Status:
UNKNOWN
A Randomized Prospective Trail of HIPEC in Recurrent Ovarian Cancer Patients With HRR Mutation
Lead Sponsor:
CAI Hongbing
Conditions:
Ovarian Cancer
Epithelial Ovarian Cancer
Eligibility:
FEMALE
18-75 years
Phase:
PHASE3
Brief Summary
A phase III prospective study with the primary objective to investigate the benefit of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in ovarian cancer patients with mutations in homologous recombi...
Eligibility Criteria
Inclusion
- age 18-75
- Karnofsky performance status \>50 or World Health Organization performance score \< 2
- primary or recurrence ovarian, peritoneal or fallopian tube epithelial cancer; first intra-abdominal recurrence without distant metastasis (including: unique resectable pleural metastasis which are platinum-sensitive; resectable single lymphatic metastasis retroperitoneal or inguinal)
- preoperative platinum-based chemotherapy (carboplatin and paclitaxel, carboplatin and liposomal doxorubicin, gemcitabine, trabectedin or topotecan)
- lesion can be removed completely or residual disease \< 0.5 cm
- last chemotherapy finished no more than 12 weeks after surgery
- no hepatic function damage
- white blood cell count ≥3.5\*10\^9/L; platelet count ≥80\*10\^9/L; Hemoglobin ≥90g/L
- no contraindication of surgery and anesthesia
- life expectancy ≥ 3 months
- informed consent form signed
Exclusion
- age \< 18 or \>75
- no history of other cancer
- platinum allergy
- distant metastasis
- used anti-angiogenic drug within 8 weeks
- possibility of more than two resection of alimentary canal
- recurrence \< 6 months after primary treatment
- histologic type: non epithelial origin
- infection out of control
- follow-up unable to carry on (geographic or psychic)
- cardiac insufficiency or respiratory insufficiency
- has received HIPEC already
- being in other clinical study
- pregnancy or lactation period
Key Trial Info
Start Date :
August 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2023
Estimated Enrollment :
280 Patients enrolled
Trial Details
Trial ID
NCT04473339
Start Date
August 1 2020
End Date
December 30 2023
Last Update
September 9 2020
Active Locations (1)
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1
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China, 430070