Efficacy of Neoadjuvant Hyperthermic Intraperitoneal Chemotherapy in Advanced High-grade Serous Ovarian Cancer (the NHIPEC Trial)

Neoadjuvant Chemotherapy Clinical Trial

— NHIPEC  

Official title:

Efficacy of Neoadjuvant Hyperthermic Intraperitoneal Chemotherapy in Advanced High-grade Serous Ovarian Cancer (the NHIPEC Trial)：a Randomised Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05246020
• Other study ID #: 2020-KY-050
• Status: Recruiting
• Phase: Phase 2
• Start date: December 1, 2020
• Est. completion date: December 1, 2024

Study information

• Verified date: January 2022
• Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Contact: miaofang Wu, Doctor
• Phone: +8613828494674
• Email: wmiaofang[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Background: Neoadjuvant chemotherapy (NACT) is an important treatment option for patients with ovarian cancer. Although intravenous NACT can improve optimal resection rates and decrease surgical morbidity and mortality, these advantages do not translate into a survival benefit. Ovarian carcinoma is mainly confined to the peritoneal cavity, which makes it a potential target for hyperthermic intraperitoneal chemotherapy (HIPEC). Our previous study showed that HIPEC could be used in the neoadjuvant setting, which was named neoadjuvant HIPEC (NHIPEC). Since hyperthermia is an excellent chemosensitiser, we hypothesised that the combination of NHIPEC and intravenous NACT could show superior efficacy to intravenous NACT alone. Methods: This study is a single-centre, open-label, randomised (1:1 allocation ratio) phase 2 trial. A total of 80 patients will be randomly assigned into an experimental group (NHIPEC+intravenous NACT) or a control group (intravenous NACT). Patients in the experimental group will receive NHIPEC following laparoscopic evaluation, and four tubes will be placed via the laparoscopic ports, which will be used to administer NHIPEC. Then, perfusion with docetaxel (60-75 mg/m2) will be performed (43°C for 60 min, Day 0) followed by cisplatin (75 mg/m2, Day 1) infusion (43°C for 60 min) 24 hours later. After NHIPEC, two cycles of intravenous NACT will be given. Patients in the control group will receive three cycles of intravenous NACT. The primary endpoint is the proportion of patients who achieve a Chemotherapy Response Score (CRS) of 3 according to the CRS system. The secondary endpoints include progression-free survival, overall survival and the rates of complete resection and NHIPEC-related adverse events.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 17 Years to 70 Years

Eligibility

Inclusion Criteria:

1. International Federation of Gynecology and Obstetrics(FIGO) stage IIIC-IVA, HGSOC

2. Patients with Fagotti score =8

3. Adequate kidney function (blood creatinine 58-96 µmol/L)

4. Adequate haematological function (haemoglobin =110g/L, leucocytes =4.0×109/L, neutrophils =2.0×109/L, platelets=100×109/L)

5. Adequate liver function (serum total bilirubin 3.4-22.2µmol/L, alanine aminotransferase (ALT) 7-40U/L, aspartate aminotransferase (AST) 13-35U/L, AST/ALT =1.5)

6. World Health Organization(WHO) score 0-2

Exclusion Criteria:

1. Patients who had received chemotherapy, radiotherapy or any kind of targeted therapy.

2. Patients with complete intestine obstruction.

3. Expected life span =8 weeks.

4. Complicated with any other known malignancies.

5. Patients with poor cardiopulmonary function, which would limit compliance with study requirements.

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Fever
• Hyperthermia
• Hyperthermic Intraperitoneal Chemotherapy
• Neoadjuvant Chemotherapy
• Ovarian Neoplasms

Intervention

Procedure:
• HIPEC
Docetaxel (60-75mg/m2) perfusion solution will be infused into the peritoneal cavity through the tubes within 24 hours after the laparoscopic evaluation. Then, perfusate containing cisplatin (75 mg/m2) will be infused 24 hours later. NHIPEC will be administered at 43°C for a duration of 60min. Saline solution (3000mL) will be used to dissolve the drug, and it will be heated and circulated at a flow rate of 300-500 mL/min.
• intravenous chemotherapy
Patients in the control group will receive three cycles of intravenous NACT. The regimen of intravenous NACT is docetaxel 60-75mg/m2 followed by carboplatin AUC 5 for a 21-day cycle.

Locations

Country	Name	City	State
China	Sun Yat-sen Memorial Hospital	Guangzhou	Other (Non U.s.)

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	chemotherapy response score(CRS) 3	the proportion of chemotherapy response score 3, which means a better outcome	At the end of cycle 3 NACT (each cycle is 21 days)
Secondary	progression-free survival(PFS)	progression-free survival	From date of randomization until the date of first documented progression, assessed up to 3 years
Secondary	overall survival(OS)	overall survival	From date of randomization until the time of death from any cause, assessed up to 3 years
Secondary	Rate of R0 resection	the R0 resection rate of interval debulking surgery(IDS)	At the end of cycle 3 NACT (each cycle is 21 days),when IDS is conducted
Secondary	NHIPEC-related adverse effects	the adverse effects of NHIPEC	during the procedure