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A Randomized Prospective Trail of HIPEC in Recurrent Ovarian Cancer Patients With HRR Mutation

Primary Purpose

Ovarian Cancer, Epithelial Ovarian Cancer, Ovarian Cancer, Epithelial

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
CRS+HIPEC
CRS alone
Sponsored by
CAI Hongbing
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring Homologous Recombination Repair Gene Mutation, hyperthermic intraperitoneal chemotherapy, Epithelial Ovarian Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes 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
  • informed consent form signed

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 UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

HRR mt 1

HRR mt 2

HRR wt 3

HRR wt 4

Arm Description

Patients are HRR mutated type, will undergo CRS plus HIPEC and then go on to receive standard platinum-based combination doublet intravenous chemotherapy.

Patients are HRR mutated type, will undergo CRS and then go on to receive standard platinum-based combination doublet intravenous chemotherapy.

Patients are HRR wild type, will undergo CRS plus HIPEC and then go on to receive standard platinum-based combination doublet intravenous chemotherapy.

Patients are HRR wild type, will undergo CRS and then go on to receive standard platinum-based combination doublet intravenous chemotherapy.

Outcomes

Primary Outcome Measures

Progression-free Survival
The progression-free survival interval was the time between diagnosis and evidence of recurrent or progressive disease.

Secondary Outcome Measures

Overall Survival
The overall survival interval was the time between diagnosis and death or last follow-up.
DP9
The 9 months progression-free survival rate was the rate of no evidence of recurrent or progressive disease at the time of 9 months since histological diagnosis.
DP12
The 9 months progression-free survival rate was the rate of no evidence of recurrent or progressive disease at the time of 12 months since histological diagnosis.
Serious adverse events, SAEs
Serious adverse events occur within 30 days after surgery, measured with CTCAE 4.0

Full Information

First Posted
July 12, 2020
Last Updated
September 4, 2020
Sponsor
CAI Hongbing
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1. Study Identification

Unique Protocol Identification Number
NCT04473339
Brief Title
A Randomized Prospective Trail of HIPEC in Recurrent Ovarian Cancer Patients With HRR Mutation
Official Title
A Randomized Prospective Trail of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Recurrent Ovarian Cancer Patients With Mutations in Homologous Recombination Repair (HRR) Genes
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
August 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
CAI Hongbing

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
A phase III prospective study with the primary objective to investigate the benefit of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in ovarian cancer patients with mutations in homologous recombination repair (HRR) genes. The target population for this study is patients with recurrent ovarian, peritoneal or fallopian tube cancers undergoing Cytoreductive Surgery (CRS). Patients will be divided into two groups according to HRR genes mutation, each group will be further divided into two sub-groups with different intervention. Patients in Group A are HRR mutated type, sub-group 1 will undergo CRS plus HIPEC and then go on to receive standard platinum-based combination doublet intravenous chemotherapy, sub-group 2 will undergo CRS and then go on to intravenous chemotherapy. Patients in Group B are HRR wild type, sub-group 3 will undergo CRS plus HIPEC and then go on to receive standard platinum-based combination doublet intravenous chemotherapy, sub-group 4 will undergo CRS and then go on to intravenous chemotherapy. All patients will receive maintenance therapy with Niraparib after primary treatment. Prognostic information will be collected for investigation of survival benefits of patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer, Epithelial Ovarian Cancer, Ovarian Cancer, Epithelial, Hyperthermic Intraperitoneal Chemotherapy(HIPEC), Homologous Recombination Repair Gene Mutation
Keywords
Homologous Recombination Repair Gene Mutation, hyperthermic intraperitoneal chemotherapy, Epithelial Ovarian Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
280 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HRR mt 1
Arm Type
Experimental
Arm Description
Patients are HRR mutated type, will undergo CRS plus HIPEC and then go on to receive standard platinum-based combination doublet intravenous chemotherapy.
Arm Title
HRR mt 2
Arm Type
Experimental
Arm Description
Patients are HRR mutated type, will undergo CRS and then go on to receive standard platinum-based combination doublet intravenous chemotherapy.
Arm Title
HRR wt 3
Arm Type
Experimental
Arm Description
Patients are HRR wild type, will undergo CRS plus HIPEC and then go on to receive standard platinum-based combination doublet intravenous chemotherapy.
Arm Title
HRR wt 4
Arm Type
Experimental
Arm Description
Patients are HRR wild type, will undergo CRS and then go on to receive standard platinum-based combination doublet intravenous chemotherapy.
Intervention Type
Procedure
Intervention Name(s)
CRS+HIPEC
Intervention Description
Patients will undergo only CRS, HIPEC and IVCT.Patients will receive standard platinum-based combination doublet chemotherapy for 6-8 cycles after CRS and then followed by maintenance therapy. 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.
Intervention Type
Procedure
Intervention Name(s)
CRS alone
Intervention Description
Patients will undergo only CRS and IVCT.Patients will receive standard platinum-based combination doublet chemotherapy for 6-8 cycles after CRS and then followed by maintenance therapy.
Primary Outcome Measure Information:
Title
Progression-free Survival
Description
The progression-free survival interval was the time between diagnosis and evidence of recurrent or progressive disease.
Time Frame
up to 36 months since diagnosis
Secondary Outcome Measure Information:
Title
Overall Survival
Description
The overall survival interval was the time between diagnosis and death or last follow-up.
Time Frame
up to 36 months since histological diagnosis
Title
DP9
Description
The 9 months progression-free survival rate was the rate of no evidence of recurrent or progressive disease at the time of 9 months since histological diagnosis.
Time Frame
the 1 day of histological diagnosis and 9 months after
Title
DP12
Description
The 9 months progression-free survival rate was the rate of no evidence of recurrent or progressive disease at the time of 12 months since histological diagnosis.
Time Frame
the 1 day of histological diagnosis and 12 months after
Title
Serious adverse events, SAEs
Description
Serious adverse events occur within 30 days after surgery, measured with CTCAE 4.0
Time Frame
surgery and with in 30 days

10. Eligibility

Sex
Female
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 informed consent form signed 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hongbing Cai, Doctor
Phone
+86-27-67812648
Email
chb2105@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zhen Li, Doctor
Phone
+86-27-67812648
Facility Information:
Facility Name
Zhongnan Hospital of Wuhan University
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430070
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuanzhen Zhang, Doctor
Phone
+86-27-67812787
Email
znyyll@126.com

12. IPD Sharing Statement

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A Randomized Prospective Trail of HIPEC in Recurrent Ovarian Cancer Patients With HRR Mutation

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