Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Intervention | Other | This was an observational study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants who Received Radiotherapy Prior to GI and GU Fistulas and GI Perforation Events | Participants who received radiotherapy prior to GI and GU fistulas and GI perforation events will be reported. | Up to 12 months |
| Percentage of Participants who Received Internal, External and Other Radiotherapy |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital General de Agudos Juan Antonio Fernandez | Buenos Aires | 1425 | Argentina | |||
| Hospital General de Agudos J. A. Penna ; Breast Pathology |
Not provided
Not provided
Not provided
Not provided
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. |
| Up to 12 months |
| Number of Doses of Prior Radiotherapy | Doses of prior radiotherapy will be reported. | Up to 12 months |
| Percentage of Participants With Selected Adverse Events of Special Interest (AESIs) | 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. | Up to 12 months |
| Overall Response Rate (ORR) | 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. | Up to 12 months |
| Progression Free Survival (PFS) | 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. | Up to 12 months |
| Overall Survival (OS) | OS is defined as the time from the first dose of treatment to death from any cause. | Up to 12 months |
| 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 |
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
Not provided
Not provided