A Randomized Prospective Trail of HIPEC in Recurrent Ovarian Cancer Patients With HRR Mutation

Phase 3

• Conditions: Ovarian Cancer, Epithelial; Hyperthermic Intraperitoneal Chemotherapy(HIPEC); Epithelial Ovarian Cancer; Ovarian Cancer; Homologous Recombination Repair Gene Mutation
• Interventions: Procedure: CRS+HIPEC; Procedure: CRS alone

• Registration Number: NCT04473339
• Lead Sponsor: CAI Hongbing

Brief Summary

A phase III prospective study with the primary objective to investigate the benefit of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in ovarian cancer patients with mutations in homologous recombination repair (HRR) genes. The target population for this study is patients with recurrent ovarian, peritoneal or fallopian tube cancers undergoing Cytoreductive Surgery (CRS). Patients will be divided into two groups according to HRR genes mutation, each group will be further divided into two sub-groups with different intervention. Patients in Group A are HRR mutated type, sub-group 1 will undergo CRS plus HIPEC and then go on to receive standard platinum-based combination doublet intravenous chemotherapy, sub-group 2 will undergo CRS and then go on to intravenous chemotherapy. Patients in Group B are HRR wild type, sub-group 3 will undergo CRS plus HIPEC and then go on to receive standard platinum-based combination doublet intravenous chemotherapy, sub-group 4 will undergo CRS and then go on to intravenous chemotherapy. All patients will receive maintenance therapy with Niraparib after primary treatment. Prognostic information will be collected for investigation of survival benefits of patients.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-07
• Study First Submitted: 2020-07-12
• Study First Submitted QC: 2020-07-15
• Study First Posted: 2020-07-16
• Study Start: 2020-08-01
• Last Update Submitted: 2020-09-04
• Last Update Posted: 2020-09-09
• Primary Completion: 2023-08-30
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 280

Inclusion Criteria

• age 18-75
• Karnofsky performance status >50 or World Health Organization performance score < 2
• primary or recurrence ovarian, peritoneal or fallopian tube epithelial cancer; first intra-abdominal recurrence without distant metastasis (including: unique resectable pleural metastasis which are platinum-sensitive; resectable single lymphatic metastasis retroperitoneal or inguinal)
• preoperative platinum-based chemotherapy (carboplatin and paclitaxel, carboplatin and liposomal doxorubicin, gemcitabine, trabectedin or topotecan)
• lesion can be removed completely or residual disease < 0.5 cm
• last chemotherapy finished no more than 12 weeks after surgery
• no hepatic function damage
• white blood cell count ≥3.5*10^9/L; platelet count ≥80*10^9/L; Hemoglobin ≥90g/L
• no contraindication of surgery and anesthesia
• life expectancy ≥ 3 months
• informed consent form signed

Exclusion Criteria

• age < 18 or >75
• no history of other cancer
• platinum allergy
• distant metastasis
• used anti-angiogenic drug within 8 weeks
• possibility of more than two resection of alimentary canal
• recurrence < 6 months after primary treatment
• histologic type: non epithelial origin
• infection out of control
• follow-up unable to carry on (geographic or psychic)
• cardiac insufficiency or respiratory insufficiency
• has received HIPEC already
• being in other clinical study
• pregnancy or lactation period

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HRR wt 3	CRS+HIPEC	Patients are HRR wild type, will undergo CRS plus HIPEC and then go on to receive standard platinum-based combination doublet intravenous chemotherapy.
HRR wt 4	CRS alone	Patients are HRR wild type, will undergo CRS and then go on to receive standard platinum-based combination doublet intravenous chemotherapy.
HRR mt 2	CRS alone	Patients are HRR mutated type, will undergo CRS and then go on to receive standard platinum-based combination doublet intravenous chemotherapy.
HRR mt 1	CRS+HIPEC	Patients are HRR mutated type, will undergo CRS plus HIPEC and then go on to receive standard platinum-based combination doublet intravenous chemotherapy.

Primary Outcome Measures

Name	Time	Method
Progression-free Survival	up to 36 months since diagnosis	The progression-free survival interval was the time between diagnosis and evidence of recurrent or progressive disease.

Secondary Outcome Measures

Name	Time	Method
Overall Survival	up to 36 months since histological diagnosis	The overall survival interval was the time between diagnosis and death or last follow-up.
DP12	the 1 day of histological diagnosis and 12 months after	The 9 months progression-free survival rate was the rate of no evidence of recurrent or progressive disease at the time of 12 months since histological diagnosis.
DP9	the 1 day of histological diagnosis and 9 months after	The 9 months progression-free survival rate was the rate of no evidence of recurrent or progressive disease at the time of 9 months since histological diagnosis.
Serious adverse events, SAEs	surgery and with in 30 days	Serious adverse events occur within 30 days after surgery, measured with CTCAE 4.0

Trial Locations

Locations (1)

Zhongnan Hospital of Wuhan University; 🇨🇳 Wuhan, Hubei, China