Administration of Hyperthermic Intraperitoneal Chemotherapy in the General Ward

Epithelial Ovarian Cancer Clinical Trial

— GARD-HIPEC  

Official title:

Administration of Hyperthermic Intraperitoneal Chemotherapy in the General Ward: a Multicenter, Prospective, Feasibility Study (GARD-HIPEC Study)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06277947
• Other study ID #: SYSKY-2024-096-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 2024
• Est. completion date: May 2025

Study information

• Verified date: February 2024
• Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Contact: Jing Li, Doctor
• Phone: 15915893493
• Email: lijing228[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 92
• Est. completion date: May 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Epithelial Ovarian Cancer
• Fever
• Hyperthermia
• Ovarian Neoplasms

Intervention

Procedure:
• China Hyperthermic Intraperitoneal Chemotherapy(C-HIPEC)
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?.

Locations

Country	Name	City	State
China	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University	Guangzhou

Sponsors (2)

Lead Sponsor	Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University	Shenshan Medical Center, Memorial Hospital of Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (11)

Arjona-Sanchez A, Espinosa-Redondo E, Gutierrez-Calvo A, Segura-Sampedro JJ, Perez-Viejo E, Concepcion-Martin V, Sanchez-Garcia S, Garcia-Fadrique A, Prieto-Nieto I, Barrios-Sanchez P, Torres-Melero J, Ramirez Faraco M, Prada-Villaverde A, Carrasco-Campos — View Citation

Aronson SL, Lopez-Yurda M, Koole SN, Schagen van Leeuwen JH, Schreuder HWR, Hermans RHM, de Hingh IHJT, van Gent MDJM, Arts HJG, van Ham MAPC, van Dam PA, Vuylsteke P, Aalbers AGJ, Verwaal VJ, Van de Vijver KK, Aaronson NK, Sonke GS, van Driel WJ. Cytored — View Citation

Chambers LM, Costales AB, Crean-Tate K, Kuznicki M, Morton M, Horowitz M, Jagielo T, Rose PG, Michener C, Vargas R, Debernardo R. A guide to establishing a hyperthermic intraperitoneal chemotherapy program in gynecologic oncology. Gynecol Oncol. 2020 Sep;158(3):794-802. doi: 10.1016/j.ygyno.2020.06.487. Epub 2020 Jul 2. — View Citation

Chan CY, Li H, Wu MF, Liu CH, Lu HW, Lin ZQ, Li J. A Dose-Finding Trial for Hyperthermic Intraperitoneal Cisplatin in Gynecological Cancer Patients Receiving Hyperthermic Intraperitoneal Chemotherapy. Front Oncol. 2021 Mar 11;11:616264. doi: 10.3389/fonc. — View Citation

Ledermann JA, Raja FA, Fotopoulou C, Gonzalez-Martin A, Colombo N, Sessa C; ESMO Guidelines Working Group. Newly diagnosed and relapsed epithelial ovarian carcinoma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2013 Oct;24 Suppl 6:vi24-32. doi: 10.1093/annonc/mdt333. No abstract available. Erratum In: Ann Oncol. 2018 Oct 1;29(Suppl 4):iv259. — View Citation

Lee JY, Lee YJ, Son JH, Kim S, Choi MC, Suh DH, Song JY, Hong DG, Kim MK, Kim JH, Chang SJ. Hyperthermic Intraperitoneal Chemotherapy After Interval Cytoreductive Surgery for Patients With Advanced-Stage Ovarian Cancer Who Had Received Neoadjuvant Chemoth — View Citation

Lemoine L, Sugarbaker P, Van der Speeten K. Drugs, doses, and durations of intraperitoneal chemotherapy: standardising HIPEC and EPIC for colorectal, appendiceal, gastric, ovarian peritoneal surface malignancies and peritoneal mesothelioma. Int J Hyperthermia. 2017 Aug;33(5):582-592. doi: 10.1080/02656736.2017.1291999. — View Citation

Lim MC, Chang SJ, Park B, Yoo HJ, Yoo CW, Nam BH, Park SY; HIPEC for Ovarian Cancer Collaborators. Survival After Hyperthermic Intraperitoneal Chemotherapy and Primary or Interval Cytoreductive Surgery in Ovarian Cancer: A Randomized Clinical Trial. JAMA — View Citation

Sin EI, Chia CS, Tan GHC, Soo KC, Teo MC. Acute kidney injury in ovarian cancer patients undergoing cytoreductive surgery and hyperthermic intra-peritoneal chemotherapy. Int J Hyperthermia. 2017 Sep;33(6):690-695. doi: 10.1080/02656736.2017.1293304. Epub 2017 Mar 5. — View Citation

Wu MF, Cheng XY, Wang DY, Lai YT, Li H, Ye YF, Peng YP, Chen Q, Zhang BZ, Lin ZQ, Li J. Determining the maximum tolerated dose of paclitaxel combined with fixed dose of cisplatin for hyperthermic intraperitoneal chemotherapy in ovarian cancer: A multicenter phase I trial. Gynecol Oncol. 2024 Feb;181:125-132. doi: 10.1016/j.ygyno.2023.12.019. Epub 2023 Dec 30. — View Citation

You ZY, Wu MF, Li H, Ye YF, Wang LJ, Lin ZQ, Li J. A phase I dose-finding trial of hyperthermic intraperitoneal docetaxel combined with cisplatin in patients with advanced-stage ovarian cancer. J Gynecol Oncol. 2024 Jan;35(1):e1. doi: 10.3802/jgo.2024.35. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of adverse events of grade 3-5	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.	up to 3 weeks after C-HIPEC.
Secondary	Time to progress (TTP)	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.	from the end of IV chemotherapy to 1 year after C-HIPEC or relapse
Secondary	The Time to the First Subsequent Therapy,TTFST	The Time to the First Subsequent Therapy	C-HIPEC to the first subsequent IV chemotherapy
Secondary	Quality of life, QLQ-C30	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).	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)