Status:
UNKNOWN
Cytoreductive Surgery(CRS) Plus Hyperthermic Intraperitoneal Chemotherapy(HIPEC) With Lobaplatin in Advanced and Recurrent Epithelial Ovarian Cancer
Lead Sponsor:
Zhongnan Hospital
Conditions:
Ovarian Cancer
Ovary Neoplasm
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
A phase III prospective study with the primary objective to compare the efficacy and safety of HIPEC( Hyperthermic Intraperitoneal Chemotherapy). The target population for this study is patients with ...
Detailed Description
This is a phase III prospective study with the primary objective to compare the efficacy and safety of HIPEC. The target population for this study is patients with primary or recurrence ovarian, perit...
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
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 :
September 30 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 30 2023
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT03371693
Start Date
September 30 2017
End Date
March 30 2023
Last Update
May 29 2020
Active Locations (1)
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1
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China, 430072