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Trial Title:
Interval Cytoreductive Surgery With or Without HIPEC for Ovarian Cancer (KOV-HIPEC-04)
NCT ID:
NCT05827523
Condition:
Ovarian Cancer
Conditions: Official terms:
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Cisplatin
Conditions: Keywords:
Ovarian cancer
Hyperthermic intraperitoneal chemotherapy
HIPEC
Interval cytoreductive surgery
Neoadjuvant chemotherapy
Carcinoma, Ovarian Epithelial
Epithelial ovarian cancer
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Randomized controlled, single-blinded, multicenter phase III trial
Primary purpose:
Treatment
Masking:
Single (Participant)
Masking description:
Enrolled patients are unaware of which group they have been assigned to.
Intervention:
Intervention type:
Drug
Intervention name:
Cisplatin
Description:
Hyperthermic intraperitoneal chemotherapy (HIPEC) with cisplatin 75mg/m2 after interval
cytoreductive surgery
Arm group label:
HIPEC
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Signed and written informed consent,
2. Patients ≥18, <80 years old,
3. 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,
4. Treated with interval complete cytoreduction, or cytoreduction with no more than 2.5
mm depth of residual disease,
5. A life expectancy > 3 months as clinically judged,
6. Adequate organ function for cytoreductive surgery and HIPEC,
7. Women who are medically unable to conceive or who are of childbearing potential,
agree to follow contraceptive guidelines during treatment and,
8. 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:
1. Diagnosed with non-epithelial ovarian carcinoma or borderline ovarian tumor
2. Patients who have not undergone neoadjuvant chemotherapy,
3. Interval cytoreduction with more than 2.5 mm depth of residual disease,
4. A life expectancy ≤3 months as clinically judged,
5. 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,
6. Patients with myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or with
features suggestive of MDS/AML,
7. 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,
8. Patients with antibacterial, antifungal, or antiviral infections requiring systemic
treatment (administration of parenteral antibiotics),
9. Active tuberculosis that is not controlled within 1 month of treatment,
10. Patients diagnosed with a psychiatric disorder or substance abuse disorder that
would interfere with your ability to cooperate with the trial,
11. Patients with any contraindications to the use of cisplatin (i.e., hypersensitivity
to cisplatin),
12. Patients with a history of allogeneic tissue/solid organ transplantation or bone
marrow transplantation or a history of double umbilical cord transplantation or,
13. 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
National Cancer Center
Address:
City:
Goyang
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Myong Cheol Lim, MD, PhD
Phone:
+820319201760
Email:
gynlim@gmail.com
Contact backup:
Last name:
Ji Hyun Kim, MD
Email:
gynlittle@gmail.com
Investigator:
Last name:
Myong Cheol Lim
Email:
Principal Investigator
Start date:
May 31, 2023
Completion date:
December 31, 2030
Lead sponsor:
Agency:
National Cancer Center, Korea
Agency class:
Other
Source:
National Cancer Center, Korea
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05827523