplatin / 5-FU
regime.
In the present study, patients with nonresectable, advanced or metastatic esophageal squamous
cell cancer (ESCC) will receive chemotherapy or chemotherapy plus panitumumab every 3 weeks
until disease progression occurs.
The primary objective is to demonstrate superiority of 5-FU, Cisplatin and Panitumumab over
5-FU and Cisplatin alone in terms of overall survival in esophageal cancer.
Phase:
Phase 3
Details
Lead Sponsor:
AIO-Studien-gGmbH
Collaborators:
Amgen Assign Clinical Research GmbH Assign Data Management and Biostatistics GmbH