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Trial Title:
Administration of Hyperthermic Intraperitoneal Chemotherapy in the General Ward
NCT ID:
NCT06277947
Condition:
Epithelial Ovarian Cancer
Conditions: Official terms:
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Hyperthermia
Fever
Conditions: Keywords:
Epithelial Ovarian Cancer
Hyperthermic Intraperitoneal Chemotherapy
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Patients would receive C-HIPEC in the general ward after interval debulking surgery in 24
hours.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
China Hyperthermic Intraperitoneal Chemotherapy(C-HIPEC)
Description:
The C-HIPEC would be performed at bedside in the general ward within 24 hours after
surgery. The HIPEC treatment instruments are BR-TRG-II system, which can control the
temperature stably to 43℃±0.1℃.
Arm group label:
C-HIPEC arm
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.
Criteria for 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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Address:
City:
Guangzhou
Country:
China
Start date:
February 2024
Completion date:
May 2025
Lead sponsor:
Agency:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Agency class:
Other
Collaborator:
Agency:
Shenshan Medical Center, Memorial Hospital of Sun Yat-sen University
Agency class:
Other
Source:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06277947
