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Ovarian CancerREBECANCT03367182

Real-World Effectiveness of Bevacizumab Based on AURELIA in Platinum-resistant Recurrent Ovarian Cancer

An observational study of Ovarian Cancer, run by Yonsei University at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will evaluate the efficacy and safety profile, response rate, progression free survival, overall survival of bevacizumab (Avastin) added to chemotherapy in patients with epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal carcinoma with disease progression within 6 months of platinum… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
Weekly paclitaxel, Topotecan and Pegylated liposomal doxorubicin
Type of treatment
Injection or infusion
How many people
50 participants
Where
1 siteSouth Korea
Study dates
1 Sep 2017to 31 Jan 2018
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: Patients with epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal carcinoma with desease progression within 6 months of platinum treatment.

Who may be able to join

  • Patients who have histologically or cytologically confirmed recurrent epithelial ovarian cancer, fallopian tube cancer, or peritoneal cancer.
  • Patients who have platinum-resistant disease (defined as having relapsed within 6 months of her last platinum-containing regimen)
  • Patients who have underwent chemotherapy of either weekly paclitaxel + bevacizumab, topotecan + bevacizumab, pegylated liposomal doxorubicin + bevacizumab in 2nd line or 3rd line chemotherapy.

Who cannot join

  • Patients with previous treatment with bevacizumab.
  • Patients who received bevacizumab combination therapy in 4th line or more chemotherapy.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Severance hospital

    Seoul, 03722

Other trials in South Korea

About this study

This study will evaluate the efficacy and safety profile, response rate, progression free survival, overall survival of bevacizumab (Avastin) added to chemotherapy in patients with epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal carcinoma with disease progression within 6 months of platinum treatment.

Conditions
Ovarian Cancer
Being tested
Weekly paclitaxel, Topotecan, Pegylated liposomal doxorubicin, Bevacizumab
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Weekly paclitaxelDrug

    Drug: paclitaxel 80mg/m2 iv on days 1, 8, 15 and 22 of each 4-week cycle

  • TopotecanDrug

    Drug: topotecan 4mg/m2 iv on days 1, 8 and 15 of each 4-week cycle, or 1.25 mg/kg on days 1-5 of each 3-week cycle

  • Pegylated liposomal doxorubicinDrug

    Drug: liposomal doxorubicin 40mg/m2 iv every 4 weeks

  • BevacizumabDrug

    Drug: bevacizumab [Avastin] 10m/kg iv every 2 weeks or 15mg/kg iv every 3 weeks

Study groups in NCT03367182
Study groupRoleWhat they receive
Weekly paclitaxel + bevacizumabNot described
Receives: Drug: Weekly paclitaxel; Drug: Bevacizumab
Topotecan + bevacizumabNot described
Receives: Drug: Topotecan; Drug: Bevacizumab
Pegylated liposomal doxorubicin + bevacizumabNot described
Receives: Drug: Pegylated liposomal doxorubicin; Drug: Bevacizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression free survival (PFS)

    PFS was defined as the time from the date of randomization to the first documented disease progression or death, whichever occurred first. Progression was based on tumor assessment made by the investigators according to the RECIST criteria

    Measured: 36 months

  2. Incidence of Treatment-Emergent Adverse Events

    Safety and tolerability will be assessed in deaths, laboratory data, and vital signs. Number of participants with treatment-related adverse events as assessed by CTCAE version 4.0.

    Measured: 36 months

Secondary outcomes (2)

  1. Response rate

    Best Overall Confirmed Objective Response of Complete Response (CR) or Partial Response (PR) by Modified RECIST until progression reported. Objective Response was determined by the investigator using modified RECIST criteria, Version 1.0. An objective response was a complete or partial overall confirmed response as determined by investigators. CR defined as complete disappearance of all target and non-target lesions and no new lesions. PR defined as greater than or equal to (≥) 30 percent (%) decrease in the sum of appropriate diameters of all target measurable lesions, no progress in the non-measurable disease, and no new lesions.

    Measured: 36 months

  2. overall survival (OS)

    Duration of overall survival was defined as the time from randomization to death of any cause. The OS data for participants for whom no death was captured in the clinical database were censored at the last time they were known to be alive.

    Measured: 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Dec 2017
  2. Study start1 Sep 2017
  3. Primary completion31 Jan 2018
  4. Study completion31 Jan 2018

Resources

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
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03367182
Sponsor's protocol ID
4-2017-0748
Acronym
REBECA
Status last verified
Jan 2019
First submitted
29 Nov 2017
Last updated
11 Jan 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lee JY, Park JY, Park SY, Lee JW, Kim JW, Kim YB, Jeong DH, Lee KB, Kim TH, Lee IH, Choi MC, Kim KH, Kim YM, Lee YJ, Kang S; KGOG Investigators; Pujade-Lauraine E. Real-world effectiveness of bevacizumab based on AURELIA in platinum-resistant recurrent ovarian cancer (REBECA): A Korean Gynecologic Oncology Group study (KGOG 3041). Gynecol Oncol. 2019 Jan;152(1):61-67. doi: 10.1016/j.ygyno.2018.10.031. Epub 2018 Nov 6.

    PubMed 30409490

Questions about this trial

What is this clinical trial studying?

An observational study of Ovarian Cancer, run by Yonsei University at 1 site in South Korea.

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 3 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 11 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. 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?

Progression free survival (PFS) (time frame: 36 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03367182, which also lists 1 linked publication.

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 11 Jan 2019.

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