A Study to Evaluate Safety and Effectiveness of Bevacizumab in Combination With Paclitaxel and Cisplatin/Carboplatin or Toptecan in Participants With Advanced Cervical Cancer
2018年3月15日 更新者：Hoffmann-La Roche
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
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.
研究概览
研究类型
观察性的
注册 (实际的)
84
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Buenos Aires、阿根廷、1437
- Hospital General de Agudos J. A. Penna ; Breast Pathology
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Buenos Aires、阿根廷、B1650
- Instituto Ángel H. Roffo - Universidad de Buenos Aires
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Chaco、阿根廷
- Hospital Julio C. Perrando
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Ciudad Autonoma de Buenos Aires、阿根廷、1425
- Hospital General de Agudos Juan Antonio Fernandez
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Jujuy、阿根廷
- Hospital Pablo Soria
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La Rioja、阿根廷、F5300COE
- Centro Oncologico Riojano Integral (CORI)
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Lomas de Zamora、阿根廷
- Hospital Interzonal General De Agudos "Luisa C. de Gandulfo"
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Mar Del Plata、阿根廷、7600
- Hospital Privado de Comunidad; Oncology
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Rosario、阿根廷、S2002KDS
- Hosp Provincial D. Centenarios; Oncology Dept
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Rosario、阿根廷
- CENICLAR
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San Luis、阿根廷
- Policlínico regional de San Luis
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San Miguel de Tucuman、阿根廷、T4000IAK
- Centro Medico San Roque
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
女性
取样方法
非概率样本
研究人群
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.
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
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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.
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This was an observational study.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Percentage of Participants With Gastrointestinal (GI) and Genitourinary (GU) Fistulas and GI Perforations
大体时间：Up to 12 months
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Participants with GI and GU fistulas and GI perforation events will be reported according to Common Terminology Criteria for Adverse Events (CTCAE V4.0).
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Up to 12 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Percentage of Participants who Received Radiotherapy Prior to GI and GU Fistulas and GI Perforation Events
大体时间：Up to 12 months
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Participants who received radiotherapy prior to GI and GU fistulas and GI perforation events will be reported.
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Up to 12 months
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Percentage of Participants who Received Internal, External and Other Radiotherapy
大体时间：Up to 12 months
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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.
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Up to 12 months
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Number of Doses of Prior Radiotherapy
大体时间：Up to 12 months
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Doses of prior radiotherapy will be reported.
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Up to 12 months
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Percentage of Participants With Selected Adverse Events of Special Interest (AESIs)
大体时间：Up to 12 months
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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.
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Up to 12 months
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Overall Response Rate (ORR)
大体时间：Up to 12 months
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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.
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Up to 12 months
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Progression Free Survival (PFS)
大体时间：Up to 12 months
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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.
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Up to 12 months
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Overall Survival (OS)
大体时间：Up to 12 months
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OS is defined as the time from the first dose of treatment to death from any cause.
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Up to 12 months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年4月6日
初级完成 (实际的)
2017年12月20日
研究完成 (实际的)
2017年12月20日
研究注册日期
首次提交
2017年3月2日
首先提交符合 QC 标准的
2017年3月2日
首次发布 (实际的)
2017年3月7日
研究记录更新
最后更新发布 (实际的)
2018年3月16日
上次提交的符合 QC 标准的更新
2018年3月15日
最后验证
2018年3月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
No Intervention的临床试验
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University of Illinois at ChicagoShirley Ryan AbilityLab; Oakland University; Access Living主动，不招人
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University of Wisconsin, MadisonNational Cancer Institute (NCI); Northwestern University主动，不招人
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Otsuka Pharmaceutical Factory, Inc.Celerion完全的