NCT01863693

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2013

Longer than P75 for all trials

Geographic Reach
1 country

30 active sites

Status
completed

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

Study Start

First participant enrolled

May 10, 2013

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

May 23, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 29, 2013

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2018

Completed
Last Updated

September 17, 2018

Status Verified

September 1, 2018

Enrollment Period

5.1 years

First QC Date

May 23, 2013

Last Update Submit

September 13, 2018

Conditions

Outcome Measures

Primary Outcomes (2)

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

    approximately 6 years

  • Safety: Incidence of adverse events

    approximately 6 years

Secondary Outcomes (5)

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

    approximately 6 years

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

    approximately 6 years

  • Quality of life: EQ-5D/EORTC questionnaires

    approximately 6 years

  • Dosage/schedule/duration of Avastin therapy

    approximately 6 years

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

    approximately 6 years

Study Arms (1)

Cohort

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (30)

Royal United Hospital; Oncology Department

Bath, BA1 3NG, United Kingdom

Location

City Hospital

Birmingham, B18 7QH, United Kingdom

Location

Bradford Royal Infirmary; Oncology Department

Bradford, BD9 6RJ, United Kingdom

Location

Bristol Haematology and Oncology Centre

Bristol, BS2 8ED, United Kingdom

Location

Queen's Hospital; Oncology Department

Burton-on-Trent, DE13 0RB, United Kingdom

Location

Essex County Hospital

Colchester, CO3 3NB, United Kingdom

Location

Eastborne District General Hospital

Eastbourne, BN21 2UD, United Kingdom

Location

Wonford Hospital; Oncology Department

Exeter, EX2 5DW, United Kingdom

Location

Royal Surrey County Hospital

Guildford, GU2 7XX, United Kingdom

Location

Ipswich Hospital

Ipswich, IP4 5PD, United Kingdom

Location

Airedale General Hospital; Research Office Ward 12

Keighley, BD20 6TD, United Kingdom

Location

St James University Hospital

Leeds, LS9 7TF, United Kingdom

Location

Royal Marsden Hospital - London

London, SW3 6JJ, United Kingdom

Location

Maidstone Hospital; Kent Oncology Centre

Maidstone, ME16 0FS, United Kingdom

Location

Christie Hospital Nhs Trust; Medical Oncology

Manchester, M2O 4BX, United Kingdom

Location

The Clatterbridge Cancer Centre NHS Foundation Trust

Metropolitan Borough of Wirral, L63 4JY, United Kingdom

Location

The James Cook University Hospital

Middlesbrough, TS4 3BW, United Kingdom

Location

Mount Vernon Hospital

Middlesex, HA6 2RN, United Kingdom

Location

St Mary's Hospital

Newport, PO30 5TG, United Kingdom

Location

City Campus; Academic Unit of Oncology

Nottingham, NG5 1PB, United Kingdom

Location

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

Portsmouth, PO6 3LY, United Kingdom

Location

Weston Park Hospital; Cancer Clinical Trials Centre

Sheffield, S10 2SJ, United Kingdom

Location

Southampton General Hospital

Southampton, SO16 6YD, United Kingdom

Location

City General Hospital

Stoke-on-Trent, ST4 6QG, United Kingdom

Location

The Royal Marsden Hospital

Sutton, SM2 5PT, United Kingdom

Location

Singleton Hospital; Oncology

Swansea, SA2 8QA, United Kingdom

Location

Torbay Hospital; Oncology Department

Torquay, TQ27AA, United Kingdom

Location

Royal Cornwall Hospital

Truro, TR1 3LQ, United Kingdom

Location

New Cross Hospital; Deansley Centre

Wolverhampton, WV10 0QP, United Kingdom

Location

The York Hospital

York, YO31 8HE, United Kingdom

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2013

First Posted

May 29, 2013

Study Start

May 10, 2013

Primary Completion

June 15, 2018

Study Completion

June 15, 2018

Last Updated

September 17, 2018

Record last verified: 2018-09

Locations