- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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
15. mars 2018 oppdatert av: 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.
Studieoversikt
Studietype
Observasjonsmessig
Registrering (Faktiske)
84
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Buenos Aires, Argentina, 1437
- Hospital General de Agudos J. A. Penna ; Breast Pathology
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Buenos Aires, Argentina, B1650
- Instituto Ángel H. Roffo - Universidad de Buenos Aires
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Chaco, Argentina
- Hospital Julio C. Perrando
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Ciudad Autonoma de Buenos Aires, Argentina, 1425
- Hospital General de Agudos Juan Antonio Fernandez
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Jujuy, Argentina
- Hospital Pablo Soria
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La Rioja, Argentina, F5300COE
- Centro Oncologico Riojano Integral (CORI)
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Lomas de Zamora, Argentina
- Hospital Interzonal General De Agudos "Luisa C. de Gandulfo"
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Mar Del Plata, Argentina, 7600
- Hospital Privado de Comunidad; Oncology
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Rosario, Argentina, S2002KDS
- Hosp Provincial D. Centenarios; Oncology Dept
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Rosario, Argentina
- CENICLAR
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San Luis, Argentina
- Policlínico regional de San Luis
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San Miguel de Tucuman, Argentina, T4000IAK
- Centro Medico San Roque
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Hunn
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
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.
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
---|---|
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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Percentage of Participants With Gastrointestinal (GI) and Genitourinary (GU) Fistulas and GI Perforations
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Percentage of Participants who Received Radiotherapy Prior to GI and GU Fistulas and GI Perforation Events
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
6. april 2017
Primær fullføring (Faktiske)
20. desember 2017
Studiet fullført (Faktiske)
20. desember 2017
Datoer for studieregistrering
Først innsendt
2. mars 2017
Først innsendt som oppfylte QC-kriteriene
2. mars 2017
Først lagt ut (Faktiske)
7. mars 2017
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
16. mars 2018
Siste oppdatering sendt inn som oppfylte QC-kriteriene
15. mars 2018
Sist bekreftet
1. mars 2018
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- ML39360
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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