Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma
Conditions
Keywords
Hyperthermic Intraperitoneal Chemotherapy, Advanced-Stage Epithelial Ovarian Cancer, Cytoreductive surgery, Postoperative Chemotherapy
Brief summary
This project is a multi-center, prospective, randomized controlled clinical observation the safety and efficacy of hyperthermic intraperitoneal chemotherapy in the treatment of advanced-stage epithelial ovarian cancer after cytoreductive surgery. Median recurrence-free survival is the primary end points of this project.
Detailed description
The current standard treatment for epithelial ovarian cancer, tubal cancer, and primary peritoneal cancer is maximal cytoreductive surgery followed by intravenous chemotherapy with or without intraperitoneal chemotherapy (IP). Recently, the organizations of SGO and ASCO recommended that women with Fagotti score by laparoscopic exploration \< 6 would benefit from primary cytoreductive surgery followed by postoperative chemotherapy, and are likely to attain optimal cytoreduction (residual lesion ≤ 1 cm). Hyperthermia promotes chemotherapy to penetrate deeper into the cancer tissue. Therefore, hyperthermic intraperitoneal chemotherapy (HIPEC) as newly postoperative chemotherapy after primary cytoreductive surgery in the treatment of ovarian cancer could lead to higher response rate and better survival outcomes.
Interventions
PROCEDUREHyperthermic Intraperitoneal Chemotherapy
HIPEC is performed as postoperative chemotherapy after cytoreductive surgery for advanced-stage epithelial ovarian cancer. The first HIPEC is conducted within 48h after cytoreductive surgery: Paclitaxel 175 mg/m\^2, 43°C, 90min. The second HIPEC is performed after 48 hours of the first HIPEC. The HIPEC regimens are Docetaxel 75 mg/m\^2 and cisplatin 75 mg/m\^2, respectively, 43°C, 90min.
PROCEDUREcytoreductive surgery
Cytoreductive surgery (CRS) is performed when Faggoti value is less than 6 via laparoscopic exploration.
DRUGadjuvant chemotherapy
Systemic chemotherapy regimens after HIPEC treatment are paclitaxel 175 mg/m\^2 IV\>3 hour+ carboplatin AUC = 5-6 IV\>1 hour, every 3 weeks for 2 cycles in experimental group. Systemic chemotherapy regimens after IDS are paclitaxel 175 mg/m\^2 IV\>3 hour+ carboplatin AUC = 5-6 IV\>1 hour, every 3 weeks for 3 cycles in control group.
Sponsors
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Third Affiliated Hospital, Sun Yat-Sen University
Henan Provincial People's Hospital
Xiangya Hospital of Central South University
The Third Xiangya Hospital of Central South University
Peking University Cancer Hospital & Institute
Peking University People's Hospital
Cancer Hospital of Guizhou Province
Chinese PLA General Hospital
Hebei Medical University Fourth Hospital
The Second Hospital of Hebei Medical University
West China Second University Hospital
Peking Union Medical College Hospital
First Affiliated Hospital, Sun Yat-Sen University
Henan Cancer Hospital
Tianjin Medical University Cancer Institute and Hospital
The Third Affiliated Hospital of Guangzhou Medical University
Wuhan University
RenJi Hospital
Obstetrics & Gynecology Hospital of Fudan University
Southern Medical University, China
Fourth Affiliated Hospital of Guangxi Medical University
Shandong Cancer Hospital and Institute
Beijing Obstetrics and Gynecology Hospital
Chongqing University Cancer Hospital
Xinqiao Hospital of Chongqing
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
First Affiliated Hospital of Chongqing Medical University
Affiliated Cancer Hospital of Shantou University Medical College
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Disease status primary epithelial ovarian cancer, tubal cancer, and primary peritoneal cancer (Stage III ) * Fagotti score by laparoscopic exploration \< 6 * Residual tumor \< 1cm after completion of cytoreductive surgery * 18 \< Age \< 70 year old * Expected survival \> 3 months * Performance status: ECOG 0-1 * Adequate bone marrow function Hb ≥8 g/dl (After correction in case of iron deficient anemia) WBC ≥ 3,000/mm3, Platelet ≥ 100,000/mm3 * Adequate renal function Creatinine ≤ 1.5 mg/dl, and adequate hepatic function Bilirubin ≤ 1.5 mg/dl and AST and ALT ≤ 80 IU/L * Voluntary participation after getting written informed consent.
Exclusion criteria
* Fagotti score by laparoscopic exploration \>= 6 * Suboptimal debulking (residual tumor \> 1cm) * Extensive adhesion in peritoneal cavity * Previous History of other malignancies (except excision of skin cancer, thyroid cancer) * Poorly controlled disease e.g. atrial fibrillation, stenocardia, cardiac insufficiency, persistent hypertension despite medicinal treatment, ejection fraction\<50% * Receiving other chemotherapy, radiotherapy or immunotherapy * Patients who are unsuitable candidates by doctor's decision * Without given written informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Median recurrence-free survival | 3 years | assess median recurrence-free survival during 3 years in both study arms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Median overall survival | 3 years | assess median overall survival during 3 years in both study arms |
| Median progression-free survival | 3 years | assess median progression-free survival during 3 years in both study arms |
| Risk factors for morbidity and mortality | 30 days; 3 years | The early complication and mortality are defined as the event observed within 30 days after intervention, while the time frame for late complication is the period beyond 30 days after intervention to the end of 3 years. Complications are ranked from grade 0-5 according to CTCAE V4.0 |
| Quality of life for ovarian cancer | 3 years | Evaluated according to European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Ovarian Cancer Module (QLQ-OV28) |
Countries
China
Contacts
Primary ContactShuzhong Cui, M.D
Backup ContactXian-Zi Yang, M.D
Outcome results
None listed