An Observational Study of Avastin (Bevacizumab) in Combination With Chemotherapy as First-Line Treatment in Patients With Advanced Ovarian Cancer (OSCAR 1)

September 13, 2018 updated by: Hoffmann-La Roche

AN OBSERVATIONAL STUDY OF AVASTIN® (BEVACIZUMAB) AS FIRST LINE THERAPY IN PATIENTS WITH ADVANCED OVARIAN CANCER

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Bath, United Kingdom, BA1 3NG
        • Royal United Hospital; Oncology Department
      • Birmingham, United Kingdom, B18 7QH
        • City Hospital
      • Bradford, United Kingdom, BD9 6RJ
        • Bradford Royal Infirmary; Oncology Department
      • Bristol, United Kingdom, BS2 8ED
        • Bristol Haematology and Oncology Centre
      • Burton on Trent, United Kingdom, DE13 0RB
        • Queen's Hospital; Oncology Department
      • Colchester, United Kingdom, CO3 3NB
        • Essex County Hospital
      • Eastbourne, United Kingdom, BN21 2UD
        • Eastborne District General Hospital
      • Exeter, United Kingdom, EX2 5DW
        • Wonford Hospital; Oncology Department
      • Guildford, United Kingdom, GU2 7XX
        • Royal Surrey County Hospital
      • Ipswich, United Kingdom, IP4 5PD
        • Ipswich Hospital
      • Keighley, United Kingdom, BD20 6TD
        • Airedale General Hospital; Research Office Ward 12
      • Leeds, United Kingdom, LS9 7TF
        • St James University Hospital
      • London, United Kingdom, SW3 6JJ
        • Royal Marsden Hospital - London
      • Maidstone, United Kingdom, ME16 0FS
        • Maidstone Hospital; Kent Oncology Centre
      • Manchester, United Kingdom, M2O 4BX
        • Christie Hospital Nhs Trust; Medical Oncology
      • Middlesborough, United Kingdom, TS4 3BW
        • The James Cook University Hospital
      • Middlesex, United Kingdom, HA6 2RN
        • Mount Vernon Hospital
      • Newport, United Kingdom, PO30 5TG
        • St Mary's Hospital
      • Nottingham, United Kingdom, NG5 1PB
        • City Campus; Academic Unit of Oncology
      • Portsmouth, United Kingdom, PO6 3LY
        • Queen Alexandra Hospital; Portsmouth Haematology & Oncology Centre, Level B
      • Sheffield, United Kingdom, S10 2SJ
        • Weston Park Hospital; Cancer Clinical Trials Centre
      • Southampton, United Kingdom, SO16 6YD
        • Southampton General Hospital
      • Stoke-on-Trent, United Kingdom, ST4 6QG
        • City General Hospital
      • Sutton, United Kingdom, SM2 5PT
        • The Royal Marsden Hospital
      • Swansea, United Kingdom, SA2 8QA
        • Singleton Hospital; Oncology
      • Torquay, United Kingdom, TQ27AA
        • Torbay Hospital; Oncology Department
      • Truro, United Kingdom, TR1 3LQ
        • Royal Cornwall Hospital
      • Wirral, United Kingdom, L63 4JY
        • The Clatterbridge Cancer Centre NHS Foundation Trust
      • Wolverhampton, United Kingdom, WV10 0QP
        • New Cross Hospital; Deansley Centre
      • York, United Kingdom, YO31 8HE
        • The York Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival, defined as time from first administration of first-line therapy to documented disease progression
Time Frame: approximately 6 years
approximately 6 years
Safety: Incidence of adverse events
Time Frame: approximately 6 years
approximately 6 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival, defined as time from first administration of first-line therapy to documented death
Time Frame: approximately 6 years
approximately 6 years
Objective response rate, defined as percentage of patients with complete or partial response according to local assessments
Time Frame: approximately 6 years
approximately 6 years
Quality of life: EQ-5D/EORTC questionnaires
Time Frame: approximately 6 years
approximately 6 years
Dosage/schedule/duration of Avastin therapy
Time Frame: approximately 6 years
approximately 6 years
Composition of first-line chemotherapy regimens: drugs/dosage/duration
Time Frame: approximately 6 years
approximately 6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 10, 2013

Primary Completion (Actual)

June 15, 2018

Study Completion (Actual)

June 15, 2018

Study Registration Dates

First Submitted

May 23, 2013

First Submitted That Met QC Criteria

May 23, 2013

First Posted (Estimate)

May 29, 2013

Study Record Updates

Last Update Posted (Actual)

September 17, 2018

Last Update Submitted That Met QC Criteria

September 13, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML28570

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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