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| Name | Class |
|---|---|
| Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | OTHER |
| Third Affiliated Hospital, Sun Yat-Sen University | OTHER |
| Henan Provincial People's Hospital | OTHER |
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This project is a multi-center, prospective, randomized controlled clinical observation the safety and efficacy of hyperthermic intraperitoneal chemotherapy as neoadjuvant chemotherapy(NACT) and postoperative chemotherapy after interval debulking surgery (IDS) for advanced-stage epithelial ovarian cancer . PR/SD rate, percentage of optimal debulking surgery and 3-year disease-free survival is the primary end points of this project.
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 a high perioperative risk profile or a low likelihood of achieving cytoreduction to < 1 cm of residual disease (ideally to novisible disease) should receive neoadjuvant chemotherapy.
Hyperthermia promotes chemotherapy to penetrate deeper into the cancer tissue. Therefore, hyperthermic intraperitoneal chemotherapy (HIPEC) as neoadjuvant chemotherapy and postoperative chemotherapy after interval debulking surgery in the treatment of ovarian cancer could lead to higher response rate and better survival outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental |
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| Control group | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyperthermic Intraperitoneal Chemotherapy | Procedure | HIPEC is performed as neoadjuvant chemotherapy(NACT) and postoperative chemotherapy after interval debulking surgery (IDS) for advanced-stage epithelial ovarian cancer. The first HIPEC is conducted within 24h after laparoscopic exploration or Interval debulking surgery: Paclitaxel 175 mg/m^2, 43°C, 90min. The second HIPEC is performed after 48 hours of the first HIPEC. The second HIPEC regimens are cisplatin 75 mg/m^2, 43°C, 90min. |
| Measure | Description | Time Frame |
|---|---|---|
| PR/SD rate | calculate the percent of partial remission (PR) plus stable disease (SD) of patients received HIPEC+NACT or NACT alone in both two arms | Through study completion, an average of 1 year |
| Percentage of optimal debulking surgery | evaluate the percentage of optimal debulk (residual disease < 1cm) after interval debulking surgery between study arms | Through study completion, an average of 1 year |
| Disease-free survival rate | assess disease free survival rate during 3 years in both study arms | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival rate | assess overall survival rate during 3 years in both study arms | 3 years |
| Risk factors for morbidity and mortality | determine percent of patients wtih Grade I-IV adverse events according to NCI criteria, Common Terminology Criteria for AE (CTCAE 4.0). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shuzhong Cui, M.D | Contact | 0086-138-0251-3800 | cuishuzhong@126.com | |
| Xianzi Yang, M.D | Contact | 0086-188-9853-4167 | 7097359@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Shuzhong Cui, M.D | Affiliated Cancer Hospital & Institute of Guangzhou Medical University | Study Director |
| Zhongqiu Lin, M.D | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Abdominal Surgery (Section 2), Affiliated Tumor Hospital of Guangzhou Medical University | Guangzhou | Guangdong | 510095 | China |
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| Xiangya Hospital of Central South University |
| OTHER |
| The Third Xiangya Hospital of Central South University | OTHER |
| Peking University Cancer Hospital & Institute | OTHER |
| Peking University People's Hospital | OTHER |
| Cancer Hospital of Guizhou Province | OTHER |
| Chinese PLA General Hospital | OTHER |
| Hebei Medical University Fourth Hospital | OTHER |
| The Second Hospital of Hebei Medical University | OTHER |
| West China Second University Hospital | OTHER |
| Peking Union Medical College Hospital | OTHER |
| First Affiliated Hospital, Sun Yat-Sen University | OTHER |
| Henan Cancer Hospital | OTHER_GOV |
| Tianjin Medical University Cancer Institute and Hospital | OTHER |
| The Third Affiliated Hospital of Guangzhou Medical University | OTHER |
| Wuhan University | OTHER |
| RenJi Hospital | OTHER |
| Obstetrics & Gynecology Hospital of Fudan University | OTHER |
| Southern Medical University, China | OTHER |
| Fourth Affiliated Hospital of Guangxi Medical University | OTHER |
| Shandong Cancer Hospital and Institute | OTHER |
| Beijing Obstetrics and Gynecology Hospital | OTHER |
| Chongqing Cancer Institute | UNKNOWN |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | OTHER |
| Xinqiao Hospital of Chongqing | OTHER |
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| Interval debulking surgery | Procedure | Cytoreductive surgery (CRS) is performed after neoadjuvant chemotherapy. |
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| neoadjuvant chemotherapy | Drug | 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 laparoscopic exploration 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. |
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| adjuvant chemotherapy | Drug | 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. |
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| Through study completion, an average of 1 year |
| Quality of life | Evaluated according to European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Cancer (EORTC QLQ-C30) | 3 years |
| Quality of life for ovarian cancer | Evaluated according to European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Ovarian Cancer Module (QLQ-OV28) | 3 years |
| ID | Term |
|---|---|
| D000077216 | Carcinoma, Ovarian Epithelial |
| D005185 | Fallopian Tube Neoplasms |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D010051 | Ovarian Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D005184 | Fallopian Tube Diseases |
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| ID | Term |
|---|---|
| D000084262 | Hyperthermic Intraperitoneal Chemotherapy |
| D020360 | Neoadjuvant Therapy |
| D017024 | Chemotherapy, Adjuvant |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D006979 | Hyperthermia, Induced |
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