A Study to Evaluate Safety and Effectiveness of Bevacizumab in Combination With Paclitaxel and Cisplatin/Carboplatin or Toptecan in Participants With Advanced Cervical Cancer
Retrospective Multicenter Observational Study to Evaluate Safety and Effectiveness of Bevacizumab (Avastin®) in Combination With Paclitaxel and Cisplatin/Carboplatin or Toptecan in Patients With Advanced Cervical Cancer
1 other identifier
observational
84
1 country
12
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2017
Shorter than P25 for all trials
12 active sites
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
First Submitted
Initial submission to the registry
March 2, 2017
CompletedFirst Posted
Study publicly available on registry
March 7, 2017
CompletedStudy Start
First participant enrolled
April 6, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 20, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 20, 2017
CompletedMarch 16, 2018
March 1, 2018
9 months
March 2, 2017
March 15, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Gastrointestinal (GI) and Genitourinary (GU) Fistulas and GI Perforations
Participants with GI and GU fistulas and GI perforation events will be reported according to Common Terminology Criteria for Adverse Events (CTCAE V4.0).
Up to 12 months
Secondary Outcomes (7)
Percentage of Participants who Received Radiotherapy Prior to GI and GU Fistulas and GI Perforation Events
Up to 12 months
Percentage of Participants who Received Internal, External and Other Radiotherapy
Up to 12 months
Number of Doses of Prior Radiotherapy
Up to 12 months
Percentage of Participants With Selected Adverse Events of Special Interest (AESIs)
Up to 12 months
Overall Response Rate (ORR)
Up to 12 months
- +2 more secondary outcomes
Study Arms (1)
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.
Interventions
Eligibility Criteria
Participants with advanced cervical cancer (metastatic, recurrent or persistent) who have received treatment with bevacizumab from 01 January 2015 to 01 January 2016 will be observed.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Hospital General de Agudos Juan Antonio Fernandez
Buenos Aires, 1425, Argentina
Hospital General de Agudos J. A. Penna ; Breast Pathology
Buenos Aires, 1437, Argentina
Instituto Ángel H. Roffo - Universidad de Buenos Aires
Buenos Aires, B1650, Argentina
Hospital Julio C. Perrando
Chaco, Argentina
Centro Oncologico Riojano Integral (CORI)
La Rioja, F5300COE, Argentina
Hospital Interzonal General De Agudos "Luisa C. de Gandulfo"
Lomas de Zamora, Argentina
Hospital Privado de Comunidad; Oncology
Mar del Plata, 7600, Argentina
Hosp Provincial D. Centenarios; Oncology Dept
Rosario, S2002KDS, Argentina
CENICLAR
Rosario, Argentina
Policlínico regional de San Luis
San Luis, Argentina
Centro Medico San Roque
San Miguel de Tucumán, T4000IAK, Argentina
Hospital Pablo Soria
San Salvador de Jujuy, Argentina
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 2, 2017
First Posted
March 7, 2017
Study Start
April 6, 2017
Primary Completion
December 20, 2017
Study Completion
December 20, 2017
Last Updated
March 16, 2018
Record last verified: 2018-03