AURELIA: A Multi-center, Open-label, Randomised, Two-arm Phase III Trial of the Effect on Progression Free Survival of Bevacizumab Plus Chemotherapy Versus Chemotherapy Alone in Patients With Platinum-resistant, Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer
Phase 3
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Female
Ovarian Cancer
Female
Ovarian Cancer
Trial Information
AURELIA: A Multi-center, Open-label, Randomised, Two-arm Phase III Trial of the Effect on Progression Free Survival of Bevacizumab Plus Chemotherapy Versus Chemotherapy Alone in Patients With Platinum-resistant, Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer
Inclusion Criteria:
- female patients, >/=18 years of age
- epithelial ovarian, fallopian tube or primary peritoneal cancer
- platinum-resistant disease (disease progression within <6 months of platinum therapy)
- EOCG performance status of 0-2
Exclusion Criteria:
- non-epithelial tumours
- ovarian tumours with low malignant potential
- previous treatment with >2 chemotherapy regimens
- prior radiotherapy to the pelvis or abdomen
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression-free survival
Outcome Time Frame:
tumour assessments every 8-9 weeks
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
Spain: Ministry of Health
Study ID:
MO22224
NCT ID:
NCT00976911
Start Date:
October 2009
Completion Date:
December 2013
Related Keywords:
- Ovarian Cancer
- Ovarian Neoplasms
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