RecruitingPhase 3NCT05827523

Interval Cytoreductive Surgery With or Without HIPEC for Ovarian Cancer (FOCUS / KOV-HIPEC-04)

Phase III Randomized Trial of HIPEC in Primary Stage Three & Four Primary Ovarian Cancer After Interval Cytoreductive Surgery (FOCUS, KOV-04)


Sponsor

National Cancer Center, Korea

Enrollment

520 participants

Start Date

May 31, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

Primary stage III-IV epithelial ovarian cancer randomizing between interval cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy (HIPEC)


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying whether adding a heated chemotherapy wash directly into the abdomen (called HIPEC) during interval surgery improves survival in women with advanced ovarian cancer who have already received three cycles of chemotherapy before surgery. **You may be eligible if...** - You are 18–79 years old - You have been diagnosed with advanced (stage III–IV) ovarian, fallopian tube, or primary peritoneal cancer confirmed by biopsy - You have completed three cycles of neoadjuvant chemotherapy - You have had or are scheduled for interval cytoreductive (debulking) surgery that achieved complete or near-complete removal of visible tumors - Your organ function is adequate for major surgery **You may NOT be eligible if...** - You have a non-epithelial ovarian cancer or a borderline tumor - You did not receive neoadjuvant chemotherapy - Your surgery left significant residual tumor (more than 2.5 mm depth) - You have a life expectancy of 3 months or less - You have another cancer diagnosed within the past 5 years (with limited exceptions) - You have active infections, active tuberculosis, or central nervous system metastases Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCisplatin

Hyperthermic intraperitoneal chemotherapy (HIPEC) with cisplatin 75mg/m2 after interval cytoreductive surgery


Locations(10)

Chungnam National University Hospital

Sejong, Chungcheongnam-do, South Korea

Chungnam National University Sejong Hospital

Sejong, Chungcheongnam-do, South Korea

Ilsan CHA University Hospital

Goyang-si, Gyeonggi-do, South Korea

National Cancer Center

Goyang-si, Gyeonggi-do, South Korea

Ajou University Hospital

Suwon, Gyeonggi-do, South Korea

Pusan National University Hospital

Pusan, South Korea

Pusan National University Yangsan Hospital

Pusan, South Korea

Asan Medical Center

Seoul, South Korea

Ewha Womans University Mokdong Hospital

Seoul, South Korea

Severance Hospital

Seoul, South Korea

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT05827523


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