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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Ovarian Cancer, Ovary Neoplasm, Ovarian Neoplasms, Epithelial Ovarian Cancer, Ovarian Cancer, Epithelial, Hyperthermic Intraperitoneal Chemotherapy(HIPEC)

Intervention / Treatment
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* Device: HIPEC
* Device: CRS
* Device: IVCT


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HIPEC<br>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. | Device: HIPEC<br>* 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.<br>Device: CRS<br>* cytoreductive surgery (CRS) to a residual disease ≤ 2.5 mm.<br>Device: IVCT<br>* platinum-based intravenous chemotherapy<br>|
| Other: Non HIPEC<br>Patients will undergo only CRS and IVCT. Patients will receive standard platinum-based combination doublet chemotherapy for 6-8 cycles after CRS. | Device: CRS<br>* cytoreductive surgery (CRS) to a residual disease ≤ 2.5 mm.<br>Device: IVCT<br>* platinum-based intravenous chemotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival rate | assess overall survival rate in 5 years in both arms | 5 years | 
| 1 year survival rate | assess the survival rate in 1 year for both arms | 1 year | 
| 3 year survival rate | assess the survival rate in 3 years for both arms | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival | assess the Progression-free survival rate during 5 years for both study arms | 5 years | 
| quality of life | Patients will fill the EORTC Quality of life questionaire-C30 form to measure the quality of life after a standard treatment. | 5 years after CRS or until death | 
| postoperative complication | measured with physical examination and/or computed tomography（CT）and/or ultrasound examination. | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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epithelial ovarian cancer, hyperthermic intraperitoneal chemotherapy