HIPEC for Platinum-Resistant Recurrent Ovarian Cancer

Epithelial Ovarian Cancer Clinical Trial

— KOV-HIPEC-02  

Official title:

Randomized Phase III Trial of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for Platinum-Resistant Recurrent Ovarian Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05316181
• Other study ID #: NCC2021-0334
• Status: Recruiting
• Phase: Phase 3
• Start date: April 7, 2022
• Est. completion date: December 31, 2029

Study information

• Verified date: May 2023
• Source: National Cancer Center, Korea
• Contact: Myong Cheol Lim, MD, Ph.D
• Phone: +820319201760
• Email: mclim[@]ncc.re.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Platinum-resistant recurrent epithelial ovarian cancer randomizing with or without hyperthermic intraperitoneal chemotherapy (HIPEC)

Description:

The objective of this trial (KOV-HIPEC-02) is to prove the survival benefit of HIPEC with doxorubicin and mitomycin (trial arm) compared to physician-choice chemotherapy (control arm) in patients with platinum-resistant recurrent epithelial ovarian cancer.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: December 31, 2029
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

• Inclusion Criteria:

• Patients =18 years old,

• Patients with Eastern Cooperative Oncology Group (ECOG) Performance status 0-2,

• Patients diagnosed with histologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer,

• Resistant to platinum-based chemotherapy (Platinum-refractory or resistant disease)

• Resectable intraperitoneal disease based on previous clinical history and recent image finding,

• A life expectancy > 3 months as clinically judged,

• Women who are medically unable to conceive or who are of childbearing potential, agree to follow contraceptive guidelines during treatment,

• Patient 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 and,

• Adequate organ function for cytoreductive surgery and HIPEC

• Exclusion criteria:

• Non-epithelial ovarian carcinoma,

• Borderline ovarian tumor,

• Patients who are not appropriate for surgical and HIPEC procedures based on previous surgery or clinical findings, including severe intestinal adhesions, obstruction, or abdominal fistula,

• Patients with myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or with features suggestive of MDS/AML,

• Patients which extra-abdominal disease is a major disease or is expected to cause of death,

• 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,

• Patient diagnosed with a psychiatric disorder or substance abuse disorder that would interfere with your ability to cooperate with the trial,

• Patients who have not undergone hysterectomy and have a positive urine pregnancy test result within 14 days prior to clinical trial assignment, even if the urine pregnancy test result is negative at screening,

• Pregnant or lactating women,

• Patients with any contraindications to the use of doxorubicin or mitomycin (i.e., hypersensitivity to doxorubicin or mitomycin),

• 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, interfere with the patient's participation, in the opinion of the treating investigator.

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Epithelial Ovarian Cancer
• Ovarian Neoplasms

Intervention

Procedure:
• HIPEC
HIPEC perfusion, doxorubicin 35mg/m2 & mitomycin 15 mg/m2, 41.5'C, 90 min.

Locations

Country	Name	City	State
Korea, Republic of	Myong Cheol Lim	Goyang-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Center, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival (PFS)		From randomization to time of first progression or death from any cause, whichever came first, assessed up to 5 years
Secondary	Overall survival (OS)		From randomization to the date of death from any cause, assessed up to 5 years
Secondary	cancer-specific survival		From randomization to the date of death due to ovarian cancer, assessed up to 5 years
Secondary	Treatment-related adverse events	assessed by CTCAE ver.5.0	From randomization up to the end of treatment plus 6 weeks
Secondary	Health-related quality of life (QLQ C30)	assessed by EEuropean Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Score 30 (QLQ-C30)	Over the 5 year surveillance period
Secondary	Health-related quality of life (QLQ OV28)	assessed by European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Ovarian Cancer Module (QLQ-OV28)	Over the 5 year surveillance period
Secondary	Health-related quality of life (EQ-5D-5L)	assessed by the 5-level EQ-5D version (EQ-5D-5L)	Over the 5 year surveillance period
Secondary	Cost-effectiveness analysis	assessed by Quality-Adjusted Live Years (QALYs)	At time of completion of 5-year surveillance period