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Completed

NCT Number: NCT01863693

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

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.

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Key information

Conditions

Ovarian Cancer Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Royal United Hospital; Oncology Department, Bath, United Kingdom

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: approximately 6 years

  2. Safety: Incidence of adverse events

    Time frame: approximately 6 years

Secondary outcomes

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

    Time frame: approximately 6 years

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

    Time frame: approximately 6 years

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

    Time frame: approximately 6 years

  4. Dosage/schedule/duration of Avastin therapy

    Time frame: approximately 6 years

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

    Time frame: approximately 6 years

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
May 29, 2013
Registry last updated
Sep 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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