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

Launched by NATIONAL CANCER CENTER, KOREA · Mar 30, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for women with recurrent ovarian cancer that has not responded to standard platinum-based chemotherapy. The trial is testing whether adding a special type of heated chemotherapy, called hyperthermic intraperitoneal chemotherapy (HIPEC), to surgery can improve outcomes for patients. Participants will be randomly assigned to receive either the standard treatment or the treatment that includes HIPEC.

To be eligible for this trial, participants must be at least 18 years old and have been diagnosed with certain types of ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. They should also have cancer that is resistant to platinum-based chemotherapy and have cancer that can be surgically removed. Participants can expect to undergo surgery, and if they qualify, they will receive either standard treatment or the new treatment involving HIPEC. It's important for potential participants to know that they must meet specific health criteria and agree to certain guidelines during the trial, including those related to pregnancy. The trial is currently recruiting participants, and it aims to provide more options for women facing this challenging disease.

Gender

FEMALE

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.