Efficacy of HIPEC as NACT and Postoperative Chemotherapy in the Treatment of Advanced-Stage Epithelial Ovarian Cancer

Summary

This project is a multi-center, prospective, randomized controlled clinical observation the safety and efficacy of hyperthermic intraperitoneal chemotherapy as neoadjuvant chemotherapy(NACT) and postoperative chemotherapy after interval debulking surgery (IDS) for advanced-stage epithelial ovarian cancer . PR/SD rate, percentage of optimal debulking surgery and 3-year disease-free survival is the primary end points of this project.

Conditions

• Epithelial Ovarian Cancer
• Fallopian Tube Cancer
• Primary Peritoneal Carcinoma

Interventions

PROCEDURE

Hyperthermic Intraperitoneal Chemotherapy

HIPEC is performed as neoadjuvant chemotherapy(NACT) and postoperative chemotherapy after interval debulking surgery (IDS) for advanced-stage epithelial ovarian cancer. The first HIPEC is conducted within 24h after laparoscopic exploration or Interval debulking surgery: Paclitaxel 175 mg/m\^2, 43°C, 90min. The second HIPEC is performed after 48 hours of the first HIPEC. The second HIPEC regimens are cisplatin 75 mg/m\^2, 43°C, 90min.

PROCEDURE

Interval debulking surgery

Cytoreductive surgery (CRS) is performed after neoadjuvant chemotherapy.

DRUG

neoadjuvant chemotherapy

Systemic chemotherapy regimens after HIPEC treatment are paclitaxel 175 mg/m\^2 IV\>3 hour+ carboplatin AUC = 5-6 IV\>1 hour, every 3 weeks for 2 cycles in experimental group. Systemic chemotherapy regimens after laparoscopic exploration are paclitaxel 175 mg/m\^2 IV\>3 hour+ carboplatin AUC = 5-6 IV\>1 hour, every 3 weeks for 3 cycles in control group.

DRUG

adjuvant chemotherapy

Systemic chemotherapy regimens after HIPEC treatment are paclitaxel 175 mg/m\^2 IV\>3 hour+ carboplatin AUC = 5-6 IV\>1 hour, every 3 weeks for 2 cycles in experimental group. Systemic chemotherapy regimens after IDS are paclitaxel 175 mg/m\^2 IV\>3 hour+ carboplatin AUC = 5-6 IV\>1 hour, every 3 weeks for 3 cycles in control group.

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

  collaborator OTHER

• Third Affiliated Hospital, Sun Yat-Sen University

  collaborator OTHER

• Henan Provincial People's Hospital

  collaborator OTHER

• Xiangya Hospital of Central South University

  collaborator OTHER

• The Third Xiangya Hospital of Central South University

  collaborator OTHER

• Peking University Cancer Hospital & Institute

  collaborator OTHER

• Peking University People's Hospital

  collaborator OTHER

• Cancer Hospital of Guizhou Province

  collaborator OTHER

• Chinese PLA General Hospital

  collaborator OTHER

• Hebei Medical University Fourth Hospital

  collaborator OTHER

• The Second Hospital of Hebei Medical University

  collaborator OTHER

• West China Second University Hospital

  collaborator OTHER

• Peking Union Medical College Hospital

  collaborator OTHER

• First Affiliated Hospital, Sun Yat-Sen University

  collaborator OTHER

• Henan Cancer Hospital

  collaborator OTHER_GOV

• Tianjin Medical University Cancer Institute and Hospital

  collaborator OTHER

• The Third Affiliated Hospital of Guangzhou Medical University

  collaborator OTHER

• Wuhan University

  collaborator OTHER

• RenJi Hospital

  collaborator OTHER

• Obstetrics & Gynecology Hospital of Fudan University

  collaborator OTHER

• Southern Medical University, China

  collaborator OTHER

• Fourth Affiliated Hospital of Guangxi Medical University

  collaborator OTHER

• Shandong Cancer Hospital and Institute

  collaborator OTHER

• Beijing Obstetrics and Gynecology Hospital

  collaborator OTHER

• Chongqing Cancer Institute

  collaborator UNKNOWN

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  collaborator OTHER

• Xinqiao Hospital of Chongqing

  collaborator OTHER

• Shu-Zhong Cui

  lead OTHER

Principal Investigators

• Shuzhong Cui, M.D · Affiliated Cancer Hospital & Institute of Guangzhou Medical University

• Zhongqiu Lin, M.D · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-03-01

Primary Completion

2021-07-01

Completion

2022-07-01

Countries

• China

Study Locations