A Study to Evaluate Safety and Effectiveness of Bevacizumab in Combination With Paclitaxel and Cisplatin/Carboplatin or Toptecan in Participants With Advanced Cervical Cancer
|ClinicalTrials.gov Identifier: NCT03071848|
Recruitment Status : Completed
First Posted : March 7, 2017
Last Update Posted : March 16, 2018
|Condition or disease||Intervention/treatment|
|Cervical Cancer||Other: No Intervention|
|Study Type :||Observational|
|Actual Enrollment :||84 participants|
|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|
|Actual Study Start Date :||April 6, 2017|
|Actual Primary Completion Date :||December 20, 2017|
|Actual Study Completion Date :||December 20, 2017|
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.
Other: No Intervention
This was an observational study.
- Percentage of Participants With Gastrointestinal (GI) and Genitourinary (GU) Fistulas and GI Perforations [ Time Frame: Up to 12 months ]Participants with GI and GU fistulas and GI perforation events will be reported according to Common Terminology Criteria for Adverse Events (CTCAE V4.0).
- Percentage of Participants who Received Radiotherapy Prior to GI and GU Fistulas and GI Perforation Events [ Time Frame: Up to 12 months ]Participants who received radiotherapy prior to GI and GU fistulas and GI perforation events will be reported.
- Percentage of Participants who Received Internal, External and Other Radiotherapy [ Time Frame: Up to 12 months ]Participants who received internal, external and other radiotherapy will be reported. External radiotherapy will include "Non Precision Orientated" that includes classic cobalt or "Precision Orientated" that includes Linear accelerator.
- Number of Doses of Prior Radiotherapy [ Time Frame: Up to 12 months ]Doses of prior radiotherapy will be reported.
- Percentage of Participants With Selected Adverse Events of Special Interest (AESIs) [ Time Frame: Up to 12 months ]Adverse events of special interest (AESI) for this study included: hypertension, proteinuria, wound healing complication, bleeding /haemorrrhage (including pulmonary haemorrhage and CNS bleeding), arterial and venous thromboembolic events (ATES; VTES), congestive heart failure (CHF), posterior reversible encephalopathy syndrome (PRES), fistula/abscess (other than genitourinary and gastrointestinal), gastrointestinal perforations and gallbladder perforation.
- Overall Response Rate (ORR) [ Time Frame: Up to 12 months ]Overall response rate was defined as the percentage of participants who had confirmed complete response (CR) or partial response (PR). CR is defined as disappearance of all target and non-target lesions. PR is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. In the case where the only target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required.
- Progression Free Survival (PFS) [ Time Frame: Up to 12 months ]PFS is defined as the time from the first dose of treatment to the first occurrence of progression, or death from any cause as assessed by the investigator. Progressive disease (PD): at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry.
- Overall Survival (OS) [ Time Frame: Up to 12 months ]OS is defined as the time from the first dose of treatment to death from any cause.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03071848
|Hospital General de Agudos J. A. Penna ; Breast Pathology|
|Buenos Aires, Argentina, 1437|
|Instituto Ángel H. Roffo - Universidad de Buenos Aires|
|Buenos Aires, Argentina, B1650|
|Hospital Julio C. Perrando|
|Hospital General de Agudos Juan Antonio Fernandez|
|Ciudad Autonoma de Buenos Aires, Argentina, 1425|
|Hospital Pablo Soria|
|Centro Oncologico Riojano Integral (CORI)|
|La Rioja, Argentina, F5300COE|
|Hospital Interzonal General De Agudos "Luisa C. de Gandulfo"|
|Lomas de Zamora, Argentina|
|Hospital Privado de Comunidad; Oncology|
|Mar Del Plata, Argentina, 7600|
|Hosp Provincial D. Centenarios; Oncology Dept|
|Rosario, Argentina, S2002KDS|
|Policlínico regional de San Luis|
|San Luis, Argentina|
|Centro Medico San Roque|
|San Miguel de Tucuman, Argentina, T4000IAK|
|Study Director:||Clinical Trials||Hoffmann-La Roche|