Clinical trial NCT06277947: Administration of Hyperthermic Intraperitoneal Chemotherapy in the General Ward
Official title: Administration of Hyperthermic Intraperitoneal Chemotherapy in the General Ward: a Multicenter, Prospective, Feasibility Study (GARD-HIPEC Study)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Epithelial Ovarian Cancer
Keywords: Epithelial Ovarian Cancer
Hyperthermic Intraperitoneal Chemotherapy
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
Collaborators: name: Shenshan Medical Center, Memorial Hospital of Sun Yat-sen University
First posted: 2024-02-26
Enrollment: 92
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients would receive C-HIPEC in the general ward after interval debulking surgery in 24 hours.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The incidence of adverse events of grade 3-5
timeFrame: up to 3 weeks after C-HIPEC.
Secondary outcomes:
measure: Time to progress (TTP)
timeFrame: from the end of IV chemotherapy to 1 year after C-HIPEC or relapse
measure: The Time to the First Subsequent Therapy，TTFST
timeFrame: C-HIPEC to the first subsequent IV chemotherapy
measure: Quality of life, QLQ-C30
timeFrame: 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)
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study officials:
References:
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