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

Sponsor

National Cancer Center, Korea (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05827523

Collaborator

(none)

520

Enrollment

Location

Arms

92.1

Anticipated Duration (Months)

5.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Primary stage III-IV epithelial ovarian cancer randomizing between interval cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy (HIPEC)

Condition or Disease	Intervention/Treatment	Phase
Ovarian Cancer	Drug: Cisplatin	Phase 3

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

520 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized controlled, single-blinded, multicenter phase III trialRandomized controlled, single-blinded, multicenter phase III trial

Masking:

Double (Participant, Care Provider)

Masking Description:

Enrolled patients are unaware of which group they have been assigned to.

Primary Purpose:

Treatment

Official Title:

Phase III Randomized Trial of HIPEC in Primary Stage Three & Four Ovarian Cancer After Interval Cytoreductive Surgery (FOCUS)

Anticipated Study Start Date :

Apr 30, 2023

Anticipated Primary Completion Date :

Dec 31, 2027

Anticipated Study Completion Date :

Dec 31, 2030

Arms and Interventions

Arm	Intervention/Treatment
Experimental: HIPEC Interval cytoreductive surgery with HIPEC	Drug: Cisplatin Hyperthermic intraperitoneal chemotherapy (HIPEC) with cisplatin 75mg/m2 after interval cytoreductive surgery
No Intervention: No HIPEC Interval cytoreductive surgery without HIPEC

Arm

Intervention/Treatment

Experimental: HIPEC

Interval cytoreductive surgery with HIPEC

Drug: Cisplatin

Hyperthermic intraperitoneal chemotherapy (HIPEC) with cisplatin 75mg/m2 after interval cytoreductive surgery

No Intervention: No HIPEC

Interval cytoreductive surgery without HIPEC

Outcome Measures

Primary Outcome Measures

Overall survival (OS) [From randomization to the date of death from any cause, assessed up to 5 years]

Secondary Outcome Measures

Progression-free survival (PFS) [From randomization to time of first progression or death from any cause, whichever came first, assessed up to 5 years]
Cancer-specific survival [From randomization to the date of death due to ovarian cancer, assessed up to 5 years]
Time to first subsequent therapy (TFST) [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]
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 [From randomization up to the end of treatment plus 4 weeks]
assessed by CTCAE ver.5.0
Health-related quality of life (EORTC-QLQ-C30) [Over the 5 year surveillance period]
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) [Over the 5 year surveillance period]
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) [Over the 5 year surveillance period]
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 [At time of completion of 5-year surveillance period]
assessed by Quality-Adjusted Live Years (QALYs), incremental cost-effectiveness ratio (ICER)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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.