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

National Cancer Center (NCC)

Status and phase

Enrolling

Phase 3

Conditions

Epithelial Ovarian Cancer

Platinum Resistant

Recurrent Ovarian

Cytoreductive Surgery

HIPEC

Mitomycin

Treatments

Procedure: HIPEC

Study type

Interventional

Funder types

Other

Identifiers

NCT05316181

NCC2021-0334

Details and patient eligibility

About

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

Full description

The objective of this trial (KOV-HIPEC-02R) 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.

Enrollment

140 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.