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

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ClinicalTrials.gov Identifier: NCT03373058

Recruitment Status : Recruiting

First Posted : December 14, 2017

Last Update Posted : November 6, 2019

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View this study on Beta.ClinicalTrials.gov

Sponsor:

Collaborators:

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

Third Affiliated Hospital, Sun Yat-Sen University

Henan Provincial People's Hospital

Xiangya Hospital of Central South University

The Third Xiangya Hospital of Central South University

Peking University Cancer Hospital & Institute

Peking University People's Hospital

Cancer Hospital of Guizhou Province

Chinese PLA General Hospital

Hebei Medical University Fourth Hospital

The Second Hospital of Hebei Medical University

West China Second University Hospital

Peking Union Medical College Hospital

First Affiliated Hospital, Sun Yat-Sen University

Henan Cancer Hospital

Tianjin Medical University Cancer Institute and Hospital

The Third Affiliated Hospital of Guangzhou Medical University

Wuhan University

RenJi Hospital

Obstetrics & Gynecology Hospital of Fudan University

Southern Medical University, China

Fourth Affiliated Hospital of Guangxi Medical University

Shandong Cancer Hospital and Institute

Beijing Obstetrics and Gynecology Hospital

Chongqing University Cancer Hospital

Xinqiao Hospital of Chongqing

Wuhan Union Hospital, China

First Affiliated Hospital of Chongqing Medical University

Affiliated Cancer Hospital of Shantou University Medical College

Information provided by (Responsible Party):

Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Epithelial Ovarian Cancer Fallopian Tube Cancer Primary Peritoneal Carcinoma	Procedure: Hyperthermic Intraperitoneal Chemotherapy Procedure: cytoreductive surgery Drug: adjuvant chemotherapy	Phase 3

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 Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	310 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	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
Actual Study Start Date :	October 15, 2019
Estimated Primary Completion Date :	July 1, 2021
Estimated Study Completion Date :	July 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Ovarian cancer

MedlinePlus related topics: Fever Ovarian Cancer

Genetic and Rare Diseases Information Center resources: Ovarian Cancer Ovarian Epithelial Cancer Fallopian Tube Cancer

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Experimental group Cytoreductive surgery Hyperthermic Intraperitoneal Chemotherapy (HIPEC) with Docetaxel 75 mg/m^2 and cisplatin 75 mg/m^2 intraperitoneally in succession 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.	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 Name: HIPEC Procedure: cytoreductive surgery Cytoreductive surgery (CRS) is performed when Faggoti value is less than 6 via laparoscopic exploration. Other Name: CRS 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 Name: ACT
Active Comparator: Control group Cytoreductive surgery 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.	Procedure: cytoreductive surgery Cytoreductive surgery (CRS) is performed when Faggoti value is less than 6 via laparoscopic exploration. Other Name: CRS 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 Name: ACT

Arm

Intervention/treatment

Experimental: Experimental group

Cytoreductive surgery
Hyperthermic Intraperitoneal Chemotherapy (HIPEC) with Docetaxel 75 mg/m^2 and cisplatin 75 mg/m^2 intraperitoneally in succession
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.

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 Name: HIPEC

Procedure: cytoreductive surgery

Cytoreductive surgery (CRS) is performed when Faggoti value is less than 6 via laparoscopic exploration.

Other Name: CRS

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 Name: ACT

Active Comparator: Control group

Cytoreductive surgery
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.

Procedure: cytoreductive surgery

Cytoreductive surgery (CRS) is performed when Faggoti value is less than 6 via laparoscopic exploration.

Other Name: CRS

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 Name: ACT

Outcome Measures

Primary Outcome Measures :

Median recurrence-free survival [ Time Frame: 3 years ]
assess median recurrence-free survival during 3 years in both study arms

Secondary Outcome Measures :

Median overall survival [ Time Frame: 3 years ]
assess median overall survival during 3 years in both study arms
Median progression-free survival [ Time Frame: 3 years ]
assess median progression-free survival during 3 years in both study arms
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
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)

Eligibility Criteria

Information from the National Library of Medicine

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Layout table for eligibility information

Ages Eligible for Study:	18 Years to 70 Years (Adult, Older Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations