Clinical trial NCT05265117: The Efficacy of Hyperthermic Intraperitoneal Chemotherapy to Ovarian Cancer Patients With Homologous Recombination Repair Defect and Residual: a Prospective Cohort Study
Official title: The Efficacy of Hyperthermic Intraperitoneal Chemotherapy to Ovarian Cancer Patients With Homologous Recombination Repair Defect and Residual: a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ovarian Cancer
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2022-03-03
Enrollment: 310
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: high-grade serous ovarian cancer, International Federation of Gynecology and Obstetrics stage III-IV,HRD but BRCA wild type, chemotherapy regimen contains platinum and bevacizumab and then olaparib plus bevacizumab will be given as the maintenance therapy.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: PFS
timeFrame: from the date of recruitment to the time of recurrence, assessed up to 30 months
Secondary outcomes:
measure: overall survival
timeFrame: from the date of recruitment to the time of death from any cause, assessed up to 30 months
measure: adverse effect
timeFrame: from the date of recruitment up to 30 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University
state: Guangdong
Study officials:
References: