Intraperitoneal Chemotherapy in Recurrent Ovarian Cancer

NCT06535334 | Not Yet Recruiting

• 1 other identifier: 113130-E
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Intravenous Chemotherapy Versus Intraperitoneal Chemotherapy in Recurrent Ovarian Cancer

Outcome Measures

Primary Outcomes (2)

• RFS

  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

  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

Study Arms (2)

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

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

Interventions

Chemotherapy DRUG

Intravenous chemotherapy versus intraperitoneal chemotherapy in recurrent ovarian cancer

intraperitoneal chemotherapy; intravenous chemotherapy

Eligibility Criteria

• Age: 20 Years+
• Gender Eligibility Details: women with ovarian cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Far Eastern Memorial Hospital: lead

Study Sites (1)

Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital

Banqiao District, New Taipei, 22050, Taiwan

Location

MeSH Terms

Interventions

Drug Therapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 6, 2024
• First Posted: August 2, 2024
• Study Start: August 15, 2024
• Primary Completion: June 1, 2025
• Study Completion: May 1, 2026
• Last Updated: August 2, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)