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Ovarian CancerNCT01863693

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

An observational study of Ovarian Cancer, run by Hoffmann-La Roche at 30 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Cancer
How many people
300 participants
Where
30 sitesUnited Kingdom
Study dates
10 May 2013to 15 Jun 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

30 sites in 1 country.

30 sites in 1 country

United Kingdom30 sites

  • Royal United Hospital; Oncology Department

    Bath, BA1 3NG

  • City Hospital

    Birmingham, B18 7QH

  • Bradford Royal Infirmary; Oncology Department

    Bradford, BD9 6RJ

  • Bristol Haematology and Oncology Centre

    Bristol, BS2 8ED

  • Queen's Hospital; Oncology Department

    Burton-on-Trent, DE13 0RB

  • Essex County Hospital

    Colchester, CO3 3NB

  • Eastborne District General Hospital

    Eastbourne, BN21 2UD

  • Wonford Hospital; Oncology Department

    Exeter, EX2 5DW

  • Royal Surrey County Hospital

    Guildford, GU2 7XX

  • Ipswich Hospital

    Ipswich, IP4 5PD

  • Airedale General Hospital; Research Office Ward 12

    Keighley, BD20 6TD

  • St James University Hospital

    Leeds, LS9 7TF

  • Royal Marsden Hospital - London

    London, SW3 6JJ

  • Maidstone Hospital; Kent Oncology Centre

    Maidstone, ME16 0FS

  • Christie Hospital Nhs Trust; Medical Oncology

    Manchester, M2O 4BX

  • The Clatterbridge Cancer Centre NHS Foundation Trust

    Metropolitan Borough of Wirral, L63 4JY

  • The James Cook University Hospital

    Middlesbrough, TS4 3BW

  • Mount Vernon Hospital

    Middlesex, HA6 2RN

  • St Mary's Hospital

    Newport, PO30 5TG

  • City Campus; Academic Unit of Oncology

    Nottingham, NG5 1PB

  • Queen Alexandra Hospital; Portsmouth Haematology & Oncology Centre, Level B

    Portsmouth, PO6 3LY

  • Weston Park Hospital; Cancer Clinical Trials Centre

    Sheffield, S10 2SJ

  • Southampton General Hospital

    Southampton, SO16 6YD

  • City General Hospital

    Stoke-on-Trent, ST4 6QG

  • The Royal Marsden Hospital

    Sutton, SM2 5PT

  • Singleton Hospital; Oncology

    Swansea, SA2 8QA

  • Torbay Hospital; Oncology Department

    Torquay, TQ27AA

  • Royal Cornwall Hospital

    Truro, TR1 3LQ

  • New Cross Hospital; Deansley Centre

    Wolverhampton, WV10 0QP

  • The York Hospital

    York, YO31 8HE

Other trials in United Kingdom

About this study

Official title: 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.

Conditions
Ovarian Cancer
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01863693
Study groupRoleWhat they receive
CohortNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival, defined as time from first administration of first-line therapy to documented disease progression

    Measured: approximately 6 years

  2. Safety: Incidence of adverse events

    Measured: approximately 6 years

Secondary outcomes (5)

  1. Overall survival, defined as time from first administration of first-line therapy to documented death

    Measured: approximately 6 years

  2. Objective response rate, defined as percentage of patients with complete or partial response according to local assessments

    Measured: approximately 6 years

  3. Quality of life: EQ-5D/EORTC questionnaires

    Measured: approximately 6 years

  4. Dosage/schedule/duration of Avastin therapy

    Measured: approximately 6 years

  5. Composition of first-line chemotherapy regimens: drugs/dosage/duration

    Measured: approximately 6 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 May 2013 (estimated)
  2. Study start10 May 2013
  3. Primary completion15 Jun 2018
  4. Study completion15 Jun 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01863693
Sponsor's protocol ID
ML28570
Status last verified
Sep 2018
First submitted
23 May 2013
Last updated
17 Sep 2018
Results posted
No

Publications

  • 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.

    PubMed 31780570

Questions about this trial

What is this clinical trial studying?

An observational study of Ovarian Cancer, run by Hoffmann-La Roche at 30 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival, defined as time from first administration of first-line therapy to documented disease progression (time frame: approximately 6 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01863693, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2018.

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