NCT05265117

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
310

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 2, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 3, 2022

Completed
29 days until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2025

Completed
Last Updated

February 17, 2023

Status Verified

February 1, 2022

Enrollment Period

3 years

First QC Date

March 2, 2022

Last Update Submit

February 16, 2023

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

  • PFS

    from the date of recruitment to the time of recurrence, assessed up to 30 months

Secondary Outcomes (2)

  • overall survival

    from the date of recruitment to the time of death from any cause, assessed up to 30 months

  • adverse effect

    from the date of recruitment up to 30 months

Study Arms (2)

HIPEC

HIPEC is given after primary debulking surgery or interval debulking.

Procedure: HIPEC

CONTROL

No HIPEC

Interventions

HIPECPROCEDURE

HIPEC is given after primary or interval debulking surgery.

HIPEC

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Hyperthermic Intraperitoneal Chemotherapy

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Intervention Hierarchy (Ancestors)

Chemotherapy, AdjuvantCombined Modality TherapyTherapeuticsDrug TherapyHyperthermia, Induced

Central Study Contacts

Miao Fang Wu

CONTACT

13828494674rich192468@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2022

First Posted

March 3, 2022

Study Start

April 1, 2022

Primary Completion

March 30, 2025

Study Completion

March 30, 2025

Last Updated

February 17, 2023

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)