Administration of Hyperthermic Intraperitoneal Chemotherapy in the General Ward

Not Applicable

Not yet recruiting

• Conditions: Epithelial Ovarian Cancer
• Interventions: Procedure: China Hyperthermic Intraperitoneal Chemotherapy(C-HIPEC)

• Registration Number: NCT06277947
• Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Brief Summary

Ovarian cancer is the most lethal gynecologic malignancy. The majority of patients get diagnosed with advanced disease with peritoneal dissemination.It has been demonstrated that the addition of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) to interval debulking surgery can improve the prognosis. The National Comprehensive Cancer Network (NCCN) treatment guideline has recommended HIPEC as a first-line treatment for patients with advanced ovarian cancer. However, the guideline recommended the "Dutch model" of HIPEC, which is limited for routinely being performed in China. So we propose a HIPEC treatment modality, the bedside closed HIPEC in the general ward (C-HIPEC), which is suitable for the clinical characteristics of China. The aim of this study was to evaluate the safety of this model as a way to lay the foundation for subsequent efficacy evaluation and clinical promotion.

Detailed Description

The Dutch Model is limited for the following reasons: 1) The HIPEC treatment requires to be done in the operating room, which means the operation time would be lengthened. 2) High rate of exposure to chemotherapeutic drugs among healthcare workers. 3) It has significant safety concerns because it does not take into account racial differences in drug toxicity. This study is an investigator-initiated prospective multicenter feasibility study with a non-inferiority design, so as to provide evidence-based medical evidence for the use of the C-HIPEC model as an alternative to the "Dutch model" in clinical practice in China.

Study Timeline

• Status Verified: 2024-02
• Study Start: 2024-02
• Study First Submitted: 2024-02-03
• Study First Submitted QC: 2024-02-18
• Last Update Submitted: 2024-02-18
• Study First Posted: 2024-02-26
• Last Update Posted: 2024-02-26
• Primary Completion: 2024-12
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 92

Inclusion Criteria

（The following conditions must be met at the same time）

1. Pathologically confirmed primary epithelial ovarian, fallopian tube, and primary peritoneal cancers in FIGO stages III-IV.
2. Previous neoadjuvant chemotherapy with platinum + vincristine and ≤ 4 courses of neoadjuvant chemotherapy.
3. The residual tumor diameter is ≤1 cm after interval debulking surgery, and the reason for receiving IDS is that the patient cannot tolerate PDS due to the poor condition or the PDS cannot achieve optimal cytoreduction due to high tumor burden.
4. Age from 18 to 70 years.
5. Bone marrow reserve was well functioning. Leukocytosis ≥ 3.0×10^9/L, neutrophilic granulocyte ≥ 1.5 × 10^9/L, platelet count ≥ 100 × 10^9/L, and hemoglobin ≥ 80 g/L.
6. Organs work well. AST ≤ 2.5 × ULN, ALT ≤ 2.5 × upper limit of normal(ULN), total serum bilirubin ≤ 1.5 × ULN, and creatinine ≤ 1.5 × ULN.
7. ECOG score 0-1.
8. Patients voluntarily sign an informed consent form

Exclusion Criteria

(None of which was eligible)

1. Patients diagnosed with other malignant tumors within 5 years (excluding skin and thyroid cancers).
2. Patient is allergic to erythroxylanes.
3. Patients treated with anticancer drugs in other clinical trials.
4. High risk of anastomotic fistula or intestinal obstruction assessed during interval debulking surgery.
5. Any situation of disease instability or potentially impact safety and adherence of patient.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
C-HIPEC arm	China Hyperthermic Intraperitoneal Chemotherapy(C-HIPEC)	Infuse paclitaxel (75mg/m\^2) and cisplatin (75mg/m\^2) at 43℃ through the two drainage tubes placed in the upper abdomen, using the two drainage tubes placed in the lower abdomen as the effluent tubes, with an infusion time of 90 minutes and an infusion rate of 500-600 mL/min. The first HIPEC with paclitaxel should be performed within 24 hours after cytoreductive surgery. The second HIPEC with cisplatin should be performed 24 hours after the completion of the first HIPEC. Intravenous sedatives such as diazoxide, or propofol at 2-6 ml/h should be administered during HIPEC treatment with continuous intravenous infusion by a pump，or intramuscular injection of 50 mg of pethidine.

Primary Outcome Measures

Name	Time	Method
The incidence of adverse events of grade 3-5	up to 3 weeks after C-HIPEC.	The adverse events would be graded according to Common Terminology Criteria for Adverse Events (CTCAE 5.0). The types and incidence of AEs will be recorded to evaluate the safety of C-HIPEC.

Secondary Outcome Measures

Name	Time	Method
Time to progress (TTP)	from the end of IV chemotherapy to 1 year after C-HIPEC or relapse	Disease progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1, or on the basis of an increase from baseline in the CA-125 level, whichever one of these two criteria was met first. The CA-125 will be tested before each chemotherapy session, and the radiographic examination will be done every 3 months since the end of IV chemotherapy.
Quality of life, QLQ-C30	1) within 2 weeks before C-HIPEC; 2) 1 week after C-HIPEC; 3) before each cycle of IV chemotherapy (each cycle is 28 days)	Quality of life is assessed by health-related quality-of-life questionnaires-the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30).
The Time to the First Subsequent Therapy，TTFST	C-HIPEC to the first subsequent IV chemotherapy	The Time to the First Subsequent Therapy

Trial Locations

Locations (1)

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University; 🇨🇳 Guangzhou, China