An Interventional Study of Avastin (Bevacizumab) in Patients With Advanced/Metastatic Epithelial Ovarian Cancer, Fallopian Tube Cancer or Primary Peritoneal Cancer
An Indian Multicentric, Open Label, Prospective Phase 4 Study of Bevacizumab in the Front Line Management of Advanced/Metastatic Epithelial Ovarian Cancer, Fallopian Tube Cancer or Primary Peritoneal Cancer in Real-life Clinical Practice
1 other identifier
interventional
100
1 country
13
Brief Summary
This multicenter prospective study will evaluate the safety and efficacy of Avastin (bevacizumab) in routine clinical practice in patients with advanced/metastatic epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer. Data will be collected from eligible patients until death, withdrawal of consent, loss to follow-up, or study closure.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Dec 2018
Longer than P75 for phase_4
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 27, 2013
CompletedFirst Posted
Study publicly available on registry
August 30, 2013
CompletedStudy Start
First participant enrolled
December 5, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 18, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 18, 2025
CompletedJune 26, 2025
June 1, 2025
6.5 years
August 27, 2013
June 25, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Safety: Incidence of adverse events
up to approximately 1.5 years
Secondary Outcomes (4)
Progression-free survival
up to approximately 1.5 years
Overall survival
up to approximately 1.5 years
Overall response rate (complete response + partial response)
up to approximately 1.5 years
Clinical benefit rate (complete response + partial response + stable disease)
up to approximately 1.5 years
Study Arms (1)
Cohort
EXPERIMENTALInterventions
Participants will receive five cycles of bevacizumab 15 mg/kg concurrently with six cycles of the standard chemotherapy every three weeks (q3w), followed by extended cycles of bevacizumab 15 mg/kg q3w as a single agent for additional 16 cycles. A total of 21 cycles of bevacizumab will be administered in this study.
Eligibility Criteria
You may qualify if:
- Prescribed to receive bevacizumab or already ongoing on treatment with bevacizumab for advanced/metastatic ovarian cancer, fallopian tube cancer or primary peritoneal cancer (FIGO Stage IIIb, IIIc and IV) according to routine clinical practice
You may not qualify if:
- Not eligible for treatment with bevacizumab according to the local prescribing information
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Manipal Hospital
Bangalore, Karnataka, 560017, India
HealthCare Global Enterprises Limited
Banglore, Karnataka, 560027, India
Marthwada Regional Cancer Center & Research Institute
Aurangabad, Maharashtra, 431001, India
MOC Cancer Care & Research Centre
Mumbai, Maharashtra, 400056, India
HCG NCHRI Cancer Center
Nagpur, Maharashtra, 440026, India
HCG Manavata Cancer Centre
Nashik, Maharashtra, 422002, India
Apex Wellness Hospital
Nashik, Maharashtra, 422009, India
Grant Medical Foundation, Ruby Hall Clinic
Pune, Maharashtra, 411001, India
Jehangir Clinical Development Centre Pvt. Ltd
Pune, Maharashtra, 411001, India
Sahyadri Speciality Hospital
Pune, Maharashtra, 411004, India
Rajiv Gandhi Cancer Inst.&Research Center
New Delhi, National Capital Territory of Delhi, 110085, India
Peerless Hospitex Hospital and Research Center Ltd.
Kolkata, West Bengal, 700094, India
MAX Balaji Hospital
Delhi, 110092, India
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 27, 2013
First Posted
August 30, 2013
Study Start
December 5, 2018
Primary Completion
June 18, 2025
Study Completion
June 18, 2025
Last Updated
June 26, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share