Status:
RECRUITING
CRS & HIPEC for Platinum-Resistant Recurrent Ovarian Cancer (KOV-02R, RECOVER)
Lead Sponsor:
National Cancer Center, Korea
Conditions:
Epithelial Ovarian Cancer
Platinum Resistant
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
Platinum-resistant recurrent epithelial ovarian cancer randomizing with or without cytoreductive surgery + hyperthermic intraperitoneal chemotherapy (HIPEC): KOV-02R, RECOVER
Detailed 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 wit...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
April 7 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2029
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT05316181
Start Date
April 7 2022
End Date
December 31 2029
Last Update
January 31 2025
Active Locations (3)
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1
Myong Cheol Lim
Goyang-si, Gyeonggi-do, South Korea, 10408
2
Ewha Womans University Mokdong Hospital
Seoul, South Korea
3
Korea University Anam hospital
Seoul, South Korea