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

Last updated: January 29, 2025
Sponsor: National Cancer Center, Korea
Overall Status: Active - Recruiting

Phase

3

Condition

Ovarian Cysts

Treatment

HIPEC

Clinical Study ID

NCT05316181
NCC2021-0334
  • Ages > 18
  • Female

Study Summary

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

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 resistantdisease)

  • Resectable intraperitoneal disease based on previous clinical history andrecent image finding,

  • A life expectancy > 3 months as clinically judged,

  • Women who are medically unable to conceive or who are of childbearingpotential, agree to follow contraceptive guidelines during treatment,

  • Patient can also consent to the provision of clinical information for secondaryuse such as future biomedical research. However, in the future, subjects canparticipate in the main trial even if they do not intend to participate insharing clinical information and,

  • Adequate organ function for cytoreductive surgery and HIPEC

Exclusion

  • Exclusion criteria:

  • Non-epithelial ovarian carcinoma,

  • Borderline ovarian tumor,

  • Patients who are not appropriate for surgical and HIPEC procedures based onprevious surgery or clinical findings, including severe intestinal adhesions,obstruction, or abdominal fistula,

  • Patients with myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) orwith features suggestive of MDS/AML,

  • Patients which extra-abdominal disease is a major disease or is expected tocause of death,

  • Patients with active central nervous system metastasis and carcinoma meningitisor patients who have been previously treated for brain metastases must be in astable state in radiology,

  • Patients with antibacterial, antifungal, or antiviral infections requiringsystemic 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 thatwould interfere with your ability to cooperate with the trial,

  • Patients who have not undergone hysterectomy and have a positive urinepregnancy test result within 14 days prior to clinical trial assignment, evenif 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 orbone marrow transplantation or a history of double umbilical cordtransplantation or,

  • History or current evidence of any condition, therapy, or laboratoryabnormality that may confound the results of the study, interfere with thepatient's participation, in the opinion of the treating investigator.

Study Design

Total Participants: 140
Treatment Group(s): 1
Primary Treatment: HIPEC
Phase: 3
Study Start date:
April 07, 2022
Estimated Completion Date:
December 31, 2029

Study 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.

Connect with a study center

  • Myong Cheol Lim

    Goyang-si, Gyeonggi-do 10408
    Korea, Republic of

    Active - Recruiting

  • Ewha Womans University Mokdong Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Korea University Anam hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

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