Clinical trial NCT05316181: CRS & HIPEC for Platinum-Resistant Recurrent Ovarian Cancer (KOV-02R, RECOVER)
Official title: Randomized Phase III Trial of Cytoreductive Surgery (CRS) and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for Platinum-Resistant Recurrent Ovarian Cancer: KOV-02R - Resistant Cancer of Ovary (RECOVER)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
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
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
First posted: 2022-04-07
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled, open-label, multicenter phase III trial
Primary purpose: TREATMENT

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 with platinum-resistant recurrent epithelial ovarian cancer.

Eligibility 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.

Primary outcomes:
measure: Progression-free survival (PFS)
timeFrame: From randomization to time of first progression or death from any cause, whichever came first, assessed up to 5 years
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: From randomization to the date of death from any cause, assessed up to 5 years
measure: cancer-specific survival
timeFrame: From randomization to the date of death due to ovarian cancer, assessed up to 5 years
measure: Treatment-related adverse events
timeFrame: From randomization up to the end of treatment plus 6 weeks
measure: Health-related quality of life (QLQ C30)
timeFrame: Over the 5 year surveillance period
measure: Health-related quality of life (QLQ OV28)
timeFrame: Over the 5 year surveillance period
measure: Health-related quality of life (EQ-5D-5L)
timeFrame: Over the 5 year surveillance period
measure: Cost-effectiveness analysis
timeFrame: At time of completion of 5-year surveillance period
Other outcomes:
Locations:
city: Goyang-si
country: Korea, Republic of
facility: Myong Cheol Lim
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Mokdong Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam hospital
Study officials:
References: