Clinical trial NCT01932125: An Interventional Study of Avastin (Bevacizumab) in Patients With Advanced/Metastatic Epithelial Ovarian Cancer, Fallopian Tube Cancer or Primary Peritoneal Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Ovarian Neoplasms
Peritoneal Neoplasms
Fallopian Tube Neoplasms
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2013-08-30
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Not eligible for treatment with bevacizumab according to the local prescribing information

Primary outcomes:
measure: Safety: Incidence of adverse events
timeFrame: up to approximately 1.5 years
Secondary outcomes:
measure: Progression-free survival
timeFrame: up to approximately 1.5 years
measure: Overall survival
timeFrame: up to approximately 1.5 years
measure: Overall response rate (complete response + partial response)
timeFrame: up to approximately 1.5 years
measure: Clinical benefit rate (complete response + partial response + stable disease)
timeFrame: up to approximately 1.5 years
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Rajiv Gandhi Cancer Inst.&Research Center
state: Delhi
city: Bangalore
country: India
facility: Manipal Hospital
state: Karnataka
city: Banglore
country: India
facility: HealthCare Global Enterprises Limited
state: Karnataka
city: Aurangabad
country: India
facility: Marthwada Regional Cancer Center & Research Institute
state: Maharashtra
city: Mumbai
country: India
facility: MOC Cancer Care & Research Centre
state: Maharashtra
city: Nagpur
country: India
facility: HCG NCHRI Cancer Center
state: Maharashtra
city: Nashik
country: India
facility: HCG Manavata Cancer Centre
state: Maharashtra
city: Nashik
country: India
facility: Apex Wellness Hospital
state: Maharashtra
city: Pune
country: India
facility: Grant Medical Foundation, Ruby Hall Clinic
state: Maharashtra
city: Pune
country: India
facility: Jehangir Clinical Development Centre Pvt. Ltd
state: Maharashtra
city: Pune
country: India
facility: Sahyadri Speciality Hospital
state: Maharashtra
city: Kolkata
country: India
facility: Peerless Hospitex Hospital and Research Center Ltd.
state: WEST Bengal
city: Delhi
country: India
facility: MAX Balaji Hospital
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: