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)

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ 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

Locations
Other Locations
Republic of Korea
Myong Cheol Lim
RECRUITING
Goyang-si
Ewha Womans University Mokdong Hospital
RECRUITING
Seoul
Korea University Anam hospital
RECRUITING
Seoul
Contact Information
Primary
Myong Cheol Lim, MD, Ph.D
mclim@ncc.re.kr
+820319201760
Backup
Ji Hyun Kim, MD
jihyunkim@ncc.re.kr
+8201026835747
Time Frame
Start Date: 2022-04-07
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 140
Treatments
Experimental: Cytoreductive surgery and HIPEC
Cytoreductive surgery + Hyperthermic Intraperitoneal Chemotherapy (HIPEC) followed by physician-choice chemotherapy until disease progression.
No_intervention: No HIPEC
Physician-choice chemotherapy from enrollment until disease progression.
Related Therapeutic Areas
Sponsors
Leads: National Cancer Center, Korea

This content was sourced from clinicaltrials.gov

Similar Clinical Trials