Efficacy of neoadjuvant hyperthermic intraperitoneal chemotherapy in advanced high-grade serous ovarian cancer (the NHIPEC trial): study protocol for a randomised controlled trial
Background Neoadjuvant chemotherapy (NACT) is an important treatment option for patients with ovarian cancer. Although intravenous NACT can improve optimal resection rates and decrease surgical morbidity and mortality, these advantages do not translate into a survival benefit. Ovarian carcinoma is m...
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2021-12-01
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| author | Hui Zhou Jing Li Qing Chen Ji-Bin Li Li-juan Wang Yan-Fang Ye Miao-Fang Wu Chang-Hao Liu Huai-Wu Lu Ting-Ting Yao Bing-Zhong Zhang Yong-Pai Peng Zhong-Qiu Lin |
| author_facet | Hui Zhou Jing Li Qing Chen Ji-Bin Li Li-juan Wang Yan-Fang Ye Miao-Fang Wu Chang-Hao Liu Huai-Wu Lu Ting-Ting Yao Bing-Zhong Zhang Yong-Pai Peng Zhong-Qiu Lin |
| author_sort | Hui Zhou |
| collection | DOAJ |
| description | Background Neoadjuvant chemotherapy (NACT) is an important treatment option for patients with ovarian cancer. Although intravenous NACT can improve optimal resection rates and decrease surgical morbidity and mortality, these advantages do not translate into a survival benefit. Ovarian carcinoma is mainly confined to the peritoneal cavity, which makes it a potential target for hyperthermic intraperitoneal chemotherapy (HIPEC). Our previous study showed that HIPEC could be used in the neoadjuvant setting, which was named neoadjuvant HIPEC (NHIPEC). Since hyperthermia is an excellent chemosensitiser, we hypothesised that the combination of NHIPEC and intravenous NACT could show superior efficacy to intravenous NACT alone.Methods This study is a single-centre, open-label, randomised (1:1 allocation ratio) phase 2 trial. A total of 80 patients will be randomly assigned into an experimental group (NHIPEC+intravenous NACT) or a control group (intravenous NACT). Patients in the experimental group will receive NHIPEC following laparoscopic evaluation, and four tubes will be placed via the laparoscopic ports, which will be used to administer NHIPEC. Then, perfusion with docetaxel (60–75 mg/m2) will be performed (43°C for 60 min, Day 0) followed by cisplatin (75 mg/m2, Day 1) infusion (43°C for 60 min) 24 hours later. After NHIPEC, two cycles of intravenous NACT will be given. Patients in the control group will receive three cycles of intravenous NACT. The primary endpoint is the proportion of patients who achieve a Chemotherapy Response Score (CRS) of 3 according to the CRS system. The secondary endpoints include progression-free survival, overall survival and the rates of complete resection and NHIPEC-related adverse events.Ethics approval and dissemination This study was approved by the Ethics Committee of Sun Yat-sen Memorial Hospital (approval number: 2020-ky-050). Results will be submitted to peer-reviewed journals and presented at national and international conferences.Trial registration number ChiCTR2000038173. |
| format | Article |
| id | doaj-art-4b5c202148bb48988bdbb3b2d066c0cb |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2021-12-01 |
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| spelling | doaj-art-4b5c202148bb48988bdbb3b2d066c0cb2024-12-09T16:40:10ZengBMJ Publishing GroupBMJ Open2044-60552021-12-01111210.1136/bmjopen-2020-046415Efficacy of neoadjuvant hyperthermic intraperitoneal chemotherapy in advanced high-grade serous ovarian cancer (the NHIPEC trial): study protocol for a randomised controlled trialHui Zhou0Jing Li1Qing Chen2Ji-Bin Li3Li-juan Wang4Yan-Fang Ye5Miao-Fang Wu6Chang-Hao Liu7Huai-Wu Lu8Ting-Ting Yao9Bing-Zhong Zhang10Yong-Pai Peng11Zhong-Qiu Lin121 Department of Neurology, Xiangya Hospital Central South University, Changsha, Hunan, ChinaDepartment of Epidemiology and Biostatistics, School of Public Health, Tianjin Medical University, Tianjin, ChinaNHC Key Laboratory of Birth Defects and Reproductive Health, Chongqing Population and Family Planning Science and Technology Research Institute, Chongqing, Chinastatistician,Department of Gynecologic Oncology, Sun Yat-sen Memorial Hospital, Guangzhou, Guangdong, Chinaassistant research fellowDepartment of Gynecologic Oncology, Sun Yat-sen Memorial Hospital, Guangzhou, Guangdong, ChinaDepartment of Gynecologic Oncology, Sun Yat-sen Memorial Hospital, Guangzhou, Guangdong, ChinaDepartment of Gynecologic Oncology, Sun Yat-sen Memorial Hospital, Guangzhou, Guangdong, ChinaDepartment of Gynecologic Oncology, Sun Yat-sen Memorial Hospital, Guangzhou, Guangdong, ChinaDepartment of Gynecologic Oncology, Sun Yat-sen Memorial Hospital, Guangzhou, Guangdong, ChinaDepartment of Gynecologic Oncology, Sun Yat-sen Memorial Hospital, Guangzhou, Guangdong, ChinaDepartment of Gynecologic Oncology, Sun Yat-sen Memorial Hospital, Guangzhou, Guangdong, ChinaBackground Neoadjuvant chemotherapy (NACT) is an important treatment option for patients with ovarian cancer. Although intravenous NACT can improve optimal resection rates and decrease surgical morbidity and mortality, these advantages do not translate into a survival benefit. Ovarian carcinoma is mainly confined to the peritoneal cavity, which makes it a potential target for hyperthermic intraperitoneal chemotherapy (HIPEC). Our previous study showed that HIPEC could be used in the neoadjuvant setting, which was named neoadjuvant HIPEC (NHIPEC). Since hyperthermia is an excellent chemosensitiser, we hypothesised that the combination of NHIPEC and intravenous NACT could show superior efficacy to intravenous NACT alone.Methods This study is a single-centre, open-label, randomised (1:1 allocation ratio) phase 2 trial. A total of 80 patients will be randomly assigned into an experimental group (NHIPEC+intravenous NACT) or a control group (intravenous NACT). Patients in the experimental group will receive NHIPEC following laparoscopic evaluation, and four tubes will be placed via the laparoscopic ports, which will be used to administer NHIPEC. Then, perfusion with docetaxel (60–75 mg/m2) will be performed (43°C for 60 min, Day 0) followed by cisplatin (75 mg/m2, Day 1) infusion (43°C for 60 min) 24 hours later. After NHIPEC, two cycles of intravenous NACT will be given. Patients in the control group will receive three cycles of intravenous NACT. The primary endpoint is the proportion of patients who achieve a Chemotherapy Response Score (CRS) of 3 according to the CRS system. The secondary endpoints include progression-free survival, overall survival and the rates of complete resection and NHIPEC-related adverse events.Ethics approval and dissemination This study was approved by the Ethics Committee of Sun Yat-sen Memorial Hospital (approval number: 2020-ky-050). Results will be submitted to peer-reviewed journals and presented at national and international conferences.Trial registration number ChiCTR2000038173.https://bmjopen.bmj.com/content/11/12/e046415.full |
| spellingShingle | Hui Zhou Jing Li Qing Chen Ji-Bin Li Li-juan Wang Yan-Fang Ye Miao-Fang Wu Chang-Hao Liu Huai-Wu Lu Ting-Ting Yao Bing-Zhong Zhang Yong-Pai Peng Zhong-Qiu Lin Efficacy of neoadjuvant hyperthermic intraperitoneal chemotherapy in advanced high-grade serous ovarian cancer (the NHIPEC trial): study protocol for a randomised controlled trial BMJ Open |
| title | Efficacy of neoadjuvant hyperthermic intraperitoneal chemotherapy in advanced high-grade serous ovarian cancer (the NHIPEC trial): study protocol for a randomised controlled trial |
| title_full | Efficacy of neoadjuvant hyperthermic intraperitoneal chemotherapy in advanced high-grade serous ovarian cancer (the NHIPEC trial): study protocol for a randomised controlled trial |
| title_fullStr | Efficacy of neoadjuvant hyperthermic intraperitoneal chemotherapy in advanced high-grade serous ovarian cancer (the NHIPEC trial): study protocol for a randomised controlled trial |
| title_full_unstemmed | Efficacy of neoadjuvant hyperthermic intraperitoneal chemotherapy in advanced high-grade serous ovarian cancer (the NHIPEC trial): study protocol for a randomised controlled trial |
| title_short | Efficacy of neoadjuvant hyperthermic intraperitoneal chemotherapy in advanced high-grade serous ovarian cancer (the NHIPEC trial): study protocol for a randomised controlled trial |
| title_sort | efficacy of neoadjuvant hyperthermic intraperitoneal chemotherapy in advanced high grade serous ovarian cancer the nhipec trial study protocol for a randomised controlled trial |
| url | https://bmjopen.bmj.com/content/11/12/e046415.full |
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