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

CAI Hongbing

Status and phase: Unknown; Phase 3

Conditions: Epithelial Ovarian Cancer; Ovarian Cancer, Epithelial; Hyperthermic Intraperitoneal Chemotherapy(HIPEC); Ovarian Cancer; Homologous Recombination Repair Gene Mutation

Treatments: Procedure: CRS alone; Procedure: CRS+HIPEC

Study type: Interventional

Funder types: Other

Identifiers

NCT04473339

2020107

Details and patient eligibility

About

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.

Enrollment: 280 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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280 participants in 4 patient groups

HRR mt 1

Experimental group

Description:

Patients are HRR mutated type, will undergo CRS plus HIPEC and then go on to receive standard platinum-based combination doublet intravenous chemotherapy.

Treatment:

Procedure: CRS+HIPEC

HRR mt 2

Experimental group

Description:

Patients are HRR mutated type, will undergo CRS and then go on to receive standard platinum-based combination doublet intravenous chemotherapy.

Treatment:

Procedure: CRS alone

HRR wt 3

Experimental group

Description:

Patients are HRR wild type, will undergo CRS plus HIPEC and then go on to receive standard platinum-based combination doublet intravenous chemotherapy.

Treatment:

Procedure: CRS+HIPEC

HRR wt 4

Experimental group

Description:

Patients are HRR wild type, will undergo CRS and then go on to receive standard platinum-based combination doublet intravenous chemotherapy.

Treatment:

Procedure: CRS alone