Intraperitoneal Chemotherapy Versus Triweekly Chemotherapy

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.

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Key information

Conditions

Intraperitoneal Chemotherapy, Bevacizumab, Ovarian Cancer Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

20 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital

Banqiao District, New Taipei, 22050, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chemotherapy

Drug

Triweekly chemotherapy with bevacizumab versus intraperitoneal chemotherapy without bevacizumab

Primary outcomes

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

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Far Eastern Memorial Hospital

Other

Registry information

Official study title

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

Important dates

Study start: 2022
Primary completion: 2023
Study completion: 2023
First posted: Jun 8, 2022
Registry last updated: Jul 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed