Intraperitoneal Chemotherapy Versus Triweekly Chemotherapy

July 6, 2023 updated by: Sheng-Mou Hsiao, Far Eastern Memorial Hospital

Triweekly Chemotherapy With Bevacizumab Versus Intraperitoneal Chemotherapy as Frontline Therapy in Advanced Ovarian Cancer

The combination of paclitaxel and carboplatin is the standard first-line chemotherapy for ovarian cancer as recommended by the NCCN Guidelines for Epithelial Ovarian Cancer, and is conventionally given via intravenous route every three weeks. The addition of target therapy (bevacizumab) has shown to improve progression free survival but not overall survival. Several trials have also demonstrated a clinically significant survival advantage associated with intraperitoneal chemotherapy compared to intravenous chemotherapy, and the best outcomes are consistently seen for patients who have no residual disease. This study aims to compare triweekly chemotherapy with bevacizumab versus intraperitoneal chemotherapy in patients with advanced stage ovarian cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

59

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
    • New Taipei
      • Banqiao, New Taipei, Taiwan, 22050
        • Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

women aged 20 and above with FIGO stage II-IV advanced ovarian, fallopian tube or primary peritoneal cancer

Description

Inclusion Criteria:

  • women aged 20 and above with FIGO stage II-IV advanced ovarian, fallopian tube or primary peritoneal cancer who received debulking surgery, followed by either triweekly intravenous chemotherapy with bevacizumab or intraperitoneal chemotherapy; women who received neoadjuvant chemotherapy followed by interval debulking surgery were also eligible for participation. Intraperitoneal chemotherapy was defined as having one or more cycles of an intraperitoneal regimen administered.

Exclusion Criteria:

  • women who quit half-way or received chemotherapy at other site

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Intraperitoneal group
The intraperitoneal regimen was given as 135 mg/m2 intravenous paclitaxel over a 3 or 24 hours period on day 1, followed by 75-100 mg/m2 intraperitoneal cisplatin on day 2 and 60 mg/m2 intraperitoneal paclitaxel on day 8. For women with significantly impaired renal function (i.e., estimated glomerular filtration rate<50 mL/min/1.73 m2), carboplatin (area under the curve [AUC]=6) was used instead of cisplatin.
Drug: Chemotherapy
Triweekly chemotherapy with bevacizumab versus intraperitoneal chemotherapy without bevacizumab
Triweekly group
The triweekly intravenous chemotherapy regimen was given as 175 mg/m2 paclitaxel and carboplatin at a dose calculated to produce an AUC of 6 mg/mL/min on day 1. Bevacizumab was given at a dose of 7.5mg/kg intravenously on day 2 since cycle 2. The treatments were repeated every 3 weeks for 6 cycles. Those women without achievement of complete response after 6 cycles of chemotherapy might be treated with an additional 1-2 cycles of chemotherapy. Bevacizumab was continued for 12 additional cycles or until disease progression, death, unacceptable toxic effects, or patient voluntary withdrawal [5].
Drug: Chemotherapy
Triweekly chemotherapy with bevacizumab versus intraperitoneal chemotherapy without bevacizumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression free survival
Time Frame: the time interval from the date of surgery or neoadjuvant chemotherapy to clinically defined recurrence, disease progression, or the last follow-up
the time interval from the date of surgery or neoadjuvant chemotherapy to clinically defined recurrence, disease progression, or the last follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: the time interval from the date of surgery or neoadjuvant chemotherapy to the date of death from any cause or the last follow-up
the time interval from the date of surgery or neoadjuvant chemotherapy to the date of death from any cause or the last follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Far Eastern Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 6, 2022

Primary Completion (Actual)

May 1, 2023

Study Completion (Actual)

May 1, 2023

Study Registration Dates

First Submitted

June 6, 2022

First Submitted That Met QC Criteria

June 6, 2022

First Posted (Actual)

June 8, 2022

Study Record Updates

Last Update Posted (Actual)

July 10, 2023

Last Update Submitted That Met QC Criteria

July 6, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 111113-E

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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