Clinical trial NCT01863693: An Observational Study of Avastin (Bevacizumab) in Combination With Chemotherapy as First-Line Treatment in Patients With Advanced Ovarian Cancer (OSCAR 1)
Official title: AN OBSERVATIONAL STUDY OF AVASTIN® (BEVACIZUMAB) AS FIRST LINE THERAPY IN PATIENTS WITH ADVANCED OVARIAN CANCER
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ovarian Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2013-05-29
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with advanced (FIGO stages IIIB, IIIC and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer undergoing first-line treatment with chemotherapy and Avastin

Brief summary: This multicenter, prospective, observational study will evaluate the safety and efficacy of Avastin (bevacizumab) in combination with chemotherapy as first-line treatment in patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer in routine clinical practice. Eligible patients will be followed for approximately 15 months.


Eligibility criteria: Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Advanced (FIGO stages IIIB, IIIC and IV) epithelial ovarian, fallopian tube or primary peritoneal cancer not previously treated with chemotherapy
* Initiating Avastin in combination with chemotherapy

Exclusion Criteria:

* Contraindications, warnings and precautions for use as specified in the Avastin Summary of Product Characteristics

Primary outcomes:
measure: Progression-free survival, defined as time from first administration of first-line therapy to documented disease progression
timeFrame: approximately 6 years
measure: Safety: Incidence of adverse events
timeFrame: approximately 6 years
Secondary outcomes:
measure: Overall survival, defined as time from first administration of first-line therapy to documented death
timeFrame: approximately 6 years
measure: Objective response rate, defined as percentage of patients with complete or partial response according to local assessments
timeFrame: approximately 6 years
measure: Quality of life: EQ-5D/EORTC questionnaires
timeFrame: approximately 6 years
measure: Dosage/schedule/duration of Avastin therapy
timeFrame: approximately 6 years
measure: Composition of first-line chemotherapy regimens: drugs/dosage/duration
timeFrame: approximately 6 years
Other outcomes:
Locations:
city: Bath
country: United Kingdom
facility: Royal United Hospital; Oncology Department
city: Birmingham
country: United Kingdom
facility: City Hospital
city: Bradford
country: United Kingdom
facility: Bradford Royal Infirmary; Oncology Department
city: Bristol
country: United Kingdom
facility: Bristol Haematology and Oncology Centre
city: Burton on Trent
country: United Kingdom
facility: Queen's Hospital; Oncology Department
city: Colchester
country: United Kingdom
facility: Essex County Hospital
city: Eastbourne
country: United Kingdom
facility: Eastborne District General Hospital
city: Exeter
country: United Kingdom
facility: Wonford Hospital; Oncology Department
city: Guildford
country: United Kingdom
facility: Royal Surrey County Hospital
city: Ipswich
country: United Kingdom
facility: Ipswich Hospital
city: Keighley
country: United Kingdom
facility: Airedale General Hospital; Research Office Ward 12
city: Leeds
country: United Kingdom
facility: St James University Hospital
city: London
country: United Kingdom
facility: Royal Marsden Hospital - London
city: Maidstone
country: United Kingdom
facility: Maidstone Hospital; Kent Oncology Centre
city: Manchester
country: United Kingdom
facility: Christie Hospital Nhs Trust; Medical Oncology
city: Middlesborough
country: United Kingdom
facility: The James Cook University Hospital
city: Middlesex
country: United Kingdom
facility: Mount Vernon Hospital
city: Newport
country: United Kingdom
facility: St Mary's Hospital
city: Nottingham
country: United Kingdom
facility: City Campus; Academic Unit of Oncology
city: Portsmouth
country: United Kingdom
facility: Queen Alexandra Hospital; Portsmouth Haematology & Oncology Centre, Level B
city: Sheffield
country: United Kingdom
facility: Weston Park Hospital; Cancer Clinical Trials Centre
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
city: Stoke-on-Trent
country: United Kingdom
facility: City General Hospital
city: Sutton
country: United Kingdom
facility: The Royal Marsden Hospital
city: Swansea
country: United Kingdom
facility: Singleton Hospital; Oncology
city: Torquay
country: United Kingdom
facility: Torbay Hospital; Oncology Department
city: Truro
country: United Kingdom
facility: Royal Cornwall Hospital
city: Wirral
country: United Kingdom
facility: The Clatterbridge Cancer Centre NHS Foundation Trust
city: Wolverhampton
country: United Kingdom
facility: New Cross Hospital; Deansley Centre
city: York
country: United Kingdom
facility: The York Hospital
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Hall M, Bertelli G, Li L, Green C, Chan S, Yeoh CC, Hasan J, Jones R, Ograbek A, Perren TJ. Role of front-line bevacizumab in advanced ovarian cancer: the OSCAR study. Int J Gynecol Cancer. 2020 Feb;30(2):213-220. doi: 10.1136/ijgc-2019-000512. Epub 2019 Nov 27.