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

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
Interval debulking surgery
neoadjuvant chemotherapy
adjuvant chemotherapy
Sponsored by
Shu-Zhong Cui
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, Neoadjuvant Chemotherapy, Interval Debulking Surgery, Advanced-Stage Epithelial Ovarian Cancer, 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 and IV)
  • Fagotti score by laparoscopic exploration >= 6
  • After receiving HIPEC+neoadjuvant chemotherapy (NACT) or NACT alone, the curative effects evaluated according to RICIST criteria is partial remission (PR) and stable disease (SD).
  • Residual tumor < 1cm after completion of interval debulking 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
  • After receiving HIPEC+neoadjuvant chemotherapy (NACT) or NACT alone, the progression of disease (PD) is evaluated by doctor.
  • 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

  • Department of Abdominal Surgery (Section 2), Affiliated Tumor Hospital of Guangzhou Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental group

Control group

Arm Description

Hyperthermic Intraperitoneal Chemotherapy (HIPEC) with paclitaxel 175 mg/m^2 and cisplatin 75 mg/m^2 intraperitoneally in succession 2 cycles of neoadjuvant chemotherapy: paclitaxel 175 mg/m^2 IV>3 hour+ carboplatin AUC = 5-6 IV>1 hour, every 3 weeks Interval debulking surgery Hyperthermic Intraperitoneal Chemotherapy (HIPEC) with paclitaxel 175 mg/m^2 and cisplatin 75 mg/m^2 intraperitoneally in succession 2 cycles of adjuvant chemotherapy: paclitaxel 175 mg/m^2 IV>3 hour+ carboplatin AUC = 5-6 IV>1 hour, every 3 weeks

3 cycles of neoadjuvant chemotherapy: paclitaxel 175 mg/m^2 IV>3 hour+ carboplatin AUC = 5-6 IV>1 hour, every 3 weeks Interval debulking surgery 3 cycles of adjuvant chemotherapy: paclitaxel 175 mg/m^2 IV>3 hour+ carboplatin AUC = 5-6 IV>1 hour, every 3 weeks

Outcomes

Primary Outcome Measures

PR/SD rate
calculate the percent of partial remission (PR) plus stable disease (SD) of patients received HIPEC+NACT or NACT alone in both two arms
Percentage of optimal debulking surgery
evaluate the percentage of optimal debulk (residual disease < 1cm) after interval debulking surgery between study arms
Disease-free survival rate
assess disease free survival rate during 3 years in both study arms

Secondary Outcome Measures

Overall survival rate
assess overall survival rate during 3 years in both study arms
Risk factors for morbidity and mortality
determine percent of patients wtih Grade I-IV adverse events according to NCI criteria, Common Terminology Criteria for AE (CTCAE 4.0).
Quality of life
Evaluated according to European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Cancer (EORTC QLQ-C30)
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
June 6, 2017
Last Updated
January 22, 2018
Sponsor
Shu-Zhong Cui
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 Cancer Institute, Wuhan Union Hospital, China, Xinqiao Hospital of Chongqing
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1. Study Identification

Unique Protocol Identification Number
NCT03180177
Brief Title
Efficacy of HIPEC as NACT and Postoperative Chemotherapy in the Treatment of Advanced-Stage Epithelial Ovarian Cancer
Acronym
EHNPCTASEOC
Official Title
A Phase III Multicenter Prospective Randomized Controlled Clinical Trial of HIPEC as NACT and Postoperative Chemotherapy After Interval Debulking Surgery in the Treatment of Advanced-Stage Epithelial Ovarian Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2018 (Anticipated)
Primary Completion Date
July 1, 2021 (Anticipated)
Study Completion Date
July 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Shu-Zhong Cui
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 Cancer Institute, Wuhan Union Hospital, China, Xinqiao Hospital of Chongqing

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 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.
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 a high perioperative risk profile or a low likelihood of achieving cytoreduction to < 1 cm of residual disease (ideally to novisible disease) should receive neoadjuvant chemotherapy. Hyperthermia promotes chemotherapy to penetrate deeper into the cancer tissue. Therefore, hyperthermic intraperitoneal chemotherapy (HIPEC) as neoadjuvant chemotherapy and postoperative chemotherapy after interval debulking 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, Neoadjuvant Chemotherapy, Interval Debulking Surgery, Advanced-Stage Epithelial Ovarian Cancer, Postoperative Chemotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
263 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Hyperthermic Intraperitoneal Chemotherapy (HIPEC) with paclitaxel 175 mg/m^2 and cisplatin 75 mg/m^2 intraperitoneally in succession 2 cycles of neoadjuvant chemotherapy: paclitaxel 175 mg/m^2 IV>3 hour+ carboplatin AUC = 5-6 IV>1 hour, every 3 weeks Interval debulking surgery Hyperthermic Intraperitoneal Chemotherapy (HIPEC) with paclitaxel 175 mg/m^2 and cisplatin 75 mg/m^2 intraperitoneally in succession 2 cycles of adjuvant chemotherapy: paclitaxel 175 mg/m^2 IV>3 hour+ carboplatin AUC = 5-6 IV>1 hour, every 3 weeks
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
3 cycles of neoadjuvant chemotherapy: paclitaxel 175 mg/m^2 IV>3 hour+ carboplatin AUC = 5-6 IV>1 hour, every 3 weeks Interval debulking surgery 3 cycles of adjuvant chemotherapy: paclitaxel 175 mg/m^2 IV>3 hour+ 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 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.
Intervention Type
Procedure
Intervention Name(s)
Interval debulking surgery
Other Intervention Name(s)
IDS
Intervention Description
Cytoreductive surgery (CRS) is performed after neoadjuvant chemotherapy.
Intervention Type
Drug
Intervention Name(s)
neoadjuvant chemotherapy
Other Intervention Name(s)
NACT
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 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.
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
PR/SD rate
Description
calculate the percent of partial remission (PR) plus stable disease (SD) of patients received HIPEC+NACT or NACT alone in both two arms
Time Frame
Through study completion, an average of 1 year
Title
Percentage of optimal debulking surgery
Description
evaluate the percentage of optimal debulk (residual disease < 1cm) after interval debulking surgery between study arms
Time Frame
Through study completion, an average of 1 year
Title
Disease-free survival rate
Description
assess disease free survival rate during 3 years in both study arms
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Overall survival rate
Description
assess overall survival rate during 3 years in both study arms
Time Frame
3 years
Title
Risk factors for morbidity and mortality
Description
determine percent of patients wtih Grade I-IV adverse events according to NCI criteria, Common Terminology Criteria for AE (CTCAE 4.0).
Time Frame
Through study completion, an average of 1 year
Title
Quality of life
Description
Evaluated according to European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Cancer (EORTC QLQ-C30)
Time Frame
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 and IV) Fagotti score by laparoscopic exploration >= 6 After receiving HIPEC+neoadjuvant chemotherapy (NACT) or NACT alone, the curative effects evaluated according to RICIST criteria is partial remission (PR) and stable disease (SD). Residual tumor < 1cm after completion of interval debulking 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 After receiving HIPEC+neoadjuvant chemotherapy (NACT) or NACT alone, the progression of disease (PD) is evaluated by doctor. 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
Xianzi 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
Department of Abdominal Surgery (Section 2), Affiliated Tumor Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510095
Country
China
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
Xianzi Yang, M.D
Phone
0086-188-9853-4167
Email
7097359@qq.com
First Name & Middle Initial & Last Name & Degree
shuzhong cui, M.D

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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