Efficacy of HIPEC in the Treatment of Advanced-Stage Epithelial Ovarian Cancer After Cytoreductive Surgery (EHTASEOCCS)

November 4, 2019 updated by: Affiliated Cancer Hospital & Institute of Guangzhou Medical University

A Phase III Multicenter Prospective Randomized Controlled Clinical Trial of Hyperthermic Intraperitoneal Chemotherapy in the Treatment of Advanced-Stage Epithelial Ovarian Cancer After Cytoreductive Surgery

This project is a multi-center, prospective, randomized controlled clinical observation the safety and efficacy of hyperthermic intraperitoneal chemotherapy in the treatment of advanced-stage epithelial ovarian cancer after cytoreductive surgery. Median recurrence-free survival is the primary end points of this project.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The current standard treatment for epithelial ovarian cancer, tubal cancer, and primary peritoneal cancer is maximal cytoreductive surgery followed by intravenous chemotherapy with or without intraperitoneal chemotherapy (IP). Recently, the organizations of SGO and ASCO recommended that women with Fagotti score by laparoscopic exploration < 6 would benefit from primary cytoreductive surgery followed by postoperative chemotherapy, and are likely to attain optimal cytoreduction (residual lesion ≤ 1 cm).

Hyperthermia promotes chemotherapy to penetrate deeper into the cancer tissue. Therefore, hyperthermic intraperitoneal chemotherapy (HIPEC) as newly postoperative chemotherapy after primary cytoreductive surgery in the treatment of ovarian cancer could lead to higher response rate and better survival outcomes.

Study Type

Interventional

Enrollment (Anticipated)

310

Phase

  • Phase 3

Contacts and Locations

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

Study Contact

  • Name: Xian-Zi Yang, M.D
  • Phone Number: 0086-188-9853-4167
  • Email: 7097359@qq.com

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Beijing Cancer Hospital
        • Contact:
          • Yunong Gao, MD
          • Phone Number: 010-88196216
        • Sub-Investigator:
          • Qian Li, MD
      • Chongqing, China
        • Recruiting
        • Chongqing Cancer Hospital
        • Contact:
        • Sub-Investigator:
          • Xingtao Long, MD
      • Chongqing, China
        • Recruiting
        • The First Affiliated Hospital of Chongqing Medical University
        • Contact:
        • Sub-Investigator:
          • Lin Xiao, MD
      • Wuhan, China
      • Zhengzhou, China
        • Recruiting
        • Henan cancer hospital
        • Contact:
          • Li Wang, MD
    • Guangdong
      • Guangzhou, Guangdong, China, 510095
        • Recruiting
        • Affiliated Tumor Hospital of Guangzhou Medical University
        • Contact:
      • Guanzhou, Guangdong, China, 510235
        • Recruiting
        • Sun Yat-sen Memorial Hospital,Sun Yat-sen University
        • Contact:
        • Sub-Investigator:
          • Jing Li, MD

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

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Disease status primary epithelial ovarian cancer, tubal cancer, and primary peritoneal cancer (Stage III )
  • Fagotti score by laparoscopic exploration < 6
  • Residual tumor < 1cm after completion of cytoreductive surgery
  • 18 < Age < 70 year old
  • Expected survival > 3 months
  • Performance status: ECOG 0-1
  • Adequate bone marrow function Hb ≥8 g/dl (After correction in case of iron deficient anemia) WBC ≥ 3,000/mm3, Platelet ≥ 100,000/mm3
  • Adequate renal function Creatinine ≤ 1.5 mg/dl, and adequate hepatic function Bilirubin ≤ 1.5 mg/dl and AST and ALT ≤ 80 IU/L
  • Voluntary participation after getting written informed consent.

Exclusion Criteria:

  • Fagotti score by laparoscopic exploration >= 6
  • Suboptimal debulking (residual tumor > 1cm)
  • Extensive adhesion in peritoneal cavity
  • Previous History of other malignancies (except excision of skin cancer, thyroid cancer)
  • Poorly controlled disease e.g. atrial fibrillation, stenocardia, cardiac insufficiency, persistent hypertension despite medicinal treatment, ejection fraction<50%
  • Receiving other chemotherapy, radiotherapy or immunotherapy
  • Patients who are unsuitable candidates by doctor's decision
  • Without given written informed consent

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

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Experimental group
  1. Cytoreductive surgery
  2. Hyperthermic Intraperitoneal Chemotherapy (HIPEC) with Docetaxel 75 mg/m^2 and cisplatin 75 mg/m^2 intraperitoneally in succession
  3. 6 cycles of adjuvant chemotherapy: paclitaxel 175 mg/m^2 IV>3 hour(Docetaxel 75 mg/m^2, if paclitaxel is not available.)+ carboplatin AUC = 5-6 IV>1 hour, every 3 weeks.
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.

Other Names:
  • ACT
Procedure: Hyperthermic Intraperitoneal Chemotherapy
HIPEC is performed as postoperative chemotherapy after cytoreductive surgery for advanced-stage epithelial ovarian cancer. The first HIPEC is conducted within 48h after cytoreductive surgery: Paclitaxel 175 mg/m^2, 43°C, 90min. The second HIPEC is performed after 48 hours of the first HIPEC. The HIPEC regimens are Docetaxel 75 mg/m^2 and cisplatin 75 mg/m^2, respectively, 43°C, 90min.
Other Names:
  • HIPEC
Procedure: cytoreductive surgery
Cytoreductive surgery (CRS) is performed when Faggoti value is less than 6 via laparoscopic exploration.
Other Names:
  • CRS
ACTIVE_COMPARATOR: Control group
  1. Cytoreductive surgery
  2. 6 cycles of adjuvant chemotherapy: paclitaxel 175 mg/m^2 IV>3 hour(Docetaxel 75 mg/m^2, if paclitaxel is not available)+ carboplatin AUC = 5-6 IV>1 hour, every 3 weeks.
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.

Other Names:
  • ACT
Procedure: cytoreductive surgery
Cytoreductive surgery (CRS) is performed when Faggoti value is less than 6 via laparoscopic exploration.
Other Names:
  • CRS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Median recurrence-free survival
Time Frame: 3 years
assess median recurrence-free survival during 3 years in both study arms
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life for ovarian cancer
Time Frame: 3 years
Evaluated according to European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Ovarian Cancer Module (QLQ-OV28)
3 years
Median overall survival
Time Frame: 3 years
assess median overall survival during 3 years in both study arms
3 years
Median progression-free survival
Time Frame: 3 years
assess median progression-free survival during 3 years in both study arms
3 years
Risk factors for morbidity and mortality
Time Frame: 30 days; 3 years
The early complication and mortality are defined as the event observed within 30 days after intervention, while the time frame for late complication is the period beyond 30 days after intervention to the end of 3 years. Complications are ranked from grade 0-5 according to CTCAE V4.0
30 days; 3 years

Collaborators and Investigators

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

Sponsor

Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Collaborators

Chongqing University Cancer Hospital
Xiangya Hospital of Central South University
Wuhan University
Peking University People's Hospital
Peking Union Medical College Hospital
Chinese PLA General Hospital
The Second Hospital of Hebei Medical University
First Affiliated Hospital, Sun Yat-Sen University
RenJi Hospital
The Third Affiliated Hospital of Guangzhou Medical University
Henan Cancer Hospital
Peking University Cancer Hospital & Institute
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Tianjin Medical University Cancer Institute and Hospital
Shandong Cancer Hospital and Institute
The Third Xiangya Hospital of Central South University
Henan Provincial People's Hospital
Third Affiliated Hospital, Sun Yat-Sen University
Wuhan Union Hospital, China
Hebei Medical University Fourth Hospital
Affiliated Cancer Hospital of Shantou University Medical College
Xinqiao Hospital of Chongqing
Obstetrics & Gynecology Hospital of Fudan University
Southern Medical University, China
First Affiliated Hospital of Chongqing Medical University
West China Second University Hospital
Beijing Obstetrics and Gynecology Hospital
Cancer Hospital of Guizhou Province
Fourth Affiliated Hospital of Guangxi Medical University

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)

October 15, 2019

Primary Completion (ANTICIPATED)

July 1, 2021

Study Completion (ANTICIPATED)

July 1, 2023

Study Registration Dates

First Submitted

December 4, 2017

First Submitted That Met QC Criteria

December 8, 2017

First Posted (ACTUAL)

December 14, 2017

Study Record Updates

Last Update Posted (ACTUAL)

November 6, 2019

Last Update Submitted That Met QC Criteria

November 4, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HIPEC-03

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.

Clinical Trials on Fallopian Tube Cancer

Clinical Trials on adjuvant chemotherapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Armenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe