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

Fallopian Tube Cancer Clinical Trial

— EHTASEOCCS  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03373058
• Other study ID #: HIPEC-03
• Status: Recruiting
• Phase: Phase 3
• Start date: October 15, 2019
• Est. completion date: July 1, 2023

Study information

• Verified date: November 2019
• Source: Affiliated Cancer Hospital & Institute of Guangzhou Medical University
• Contact: Shuzhong Cui, M.D
• Phone: 0086-138-0251-3800
• Email: cuishuzhong[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 310
• Est. completion date: July 1, 2023
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

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.

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing
China	Chongqing Cancer Hospital	Chongqing
China	The First Affiliated Hospital of Chongqing Medical University	Chongqing
China	Affiliated Tumor Hospital of Guangzhou Medical University	Guangzhou	Guangdong
China	Sun Yat-sen Memorial Hospital,Sun Yat-sen University	Guanzhou	Guangdong
China	Hubei General Hospital	Wuhan
China	Henan Cancer Hospital	Zhengzhou

Sponsors (30)

Lead Sponsor

Collaborator

Affiliated Cancer Hospital & Institute of Guangzhou Medical University

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Median recurrence-free survival	assess median recurrence-free survival during 3 years in both study arms	3 years
Secondary	Median overall survival	assess median overall survival during 3 years in both study arms	3 years
Secondary	Median progression-free survival	assess median progression-free survival during 3 years in both study arms	3 years
Secondary	Risk factors for morbidity and mortality	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
Secondary	Quality of life for ovarian cancer	Evaluated according to European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Ovarian Cancer Module (QLQ-OV28)	3 years