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All Conditions

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Genital Diseases

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Female Urogenital Diseases and Pregnancy Complications

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Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

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Heat Stress Disorders

Ovarian Cancer

Ovarian Epithelial Cancer

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

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

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

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

Patients will undergo only CRS, HIPEC and IVCT.Patients will receive standard platinum-based combination doublet chemotherapy for 6-8 cycles after CRS and then followed by maintenance therapy.

A single drug lobaplatin(30mg/m2)will be administered in normal saline via HIPEC and it will be continued for 60 minutes in the hyperthermic phase (41°C-43°C). HIPEC will be performed at the 1st, 3rd and 5th day after CRS. The intravenous chemotherapy(IVCT) will start from 7th-14th day after CRS.

CRS+HIPEC

Patients will undergo only CRS and IVCT.Patients will receive standard platinum-based combination doublet chemotherapy for 6-8 cycles after CRS and then followed by maintenance therapy.

CRS alone

Hongbing Cai, Doctor

Zhen Li, Doctor

Yuanzhen Zhang, Doctor

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.

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

A Randomized Prospective Trail of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Recurrent Ovarian Cancer Patients With Mutations in Homologous Recombination Repair (HRR) Genes

The progression-free survival interval was the time between diagnosis and evidence of recurrent or progressive disease.

The overall survival interval was the time between diagnosis and death or last follow-up.

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.

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.

Serious adverse events occur within 30 days after surgery, measured with CTCAE 4.0

CAI Hongbing

Dr. Prof.

Pharmaceutical Solutions

All Drugs and Chemicals

Patients will undergo a CRS plus HIPEC and IVCT. Hyperthermic intraperitoneal chemotherapy (HIPEC) is a procedure in which the abdominal cavity is bathed in a warm solution of anti-cancer medications for 60 minutes.

A single drug lobaplatin(30mg/m2)will be administered in normal saline via HIPEC and it will be continued for 60 minutes in the hyperthermic phase (41°C-43°C). HIPEC will be performed at the 1st, 3rd and 5th day after CRS. The intravenous chemotherapy(IVCT) will start from 7th-14th day after CRS.

Patients will undergo only CRS and IVCT. Patients will receive standard platinum-based combination doublet chemotherapy for 6-8 cycles after CRS.

Patients consenting to this protocol will undergo their scheduled surgical procedure. After cytoreductive surgery (CRS) to a residual disease ≤ 2.5 mm, a single dose of lobaplatin (30 mg/m2) will be administered in normal saline via intraperitoneal hyperthermic perfusion using the closed-abdomen technique. HIPEC will be continued for 60 minutes in the hyperthermic phase (43℃±0.5℃). And HIPEC will be repeated at the 3 and 5 day after the day of CRS plus HIPEC.

HIPEC

cytoreductive surgery (CRS) to a residual disease ≤ 2.5 mm.

IVCT

A phase III prospective study with the primary objective to compare the efficacy and safety of HIPEC( Hyperthermic Intraperitoneal Chemotherapy). The target population for this study is patients with primary or recurrence ovarian, peritoneal or fallopian tube cancers undergoing CRS( Cytoreductive Surgery). Patients will be divided into two groups. Group A will undergo CRS plus HIPEC and then go on to receive standard platinum-based combination doublet intravenous chemotherapy. Group B will undergo CRS and then go on to intravenous chemotherapy.

This is a phase III prospective study with the primary objective to compare the efficacy and safety of HIPEC. The target population for this study is patients with primary or recurrence ovarian, peritoneal or fallopian tube cancers undergoing CRS. 'Platinum-sensitive' recurrence is defined as recurrence 6 months after the completion of the primary platinum-based chemotherapy. A single dose of lobaplatin 40mg/m2 will be administered via HIPEC , and will be administered at the time of surgery, 3 days after surgery and 5 days after surgery. Patients of group A will undergo CRS plus HIPEC and then go on to receive standard platinum-based combination doublet intravenous chemotherapy (carboplatin and paclitaxel, carboplatin and gemcitabine, or carboplatin and liposomal doxorubicin) for 6 cycles. Patients of group B will undergo CRS and then go on to intravenous chemotherapy.

Cytoreductive Surgery(CRS) Plus Hyperthermic Intraperitoneal Chemotherapy(HIPEC) With Lobaplatin in Advanced and Recurrent Epithelial Ovarian Cancer

A Phase III Clinical Trail of Cytoreductive Surgery(CRS) Plus Hyperthermic Intraperitoneal Chemotherapy(HIPEC) With Lobaplatin in Advanced and Recurrent Epithelial Ovarian Cancer

assess overall survival rate in 5 years in both arms

assess the survival rate in 1 year for both arms

assess the survival rate in 3 years for both arms

assess the Progression-free survival rate during 5 years for both study arms

Patients will fill the EORTC Quality of life questionaire-C30 form to measure the quality of life after a standard treatment.

measured with physical examination and/or computed tomography（CT）and/or ultrasound examination.

Zhongnan Hospital

Professor of Wuhan University, MD, PhD, Chef of the Department of Gynecological Oncology of Zhongnan Hospital, member of the standing committee of Chinese Gynecologic Cancer Society

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Randomized Prospective Trail of HIPEC in Recurrent Ovarian Cancer Patients With HRR Mutation	NCT04473339	Ovarian Cancer Epithelial Ovar... Ovarian Cancer,... Hyperthermic In... Homologous Reco...	CRS+HIPEC CRS alone	18 Years - 75 Years	Zhongnan Hospital
A Randomized Prospective Trail of HIPEC in Recurrent Ovarian Cancer Patients With HRR Mutation	NCT04473339	Ovarian Cancer Epithelial Ovar... Ovarian Cancer,... Hyperthermic In... Homologous Reco...	CRS+HIPEC CRS alone	18 Years - 75 Years	Zhongnan Hospital
Cytoreductive Surgery(CRS) Plus Hyperthermic Intraperitoneal Chemotherapy(HIPEC) With Lobaplatin in Advanced and Recurrent Epithelial Ovarian Cancer	NCT03371693	Ovarian Cancer Ovary Neoplasm Ovarian Neoplas... Epithelial Ovar... Ovarian Cancer,... Hyperthermic In...	HIPEC CRS IVCT	18 Years - 75 Years	Zhongnan Hospital
A Randomized Prospective Trail of HIPEC in Recurrent Ovarian Cancer Patients With HRR Mutation	NCT04473339	Ovarian Cancer Epithelial Ovar... Ovarian Cancer,... Hyperthermic In... Homologous Reco...	CRS+HIPEC CRS alone	18 Years - 75 Years	Zhongnan Hospital

Spots Global Cancer Trial Database for hyperthermic intraperitoneal chemotherapy(hipec)