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 maart 2018 bijgewerkt door: 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.
Studie Overzicht
Studietype
Observationeel
Inschrijving (Werkelijk)
84
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
-
-
-
Buenos Aires, Argentinië, 1437
- Hospital General de Agudos J. A. Penna ; Breast Pathology
-
Buenos Aires, Argentinië, B1650
- Instituto Ángel H. Roffo - Universidad de Buenos Aires
-
Chaco, Argentinië
- Hospital Julio C. Perrando
-
Ciudad Autonoma de Buenos Aires, Argentinië, 1425
- Hospital General de Agudos Juan Antonio Fernandez
-
Jujuy, Argentinië
- Hospital Pablo Soria
-
La Rioja, Argentinië, F5300COE
- Centro Oncologico Riojano Integral (Cori)
-
Lomas de Zamora, Argentinië
- Hospital Interzonal General De Agudos "Luisa C. de Gandulfo"
-
Mar Del Plata, Argentinië, 7600
- Hospital Privado de Comunidad; Oncology
-
Rosario, Argentinië, S2002KDS
- Hosp Provincial D. Centenarios; Oncology Dept
-
Rosario, Argentinië
- CENICLAR
-
San Luis, Argentinië
- Policlínico regional de San Luis
-
San Miguel de Tucuman, Argentinië, T4000IAK
- Centro Medico San Roque
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Vrouw
Bemonsteringsmethode
Niet-waarschijnlijkheidssteekproef
Studie Bevolking
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.
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
|
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.
|
This was an observational study.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Percentage of Participants With Gastrointestinal (GI) and Genitourinary (GU) Fistulas and GI Perforations
Tijdsspanne: 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).
|
Up to 12 months
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Percentage of Participants who Received Radiotherapy Prior to GI and GU Fistulas and GI Perforation Events
Tijdsspanne: Up to 12 months
|
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
Tijdsspanne: 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.
|
Up to 12 months
|
|
Number of Doses of Prior Radiotherapy
Tijdsspanne: Up to 12 months
|
Doses of prior radiotherapy will be reported.
|
Up to 12 months
|
|
Percentage of Participants With Selected Adverse Events of Special Interest (AESIs)
Tijdsspanne: 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.
|
Up to 12 months
|
|
Overall Response Rate (ORR)
Tijdsspanne: 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.
|
Up to 12 months
|
|
Progression Free Survival (PFS)
Tijdsspanne: 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.
|
Up to 12 months
|
|
Overall Survival (OS)
Tijdsspanne: Up to 12 months
|
OS is defined as the time from the first dose of treatment to death from any cause.
|
Up to 12 months
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
6 april 2017
Primaire voltooiing (Werkelijk)
20 december 2017
Studie voltooiing (Werkelijk)
20 december 2017
Studieregistratiedata
Eerst ingediend
2 maart 2017
Eerst ingediend dat voldeed aan de QC-criteria
2 maart 2017
Eerst geplaatst (Werkelijk)
7 maart 2017
Updates van studierecords
Laatste update geplaatst (Werkelijk)
16 maart 2018
Laatste update ingediend die voldeed aan QC-criteria
15 maart 2018
Laatst geverifieerd
1 maart 2018
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- ML39360
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .