Clinical trial NCT03071848: A Study to Evaluate Safety and Effectiveness of Bevacizumab in Combination With Paclitaxel and Cisplatin/Carboplatin or Toptecan in Participants With Advanced Cervical Cancer
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2017-03-07
Enrollment: 84
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants With Gastrointestinal (GI) and Genitourinary (GU) Fistulas and GI Perforations
timeFrame: Up to 12 months
Secondary outcomes:
measure: Percentage of Participants who Received Radiotherapy Prior to GI and GU Fistulas and GI Perforation Events
timeFrame: Up to 12 months
measure: Percentage of Participants who Received Internal, External and Other Radiotherapy
timeFrame: Up to 12 months
measure: Number of Doses of Prior Radiotherapy
timeFrame: Up to 12 months
measure: Percentage of Participants With Selected Adverse Events of Special Interest (AESIs)
timeFrame: Up to 12 months
measure: Overall Response Rate (ORR)
timeFrame: Up to 12 months
measure: Progression Free Survival (PFS)
timeFrame: Up to 12 months
measure: Overall Survival (OS)
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Hospital General de Agudos J. A. Penna ; Breast Pathology
city: Buenos Aires
country: Argentina
facility: Instituto Ángel H. Roffo - Universidad de Buenos Aires
city: Chaco
country: Argentina
facility: Hospital Julio C. Perrando
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Hospital General de Agudos Juan Antonio Fernandez
city: Jujuy
country: Argentina
facility: Hospital Pablo Soria
city: La Rioja
country: Argentina
facility: Centro Oncologico Riojano Integral (CORI)
city: Lomas de Zamora
country: Argentina
facility: Hospital Interzonal General De Agudos "Luisa C. de Gandulfo"
city: Mar Del Plata
country: Argentina
facility: Hospital Privado de Comunidad; Oncology
city: Rosario
country: Argentina
facility: Hosp Provincial D. Centenarios; Oncology Dept
city: Rosario
country: Argentina
facility: CENICLAR
city: San Luis
country: Argentina
facility: Policlínico regional de San Luis
city: San Miguel de Tucuman
country: Argentina
facility: Centro Medico San Roque
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: