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Evaluation of Optimal Treatment Duration of Bevacizumab Combination With Standard Chemotherapy in Patients With Ovarian Cancer

NCT01462890 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 927

Last updated 2022-07-20

No results posted yet for this study

Summary

The purpose of this study is to determine whether the early and continuous addition of bevacizumab for up to 30 months to the standard chemotherapy is more effective than the early and continuous addition of bevacizumab for up to 15 months.

Conditions

  • Genital Diseases, Female
  • Ovarian Diseases
  • Ovarian Neoplasms
  • Fallopian Tube Neoplasms
  • Peritoneal Neoplasms

Interventions

BIOLOGICAL

Bevacizumab

15 mg/kg, iv on day 1 every 3 weeks up to and including cycle 22 vs cycle 44

DRUG

Paclitaxel

175 mg/m², iv on day 1 every 3 weeks for 6 cycles

DRUG

Carboplatin

AUC 5, iv on day 1 every 3 weeks for 6 cycles

OTHER

specialized pathology review (Germany only)

before randomization

Sponsors & Collaborators

  • ARCAGY/ GINECO GROUP

    collaborator OTHER

  • Nordic Society of Gynaecological Oncology - Clinical Trials Unit

    collaborator OTHER

  • AGO Study Group

    lead OTHER

Principal Investigators

  • Jacobus Pfisterer, MD PhD · AGO Study Group

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2020-12-31
Completion
2021-12-31

Countries

  • Denmark
  • Finland
  • France
  • Germany
  • Norway
  • Sweden

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01462890 on ClinicalTrials.gov