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Interval Cytoreductive Surgery With or Without HIPEC for Ovarian Cancer (KOV-HIPEC-04)

Primary Purpose

Ovarian Cancer

Status
Recruiting
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Cisplatin
Sponsored by
National Cancer Center, Korea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring Ovarian cancer, Hyperthermic intraperitoneal chemotherapy, HIPEC, Interval cytoreductive surgery, Neoadjuvant chemotherapy, Carcinoma, Ovarian Epithelial, Epithelial ovarian cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Signed and written informed consent, Patients ≥18, <80 years old, Diagnosed with histologically confirmed FIGO stage III-IV primary epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer treated with three cycles of neoadjuvant chemotherapy, Treated with interval complete cytoreduction, or cytoreduction with no more than 2.5 mm depth of residual disease, A life expectancy > 3 months as clinically judged, Adequate organ function for cytoreductive surgery and HIPEC, Women who are medically unable to conceive or who are of childbearing potential, agree to follow contraceptive guidelines during treatment and, Patients can also consent to the provision of clinical information for secondary use, such as future biomedical research. However, in the future, subjects can participate in the main trial even if they do not intend to participate in sharing clinical information. Exclusion Criteria: Diagnosed with non-epithelial ovarian carcinoma or borderline ovarian tumor Patients who have not undergone neoadjuvant chemotherapy, Interval cytoreduction with more than 2.5 mm depth of residual disease, A life expectancy ≤3 months as clinically judged, History of previous malignancy within five years prior to inclusion, that affects ovarian cancer treatment results, with the exception of carcinoma in situ, radically excised basal cell or squamous cell cancer of the skin, or synchronal endometrial carcinoma FIGO IA G1/2, Patients with myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or with features suggestive of MDS/AML, Patients with active central nervous system metastasis and carcinoma meningitis or patients who have been previously treated for brain metastases must be in a stable state in radiology, Patients with antibacterial, antifungal, or antiviral infections requiring systemic treatment (administration of parenteral antibiotics), Active tuberculosis that is not controlled within 1 month of treatment, Patients diagnosed with a psychiatric disorder or substance abuse disorder that would interfere with your ability to cooperate with the trial, Patients with any contraindications to the use of cisplatin (i.e., hypersensitivity to cisplatin), Patients with a history of allogeneic tissue/solid organ transplantation or bone marrow transplantation or a history of double umbilical cord transplantation or, History or current evidence of any condition, therapy, or laboratory abnormality that may confound the results of the study, or interfere with the patient's participation, in the opinion of the treating investigator.

Sites / Locations

  • National Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

HIPEC

No HIPEC

Arm Description

Interval cytoreductive surgery with HIPEC

Interval cytoreductive surgery without HIPEC

Outcomes

Primary Outcome Measures

Overall survival (OS)

Secondary Outcome Measures

Progression-free survival (PFS)
Cancer-specific survival
Time to first subsequent therapy (TFST)
the interval from the last day of the last cycle of a prior regimen of chemotherapy to the first day of the first cycle of the subsequent regimen for each course of chemotherapy
Treatment-related adverse events
assessed by CTCAE ver.5.0
Health-related quality of life (EORTC-QLQ-C30)
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status.
Health-related quality of life (EORTC-QLQ-OV28)
The EORTC QLQ-OV28 is a specified questionnaire for patients with ovarian cancer. Participant responses to the question are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized so that scores range from 0 to 100. A lower score indicates a better outcome.
Health-related quality of life (EQ-5D-5L)
Each dimension in the EQ-5D-5L has five response levels: no problems (Level 1); slight; moderate; severe; and extreme problems (Level 5).
Cost-effectiveness analysis
assessed by Quality-Adjusted Live Years (QALYs), incremental cost-effectiveness ratio (ICER)

Full Information

First Posted
April 12, 2023
Last Updated
May 31, 2023
Sponsor
National Cancer Center, Korea
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1. Study Identification

Unique Protocol Identification Number
NCT05827523
Brief Title
Interval Cytoreductive Surgery With or Without HIPEC for Ovarian Cancer (KOV-HIPEC-04)
Official Title
Phase III Randomized Trial of HIPEC in Primary Stage Three & Four Ovarian Cancer After Interval Cytoreductive Surgery (FOCUS)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 31, 2023 (Actual)
Primary Completion Date
December 31, 2027 (Anticipated)
Study Completion Date
December 31, 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cancer Center, Korea

4. Oversight

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

5. Study Description

Brief Summary
Primary stage III-IV epithelial ovarian cancer randomizing between interval cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy (HIPEC)
Detailed Description
The goal of this phase III randomized controlled trial is to compare the clinical efficacy of HIPEC with cisplatin (trial arm) compared to no HIPEC (control arm) during interval cytoreductive surgery followed by neoadjuvant chemotherapy, in patients with stage III-IV primary epithelial ovarian cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer
Keywords
Ovarian cancer, Hyperthermic intraperitoneal chemotherapy, HIPEC, Interval cytoreductive surgery, Neoadjuvant chemotherapy, Carcinoma, Ovarian Epithelial, Epithelial ovarian cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled, single-blinded, multicenter phase III trial
Masking
Participant
Masking Description
Enrolled patients are unaware of which group they have been assigned to.
Allocation
Randomized
Enrollment
520 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HIPEC
Arm Type
Experimental
Arm Description
Interval cytoreductive surgery with HIPEC
Arm Title
No HIPEC
Arm Type
No Intervention
Arm Description
Interval cytoreductive surgery without HIPEC
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
Hyperthermic intraperitoneal chemotherapy (HIPEC) with cisplatin 75mg/m2 after interval cytoreductive surgery
Primary Outcome Measure Information:
Title
Overall survival (OS)
Time Frame
From randomization to the date of death from any cause, assessed up to 5 years
Secondary Outcome Measure Information:
Title
Progression-free survival (PFS)
Time Frame
From randomization to time of first progression or death from any cause, whichever came first, assessed up to 5 years
Title
Cancer-specific survival
Time Frame
From randomization to the date of death due to ovarian cancer, assessed up to 5 years
Title
Time to first subsequent therapy (TFST)
Description
the interval from the last day of the last cycle of a prior regimen of chemotherapy to the first day of the first cycle of the subsequent regimen for each course of chemotherapy
Time Frame
from the last day of the last cycle of a prior regimen of chemotherapy to the first day of the first cycle of the subsequent chemotherapy, assessed up to 5 years
Title
Treatment-related adverse events
Description
assessed by CTCAE ver.5.0
Time Frame
From randomization up to the end of treatment plus 4 weeks
Title
Health-related quality of life (EORTC-QLQ-C30)
Description
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status.
Time Frame
Over the 5 year surveillance period
Title
Health-related quality of life (EORTC-QLQ-OV28)
Description
The EORTC QLQ-OV28 is a specified questionnaire for patients with ovarian cancer. Participant responses to the question are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized so that scores range from 0 to 100. A lower score indicates a better outcome.
Time Frame
Over the 5 year surveillance period
Title
Health-related quality of life (EQ-5D-5L)
Description
Each dimension in the EQ-5D-5L has five response levels: no problems (Level 1); slight; moderate; severe; and extreme problems (Level 5).
Time Frame
Over the 5 year surveillance period
Title
Cost-effectiveness analysis
Description
assessed by Quality-Adjusted Live Years (QALYs), incremental cost-effectiveness ratio (ICER)
Time Frame
At time of completion of 5-year surveillance period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signed and written informed consent, Patients ≥18, <80 years old, Diagnosed with histologically confirmed FIGO stage III-IV primary epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer treated with three cycles of neoadjuvant chemotherapy, Treated with interval complete cytoreduction, or cytoreduction with no more than 2.5 mm depth of residual disease, A life expectancy > 3 months as clinically judged, Adequate organ function for cytoreductive surgery and HIPEC, Women who are medically unable to conceive or who are of childbearing potential, agree to follow contraceptive guidelines during treatment and, Patients can also consent to the provision of clinical information for secondary use, such as future biomedical research. However, in the future, subjects can participate in the main trial even if they do not intend to participate in sharing clinical information. Exclusion Criteria: Diagnosed with non-epithelial ovarian carcinoma or borderline ovarian tumor Patients who have not undergone neoadjuvant chemotherapy, Interval cytoreduction with more than 2.5 mm depth of residual disease, A life expectancy ≤3 months as clinically judged, History of previous malignancy within five years prior to inclusion, that affects ovarian cancer treatment results, with the exception of carcinoma in situ, radically excised basal cell or squamous cell cancer of the skin, or synchronal endometrial carcinoma FIGO IA G1/2, Patients with myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or with features suggestive of MDS/AML, Patients with active central nervous system metastasis and carcinoma meningitis or patients who have been previously treated for brain metastases must be in a stable state in radiology, Patients with antibacterial, antifungal, or antiviral infections requiring systemic treatment (administration of parenteral antibiotics), Active tuberculosis that is not controlled within 1 month of treatment, Patients diagnosed with a psychiatric disorder or substance abuse disorder that would interfere with your ability to cooperate with the trial, Patients with any contraindications to the use of cisplatin (i.e., hypersensitivity to cisplatin), Patients with a history of allogeneic tissue/solid organ transplantation or bone marrow transplantation or a history of double umbilical cord transplantation or, History or current evidence of any condition, therapy, or laboratory abnormality that may confound the results of the study, or interfere with the patient's participation, in the opinion of the treating investigator.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Myong Cheol Lim, MD, Ph.D
Phone
+820319201760
Email
gynlim@gmail.com
Facility Information:
Facility Name
National Cancer Center
City
Goyang
State/Province
Gyeonggi
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Myong Cheol Lim, MD, PhD
Phone
+820319201760
Email
gynlim@gmail.com
First Name & Middle Initial & Last Name & Degree
Ji Hyun Kim, MD
Email
gynlittle@gmail.com
First Name & Middle Initial & Last Name & Degree
Myong Cheol Lim

12. IPD Sharing Statement

Plan to Share IPD
No

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Interval Cytoreductive Surgery With or Without HIPEC for Ovarian Cancer (KOV-HIPEC-04)

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