Cervical CancerNCT03071848
A Study to Evaluate Safety and Effectiveness of Bevacizumab in Combination With Paclitaxel and Cisplatin/Carboplatin or Toptecan in Participants With Advanced Cervical Cancer
An observational study of Cervical Cancer, run by Hoffmann-La Roche at 12 sites in Argentina.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer
- How many people
- 84 participants
- Where
- 12 sitesArgentina
- Study dates
- 6 Apr 2017to 20 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Argentina12 sites
Hospital General de Agudos Juan Antonio Fernandez
Buenos Aires, 1425
Hospital General de Agudos J. A. Penna ; Breast Pathology
Buenos Aires, 1437
Instituto Ángel H. Roffo - Universidad de Buenos Aires
Buenos Aires, B1650
Hospital Julio C. Perrando
Chaco
Centro Oncologico Riojano Integral (CORI)
La Rioja, F5300COE
Hospital Interzonal General De Agudos "Luisa C. de Gandulfo"
Lomas de Zamora
Hospital Privado de Comunidad; Oncology
Mar del Plata, 7600
Hosp Provincial D. Centenarios; Oncology Dept
Rosario, S2002KDS
CENICLAR
Rosario
Policlínico regional de San Luis
San Luis
Centro Medico San Roque
San Miguel de Tucumán, T4000IAK
Hospital Pablo Soria
San Salvador de Jujuy
About this study
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
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.
- Conditions
- Cervical Cancer
- Being tested
- No Intervention
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
This was an observational study.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Up to 12 months
Secondary outcomes (7)
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.
Measured: Up to 12 months
Percentage of Participants who Received Internal, External and Other Radiotherapy
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.
Measured: Up to 12 months
Number of Doses of Prior Radiotherapy
Doses of prior radiotherapy will be reported.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 12 months
Overall Survival (OS)
OS is defined as the time from the first dose of treatment to death from any cause.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2017
- Study start6 Apr 2017
- Primary completion20 Dec 2017
- Study completion20 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03071848
- Sponsor's protocol ID
- ML39360
- Status last verified
- Mar 2018
- First submitted
- 2 Mar 2017
- Last updated
- 16 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03071848
- Acronym / sponsor ID
- ML39360
- Conditions
- Cervical Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 6 Apr 2017 (actual)
- Primary completion
- 20 Dec 2017 (actual)
- Study completion
- 20 Dec 2017 (actual)
- First posted
- 7 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bevacizumab | – | Other: No InterventionParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No InterventionThis was an observational study. | Other | Bevacizumab |
Primary outcome
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).
7 secondary outcomes
Percentage of Participants who Received Radiotherapy Prior to GI and GU Fistulas and GI Perforation Events
Time frame: Up to 12 months
Percentage of Participants who Received Internal, External and Other Radiotherapy
Time frame: Up to 12 months
Number of Doses of Prior Radiotherapy
Time frame: Up to 12 months
Percentage of Participants With Selected Adverse Events of Special Interest (AESIs)
Time frame: Up to 12 months
Overall Response Rate (ORR)
Time frame: Up to 12 months
Progression Free Survival (PFS)
Time frame: Up to 12 months
Overall Survival (OS)
Time frame: Up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Cancer, run by Hoffmann-La Roche at 12 sites in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Gastrointestinal (GI) and Genitourinary (GU) Fistulas and GI Perforations (time frame: Up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2018.