A Study to Evaluate Safety and Effectiveness of Bevacizumab in Combination With Paclitaxel and Cisplatin/Carboplatin or Toptecan in Participants With Advanced Cervical Cancer

NCT ID: NCT03071848

Last Updated: 2018-03-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

84 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-04-06

Study Completion Date

2017-12-20

Brief Summary

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This study will evaluate the safety of bevacizumab (Avastin®) combined with standard chemotherapy in participant with advanced cervical cancer, with special focus on the incidence of gastrointestinal (GI) and genitourinary (GU) fistulas and GI perforations in the common practice setting.

Detailed Description

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Conditions

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Cervical Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Bevacizumab

Participants with advanced cervical cancer (metastatic, recurrent or persistent) who have received treatment with bevacizumab from 01 January 2015 to 01 January 2016 (retrospective and independent from this study) combined with standard chemotherapy (cisplatin/carboplatin or topotecan and paclitaxel) will be observed.

No Intervention

Intervention Type OTHER

This was an observational study.

Interventions

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No Intervention

This was an observational study.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age 18 or older
* Diagnosis of primary stage IVB, recurrent or persistent squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix which is not amenable to curative treatment with surgery and/or radiation therapy
* Retrospective clinical decision made to initiate therapy with bevacizumab (Avastin®) combined with standard chemotherapy (cisplatin or carboplatin or topotecan and paclitaxel) between 01 January 2015 and 01 January 2016
* All participants must have received at least one dose of bevacizumab combined with standard chemotherapy between 01 January 2015 and 01 January 2016 AND have at least 12 months of documented follow up, from treatment start, unless died or lost to follow up within the minimum study entry follow up period
* Availability of documentation of for advanced cervical cancer (including prior treatment as applicable) and follow up in the participant's medical records

Exclusion Criteria

* Participation during the study period in an interventional clinical trial or any other interventional study that may impact advanced cervical cancer outcome
* Participants who have received prior therapy with any anti-VEGF drug, including bevacizumab
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Hospital General de Agudos Juan Antonio Fernandez

Buenos Aires, , Argentina

Site Status

Hospital General de Agudos J. A. Penna ; Breast Pathology

Buenos Aires, , Argentina

Site Status

Instituto Ángel H. Roffo - Universidad de Buenos Aires

Buenos Aires, , Argentina

Site Status

Hospital Julio C. Perrando

Chaco, , Argentina

Site Status

Centro Oncologico Riojano Integral (CORI)

La Rioja, , Argentina

Site Status

Hospital Interzonal General De Agudos "Luisa C. de Gandulfo"

Lomas de Zamora, , Argentina

Site Status

Hospital Privado de Comunidad; Oncology

Mar del Plata, , Argentina

Site Status

Hosp Provincial D. Centenarios; Oncology Dept

Rosario, , Argentina

Site Status

CENICLAR

Rosario, , Argentina

Site Status

Policlínico regional de San Luis

San Luis, , Argentina

Site Status

Centro Medico San Roque

San Miguel de Tucumán, , Argentina

Site Status

Hospital Pablo Soria

San Salvador de Jujuy, , Argentina

Site Status

Countries

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Argentina

Other Identifiers

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ML39360

Identifier Type: -

Identifier Source: org_study_id

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