Intraperitoneal Chemotherapy in Recurrent Ovarian Cancer

July 31, 2024 updated by: Sheng-Mou Hsiao, Far Eastern Memorial Hospital

Intravenous Chemotherapy Versus Intraperitoneal Chemotherapy in Recurrent Ovarian Cancer

This study aims to compare intravenous chemotherapy versus intraperitoneal chemotherapy in patients with recurrent ovarian cancer.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

80

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

woman with recurrent ovarian cancer who was treated with chemotherapy (either intravenous or intraperitoneal)

Description

Inclusion Criteria:

  • women who had recurrent ovarian cancer and was treated with either intravenous or intraperitoneal platinum based chemotherapy

Exclusion Criteria:

  • women who did not complete the designated treatment course (exception to those who had to quit due to progressive disease or death of any cause)

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
intravenous chemotherapy
triweekly chemotherapy with carboplatin AUC=5~6 + liposomal-doxorubicin 30~40mg/m2 or paclitaxel 175mg/m2 0r docetaxel 60~75mg/m2
Drug: Chemotherapy
Intravenous chemotherapy versus intraperitoneal chemotherapy in recurrent ovarian cancer
intraperitoneal chemotherapy

Day 1 IV Paclitaxel 135 mg/m2 + IP Cisplatin 75-100 mg/m2 or IP carboplatin (AUC = 6) Day 8 IP Paclitaxel 60 mg/m2 Every 21 days * 6 cycles

OR

Day 1 IP Carboplatin AUC=5 or IP Cisplatin 50-75mg/m2 Day 2 IV Liposomal doxorubicin 15 mg/m2 + IP Liposomal doxorubicin 15 mg/m2 Every 28 days * 6 cycles
Drug: Chemotherapy
Intravenous chemotherapy versus intraperitoneal chemotherapy in recurrent ovarian cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
RFS
Time Frame: the time interval from the date of surgery or the start of chemotherapy to clinically defined recurrence, disease progression, death from any cause or last follow-up
Recurrence free survival
the time interval from the date of surgery or the start of chemotherapy to clinically defined recurrence, disease progression, death from any cause or last follow-up
OS
Time Frame: the time interval from the date of surgery or the start of chemotherapy to the date of death from any cause or last follow-up
Overall Survival
the time interval from the date of surgery or the start of chemotherapy to the date of death from any cause or 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 (Estimated)

August 15, 2024

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

June 6, 2024

First Submitted That Met QC Criteria

July 31, 2024

First Posted (Actual)

August 2, 2024

Study Record Updates

Last Update Posted (Actual)

August 2, 2024

Last Update Submitted That Met QC Criteria

July 31, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 113130-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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