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

Primary Purpose

Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Hyperthermic Intraperitoneal Chemotherapy
cytoreductive surgery
adjuvant chemotherapy
Sponsored by
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epithelial Ovarian Cancer focused on measuring Hyperthermic Intraperitoneal Chemotherapy, Advanced-Stage Epithelial Ovarian Cancer, Cytoreductive surgery, Postoperative Chemotherapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Affiliated Tumor Hospital of Guangzhou Medical UniversityRecruiting
  • Sun Yat-sen Memorial Hospital,Sun Yat-sen UniversityRecruiting
  • Beijing Cancer HospitalRecruiting
  • Chongqing Cancer HospitalRecruiting
  • The First Affiliated Hospital of Chongqing Medical UniversityRecruiting
  • Hubei General HospitalRecruiting
  • Henan Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental group

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Median recurrence-free survival
assess median recurrence-free survival during 3 years in both study arms

Secondary Outcome Measures

Median overall survival
assess median overall survival during 3 years in both study arms
Median progression-free survival
assess median progression-free survival during 3 years in both study arms
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
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)

Full Information

First Posted
December 4, 2017
Last Updated
November 4, 2019
Sponsor
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
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
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1. Study Identification

Unique Protocol Identification Number
NCT03373058
Brief Title
Efficacy of HIPEC in the Treatment of Advanced-Stage Epithelial Ovarian Cancer After Cytoreductive Surgery
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 15, 2019 (Actual)
Primary Completion Date
July 1, 2021 (Anticipated)
Study Completion Date
July 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma
Keywords
Hyperthermic Intraperitoneal Chemotherapy, Advanced-Stage Epithelial Ovarian Cancer, Cytoreductive surgery, Postoperative Chemotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
310 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Hyperthermic Intraperitoneal Chemotherapy
Other Intervention Name(s)
HIPEC
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
cytoreductive surgery
Other Intervention Name(s)
CRS
Intervention Description
Cytoreductive surgery (CRS) is performed when Faggoti value is less than 6 via laparoscopic exploration.
Intervention Type
Drug
Intervention Name(s)
adjuvant chemotherapy
Other Intervention Name(s)
ACT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Median recurrence-free survival
Description
assess median recurrence-free survival during 3 years in both study arms
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Median overall survival
Description
assess median overall survival during 3 years in both study arms
Time Frame
3 years
Title
Median progression-free survival
Description
assess median progression-free survival during 3 years in both study arms
Time Frame
3 years
Title
Risk factors for morbidity and mortality
Description
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
Time Frame
30 days; 3 years
Title
Quality of life for ovarian cancer
Description
Evaluated according to European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Ovarian Cancer Module (QLQ-OV28)
Time Frame
3 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shuzhong Cui, M.D
Phone
0086-138-0251-3800
Email
cuishuzhong@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xian-Zi Yang, M.D
Phone
0086-188-9853-4167
Email
7097359@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shuzhong Cui, M.D
Organizational Affiliation
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Zhongqiu Lin, M.D
Organizational Affiliation
Sun Yat-sen Memorial Hospital,Sun Yat-sen University
Official's Role
Study Director
Facility Information:
Facility Name
Affiliated Tumor Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510095
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
shuzhong cui, M.D
Phone
0086-138-0251-3800
Email
cuishuzhong@126.com
First Name & Middle Initial & Last Name & Degree
Zhen Tang, M.M
Phone
0086-159-2081-9128
Email
57932181@qq.com
First Name & Middle Initial & Last Name & Degree
shuzhong cui, M.D
Facility Name
Sun Yat-sen Memorial Hospital,Sun Yat-sen University
City
Guanzhou
State/Province
Guangdong
ZIP/Postal Code
510235
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhongqiu Lin, MD
Phone
08613802921545
Email
lin-zhongqiu@163.com
First Name & Middle Initial & Last Name & Degree
Jing Li, MD
Facility Name
Beijing Cancer Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yunong Gao, MD
Phone
010-88196216
First Name & Middle Initial & Last Name & Degree
Qian Li, MD
Facility Name
Chongqing Cancer Hospital
City
Chongqing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qi Zhou, MD
Email
qizhou9128@163.com
First Name & Middle Initial & Last Name & Degree
Xingtao Long, MD
Facility Name
The First Affiliated Hospital of Chongqing Medical University
City
Chongqing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Junying Tang, MD
Email
tangjy_cqmu@sina.com
First Name & Middle Initial & Last Name & Degree
Lin Xiao, MD
Facility Name
Hubei General Hospital
City
Wuhan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
LI Hong, MD
Email
1072247562@qq.com
Facility Name
Henan Cancer Hospital
City
Zhengzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Wang, MD

12. IPD Sharing Statement

Learn more about this trial

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

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