Maintenance Therapy With Sunitinib or Observation in Metastatic Pancreatic Cancer: a Phase II Randomized Trial.
OBJECTIVES:
- Compare the 6-month progression-free survival of patients with metastatic pancreatic
cancer without progression after 6 months of induction chemotherapy treated with
sunitinib malate as maintenance therapy vs observation.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms:
- Arm I: Patients receive oral sunitinib malate once daily for up to 6 months in the
absence of disease progression or unacceptable toxicity.
- Arm II: Patients undergo observation only.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
6-month progression-free survival
CT scan
every 2 months during therapy; every 3 months thereafter
No
Michele Reni, MD
Principal Investigator
Istituto Scientifico H. San Raffaele
Italy: Ministry of Health
CDR0000643632
NCT00967603
February 2008
January 2012
Name | Location |
---|