The Efficacy of Hyperthermic Intraperitoneal Chemotherapy to Ovarian Cancer Patients With Homologous Recombination Repair Defect and Residual: a Prospective Cohort Study

Ovarian Cancer Clinical Trial

Official title:

The Efficacy of Hyperthermic Intraperitoneal Chemotherapy to Ovarian Cancer Patients With Homologous Recombination Repair Defect and Residual: a Prospective Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05265117
• Other study ID #: 2021-KY-073
• Status: Recruiting
• Start date: April 1, 2022
• Est. completion date: March 30, 2025

Study information

• Verified date: February 2022
• Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Contact: Miao Fang Wu
• Phone: 13828494674
• Email: rich192468[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Ovarian cancer is associated with the highest mortality of all gynecologic cancers. In patients with newly diagnosed advanced ovarian cancer after platinum-containing chemotherapy plus bevacizumab therapy, maintenance therapy with olaparib plus bevacizumab significantly prolongs progression-free survival (PFS) in the intended population and is recommended by guidelines. However, study shows those homologous recombinant repair defect (HRD) but Breast Cancer Susceptibility Gene(BRCA) wild type have limited benefit from maintenance therapy with olaparib plus bevacizumab when surgery is with residual(no-R0).

Can hyperthermic intraperitoneal chemotherapy(HIPEC) improve the benefits of first-line maintenance therapy in patients with non-R0 resection, HRD? The cohort study will enroll 310 patients with HRD and no-R0 resection who conduct HIPEC during primary treatment and then have olaparib plus bevacizumab as maintenance. Follow-up period is 30 months. The primary endpoint is PFS.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 310
• Est. completion date: March 30, 2025
• Est. primary completion date: March 30, 2025
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Age 18-70 years

• Eastern Cooperative Oncology Group (ECOG) score 0-1

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

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

• 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

• surgery with residual

• eligible to the maintenance therapy of olaparib plus bevacizumab

Exclusion Criteria:

• Expected life span =8 weeks

• Complicated with any other known malignancies

• Patients with dysfunction of swallow and digestion

• Patients who had received any kind of poly adenosinediphosphate-ribose polymerase(PARP)inhibitor

• refractory hypertension

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Procedure:
• HIPEC
HIPEC is given after primary or interval debulking surgery.

Locations

Country	Name	City	State
China	Sun Yat-sen Memorial Hospital, Sun Yat-sen University	Guangzhou	Guangdong

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	PFS		from the date of recruitment to the time of recurrence, assessed up to 30 months
Secondary	overall survival		from the date of recruitment to the time of death from any cause, assessed up to 30 months
Secondary	adverse effect		from the date of recruitment up to 30 months