Neoadjuvant chemotherapy followed by radical surgery versus concurrent chemoradiotherapy in patients with FIGO stage IIB cervical cancer: the CSEM 006 study
单位:[1]Department of Gynecologic Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China[2]Department of Radiology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China[3]Department of Cancer Prevention, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China[4]Department of Gynecology, Qilu Hospital of Shandong University, Jinan, China[5]Department of Gynecology, Tongji Hospital of Tongji Medical College, Wuhan, China华中科技大学同济医学院附属同济医院妇产科学系普通妇科[6]Department of Gynecologic Oncology, Women’s hospital of Zhejiang University, Hangzhou, China
Background Concurrent chemoradiotherapy is the first-line treatment for FIGO stage IIB cervical cancer. Neoadjuvant chemotherapy followed by radical surgery may provide another treatment option. Primary objective To compare the therapeutic outcomes of neoadjuvant chemotherapy followed by surgery with cisplatin-based concurrent chemoradiotherapy for stage IIB cervical cancer. Study hypothesis We hypothesize that the therapeutic effect of neoadjuvant chemotherapy combined with surgery and risk-adapted adjuvant treatment will be superior to that of concurrent chemoradiotherapy in stage IIB cervical cancer. Trial design Patients with stage IIB cervical cancer will be randomized 1:1 to neoadjuvant chemotherapy followed by surgery (Arm A) or concurrent chemoradiotherapy (Arm B). In arm A, patients will receive three cycles of paclitaxel and cisplatin followed by a type C radical hysterectomy and pelvic +/- paraaortic lymphadenectomy. Patients showing progression after neoadjuvant chemotherapy will be referred to concurrent chemoradiotherapy. Adjuvant therapy will be recommended according to the presence of pathological risks. In Arm B, all patients will receive definitive concurrent chemoradiotherapy, including external beam pelvic radiotherapy combined with concurrent weekly cisplatin followed by brachytherapy. Major inclusion/exclusion criteria Patients between 18 and 60 years with histologically confirmed, untreated stage IIB cervical squamous carcinoma, adenocarcinoma, or adeno-squamous carcinoma. Primary endpoint The primary endpoint is 2-year disease-free survival. Sample size An estimated sample size of 240 is required to fulfill the study objectives. Estimated dates for completing accrual and presenting results As of February 2020, 115 eligible patients from four institutions have been enrolled. Enrollment is expected to be completed by December 2022.
基金:
Health and Medical Cooperation Innovation Special Program of Guangzhou Municipal Science and Technology [158100075]
第一作者单位:[1]Department of Gynecologic Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China
共同第一作者:
通讯作者:
通讯机构:[1]Department of Gynecologic Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China
推荐引用方式(GB/T 7714):
Tu Hua,Huang He,Ouyang Yi,et al.Neoadjuvant chemotherapy followed by radical surgery versus concurrent chemoradiotherapy in patients with FIGO stage IIB cervical cancer: the CSEM 006 study[J].INTERNATIONAL JOURNAL OF GYNECOLOGICAL CANCER.2021,31(1):129-133.doi:10.1136/ijgc-2020-001357.
APA:
Tu, Hua,Huang, He,Ouyang, Yi,Liu, Qing,Xian, Bingna...&Liu, Jihong.(2021).Neoadjuvant chemotherapy followed by radical surgery versus concurrent chemoradiotherapy in patients with FIGO stage IIB cervical cancer: the CSEM 006 study.INTERNATIONAL JOURNAL OF GYNECOLOGICAL CANCER,31,(1)
MLA:
Tu, Hua,et al."Neoadjuvant chemotherapy followed by radical surgery versus concurrent chemoradiotherapy in patients with FIGO stage IIB cervical cancer: the CSEM 006 study".INTERNATIONAL JOURNAL OF GYNECOLOGICAL CANCER 31..1(2021):129-133