CRS & HIPEC for Platinum-Resistant Recurrent Ovarian Cancer (KOV-02R, RECOVER)

NCT05316181 | Active Not Recruiting Phase 3 FDA Drug FDA Device

• 1 other identifier: NCC2021-0334
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 3

Brief Summary

Platinum-resistant recurrent epithelial ovarian cancer randomizing with or without cytoreductive surgery + hyperthermic intraperitoneal chemotherapy (HIPEC): KOV-02R, RECOVER

Conditions

Epithelial Ovarian Cancer; Platinum Resistant; Recurrent Ovarian; HIPEC; Mitomycin; Cytoreductive Surgery

Keywords

Ovarian cancer; Hyperthermic intraperitoneal chemotherapy; HIPEC; Recurrent ovarian cancer; Cytoreductive surgery; Platinum-Resistant; Doxorubicin; Mitymycin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Overall survival (OS)

  From randomization to the date of death from any cause, assessed up to 5 years

• cancer-specific survival

  From randomization to the date of death due to ovarian cancer, assessed up to 5 years

• Treatment-related adverse events

  From randomization up to the end of treatment plus 6 weeks

• Health-related quality of life (QLQ C30)

  Over the 5 year surveillance period

• Health-related quality of life (QLQ OV28)

  Over the 5 year surveillance period

Study Arms (2)

Cytoreductive surgery and HIPEC

EXPERIMENTAL

Cytoreductive surgery + Hyperthermic Intraperitoneal Chemotherapy (HIPEC) followed by physician-choice chemotherapy until disease progression.

Procedure: HIPEC

No HIPEC

NO INTERVENTION

Physician-choice chemotherapy from enrollment until disease progression.

Interventions

HIPEC PROCEDURE

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

Cytoreductive surgery and HIPEC

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Cancer Center, Korea: lead

Study Sites (3)

Myong Cheol Lim

Goyang-si, Gyeonggi-do, 10408, South Korea

Location

Ewha Womans University Mokdong Hospital

Seoul, South Korea

Location

Korea University Anam hospital

Seoul, South Korea

Location

Related Publications (1)

• Kim JH, Park E, Park SY, Lim MC. A randomized, multicenter, open-label phase III trial of cytoreductive surgery and hyperthermic intraperitoneal chemotherapy in platinum-resistant recurrent ovarian cancer: a rationale and study design of the KOV-HIPEC-02 trial. Int J Gynecol Cancer. 2025 Apr;35(4):101630. doi: 10.1016/j.ijgc.2025.101630. Epub 2025 Jan 9.

  PMID: 39955184 DERIVED

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial; Ovarian Neoplasms

Interventions

Hyperthermic Intraperitoneal Chemotherapy

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Chemotherapy, Adjuvant; Combined Modality Therapy; Therapeutics; Drug Therapy; Hyperthermia, Induced

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Randomized controlled, open-label, multicenter phase III trial

Study Record Dates

• First Submitted: March 3, 2022
• First Posted: April 7, 2022
• Study Start: April 7, 2022
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2029
• Last Updated: February 12, 2026

Record last verified: 2025-12

Locations

KR (3)