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Cytoreductive Surgery(CRS) Plus Hyperthermic Intraperitoneal Chemotherapy(HIPEC) With Lobaplatin in Advanced and Recurrent Epithelial Ovarian Cancer (HIPECOV)

Primary Purpose

Ovarian Cancer, Ovary Neoplasm, Ovarian Neoplasms

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
HIPEC
CRS
IVCT
Sponsored by
Zhongnan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring hyperthermic intraperitoneal chemotherapy, epithelial ovarian cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age 18-75
  • Karnofsky performance status >50 or World Health Organization performance score < 2
  • primary or recurrence ovarian, peritoneal or fallopian tube epithelial cancer; first intra-abdominal recurrence without distant metastasis (including: unique resectable pleural metastasis which are platinum-sensitive; resectable single lymphatic metastasis retroperitoneal or inguinal)
  • preoperative platinum-based chemotherapy (carboplatin and paclitaxel, carboplatin and liposomal doxorubicin, gemcitabine, trabectedin or topotecan)
  • lesion can be removed completely or residual disease < 0.5 cm
  • last chemotherapy finished no more than 12 weeks after surgery
  • no hepatic function damage
  • white blood cell count ≥3.5*10^9/L; platelet count ≥80*10^9/L; Hemoglobin ≥90g/L
  • no contraindication of surgery and anesthesia
  • life expectancy ≥ 3 months

Exclusion Criteria:

  • age < 18 or >75
  • no history of other cancer
  • platinum allergy
  • distant metastasis
  • used anti-angiogenic drug within 8 weeks
  • possibility of more than two resection of alimentary canal
  • recurrence < 6 months after primary treatment
  • histologic type: non epithelial origin
  • infection out of control
  • follow-up unable to carry on (geographic or psychic)
  • cardiac insufficiency or respiratory insufficiency
  • has received HIPEC already
  • being in other clinical study
  • pregnancy or lactation period

Sites / Locations

  • Zhongnan Hospital of Wuhan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

HIPEC

Non HIPEC

Arm Description

Patients will undergo a CRS plus HIPEC and IVCT. Hyperthermic intraperitoneal chemotherapy (HIPEC) is a procedure in which the abdominal cavity is bathed in a warm solution of anti-cancer medications for 60 minutes. A single drug lobaplatin(30mg/m2)will be administered in normal saline via HIPEC and it will be continued for 60 minutes in the hyperthermic phase (41°C-43°C). HIPEC will be performed at the 1st, 3rd and 5th day after CRS. The intravenous chemotherapy(IVCT) will start from 7th-14th day after CRS.

Patients will undergo only CRS and IVCT. Patients will receive standard platinum-based combination doublet chemotherapy for 6-8 cycles after CRS.

Outcomes

Primary Outcome Measures

Overall Survival rate
assess overall survival rate in 5 years in both arms
1 year survival rate
assess the survival rate in 1 year for both arms
3 year survival rate
assess the survival rate in 3 years for both arms

Secondary Outcome Measures

Progression-free survival
assess the Progression-free survival rate during 5 years for both study arms
quality of life
Patients will fill the EORTC Quality of life questionaire-C30 form to measure the quality of life after a standard treatment.
postoperative complication
measured with physical examination and/or computed tomography（CT）and/or ultrasound examination.

Full Information

First Posted
November 27, 2017
Last Updated
May 28, 2020
Sponsor
Zhongnan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03371693
Brief Title
Cytoreductive Surgery(CRS) Plus Hyperthermic Intraperitoneal Chemotherapy(HIPEC) With Lobaplatin in Advanced and Recurrent Epithelial Ovarian Cancer
Acronym
HIPECOV
Official Title
A Phase III Clinical Trail of Cytoreductive Surgery(CRS) Plus Hyperthermic Intraperitoneal Chemotherapy(HIPEC) With Lobaplatin in Advanced and Recurrent Epithelial Ovarian Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 30, 2017 (Actual)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
March 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhongnan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
A phase III prospective study with the primary objective to compare the efficacy and safety of HIPEC( Hyperthermic Intraperitoneal Chemotherapy). The target population for this study is patients with primary or recurrence ovarian, peritoneal or fallopian tube cancers undergoing CRS( Cytoreductive Surgery). Patients will be divided into two groups. Group A will undergo CRS plus HIPEC and then go on to receive standard platinum-based combination doublet intravenous chemotherapy. Group B will undergo CRS and then go on to intravenous chemotherapy.
Detailed Description
This is a phase III prospective study with the primary objective to compare the efficacy and safety of HIPEC. The target population for this study is patients with primary or recurrence ovarian, peritoneal or fallopian tube cancers undergoing CRS. 'Platinum-sensitive' recurrence is defined as recurrence 6 months after the completion of the primary platinum-based chemotherapy. A single dose of lobaplatin 40mg/m2 will be administered via HIPEC , and will be administered at the time of surgery, 3 days after surgery and 5 days after surgery. Patients of group A will undergo CRS plus HIPEC and then go on to receive standard platinum-based combination doublet intravenous chemotherapy (carboplatin and paclitaxel, carboplatin and gemcitabine, or carboplatin and liposomal doxorubicin) for 6 cycles. Patients of group B will undergo CRS and then go on to intravenous chemotherapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer, Ovary Neoplasm, Ovarian Neoplasms, Epithelial Ovarian Cancer, Ovarian Cancer, Epithelial, Hyperthermic Intraperitoneal Chemotherapy(HIPEC)
Keywords
hyperthermic intraperitoneal chemotherapy, epithelial ovarian cancer

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
HIPEC
Arm Type
Experimental
Arm Description
Patients will undergo a CRS plus HIPEC and IVCT. Hyperthermic intraperitoneal chemotherapy (HIPEC) is a procedure in which the abdominal cavity is bathed in a warm solution of anti-cancer medications for 60 minutes. A single drug lobaplatin(30mg/m2)will be administered in normal saline via HIPEC and it will be continued for 60 minutes in the hyperthermic phase (41°C-43°C). HIPEC will be performed at the 1st, 3rd and 5th day after CRS. The intravenous chemotherapy(IVCT) will start from 7th-14th day after CRS.
Arm Title
Non HIPEC
Arm Type
Other
Arm Description
Patients will undergo only CRS and IVCT. Patients will receive standard platinum-based combination doublet chemotherapy for 6-8 cycles after CRS.
Intervention Type
Device
Intervention Name(s)
HIPEC
Intervention Description
Patients consenting to this protocol will undergo their scheduled surgical procedure. After cytoreductive surgery (CRS) to a residual disease ≤ 2.5 mm, a single dose of lobaplatin (30 mg/m2) will be administered in normal saline via intraperitoneal hyperthermic perfusion using the closed-abdomen technique. HIPEC will be continued for 60 minutes in the hyperthermic phase (43℃±0.5℃). And HIPEC will be repeated at the 3 and 5 day after the day of CRS plus HIPEC.
Intervention Type
Device
Intervention Name(s)
CRS
Intervention Description
cytoreductive surgery (CRS) to a residual disease ≤ 2.5 mm.
Intervention Type
Device
Intervention Name(s)
IVCT
Intervention Description
platinum-based intravenous chemotherapy
Primary Outcome Measure Information:
Title
Overall Survival rate
Description
assess overall survival rate in 5 years in both arms
Time Frame
5 years
Title
1 year survival rate
Description
assess the survival rate in 1 year for both arms
Time Frame
1 year
Title
3 year survival rate
Description
assess the survival rate in 3 years for both arms
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Progression-free survival
Description
assess the Progression-free survival rate during 5 years for both study arms
Time Frame
5 years
Title
quality of life
Description
Patients will fill the EORTC Quality of life questionaire-C30 form to measure the quality of life after a standard treatment.
Time Frame
5 years after CRS or until death
Title
postoperative complication
Description
measured with physical examination and/or computed tomography（CT）and/or ultrasound examination.
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age 18-75 Karnofsky performance status >50 or World Health Organization performance score < 2 primary or recurrence ovarian, peritoneal or fallopian tube epithelial cancer; first intra-abdominal recurrence without distant metastasis (including: unique resectable pleural metastasis which are platinum-sensitive; resectable single lymphatic metastasis retroperitoneal or inguinal) preoperative platinum-based chemotherapy (carboplatin and paclitaxel, carboplatin and liposomal doxorubicin, gemcitabine, trabectedin or topotecan) lesion can be removed completely or residual disease < 0.5 cm last chemotherapy finished no more than 12 weeks after surgery no hepatic function damage white blood cell count ≥3.5*10^9/L; platelet count ≥80*10^9/L; Hemoglobin ≥90g/L no contraindication of surgery and anesthesia life expectancy ≥ 3 months Exclusion Criteria: age < 18 or >75 no history of other cancer platinum allergy distant metastasis used anti-angiogenic drug within 8 weeks possibility of more than two resection of alimentary canal recurrence < 6 months after primary treatment histologic type: non epithelial origin infection out of control follow-up unable to carry on (geographic or psychic) cardiac insufficiency or respiratory insufficiency has received HIPEC already being in other clinical study pregnancy or lactation period
Facility Information:
Facility Name
Zhongnan Hospital of Wuhan University
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430072
Country
China

12. IPD Sharing Statement

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Cytoreductive Surgery(CRS) Plus Hyperthermic Intraperitoneal Chemotherapy(HIPEC) With Lobaplatin in Advanced and Recurrent Epithelial Ovarian Cancer

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