HIPEC in the Treatment of Stage IIc-IV Epithelial Ovarian Cancer After CRS (HIPECOC)
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|ClinicalTrials.gov Identifier: NCT04280185|
Recruitment Status : Not yet recruiting
First Posted : February 21, 2020
Last Update Posted : February 21, 2020
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer Hyperthermic Intraperitoneal Chemotherapy||Procedure: Hyperthermic Intraperitoneal Chemotherapy||Not Applicable|
Advanced epithelial ovarian cancer, now recognized as the most effective treatment is maximizing tumor reduction (cytoreductice surgery, CRS) within the abdominal cavity with platinum-based chemotherapy (intraperitoneal chemotherapy, IPEC) or intravenous chemotherapy.
Hyperthermic intraperitoneal chemotherapy (HIPEC) refers to the chemotherapy drugs will be diluted and heated to the specified temperature (usually the 42 degrees), then injected into the abdominal cavity, maintain a constant temperature, repeated perfusion filling, so as to achieve the purpose of prevention and treatment of intra-abdominal tumors of a way of treatment.
CRS combined with HIPEC is the most effective treatment strategy for peritoneal cancer at present.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||202 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Multicenter Prospective Randomized Controlled Clinical Trial of Hyperthermic Intraperitoneal Chemotherapy in the Treatment of Stage IIc-IV Epithelial Ovarian Cancer After Primary Cytoreductive Surgery|
|Estimated Study Start Date :||June 1, 2020|
|Estimated Primary Completion Date :||June 1, 2022|
|Estimated Study Completion Date :||June 1, 2024|
Experimental: Hyperthermic Intraperitoneal chemotherapy
Hyperthermic Intraperitoneal chemotherapy was started immediately after CRS, or the first HIPEC was completed within 48 hours after surgery: temperature 43℃, duration 60 minutes, Paclitaxel (60mg/m2) was selected. The second HIEPC was completed 7 days after the first HIPEC: temperature 43℃, duration 60min, carboplatin AUC (5-6) was selected. 30 minutes before using Paclitaxel, 10ML saline + 10mg dexamethasone intravenous infusion, 20mg diphenhyramine intramuscular injection, and 100ML saline + 0.3g cimetidine intravenous infusion. On the eighth day, intravenous chemotherapy with Paclitaxel (135mg/m2) was finally completed. 5 courses of TC intravenous chemotherapy were performed after 3 weeks
Procedure: Hyperthermic Intraperitoneal Chemotherapy
HIPEC is a way of intraperitoneal chemotherapy
No Intervention: intravenous chemotherapy
intravenous chemotherapy were performed 6 Cycles after CRS. Paclitaxel: 175mg/m2, iv infusion, no less than 3h per infusion, followed by carboplatin: AUC 5-6, iv infusion, no less than 1h per infusion, 1 dose on the first day of a week, 1 cycle every 3 weeks, a total of 6 cycles. Paclitaxel should be pretreated to prevent severe allergic reactions.
- To evaluate the progression-free survival (PFS) of patients with advanced ovarian cancer undergoing primary tumor cell depletion (HIPEC) during surgery. [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months ]From the date of random enrollment to the date of tumor progression or death. The appearance of the new lesion was taken as the criterion of progression, and the date of the first measurable observation of the new lesion was the marker of progression.ovarian cancer undergoing primary tumor cell depletion (HIPEC) during surgery.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04280185
|Contact: XUEJUN CHEN||+86 0571 firstname.lastname@example.org|
|Contact: JIONG MA||+86 0571 89713634|
|Principal Investigator:||JIONG MA||2nd Affiliated Hospital, School of Medicine, Zhejiang University, China|