Article Text

Download PDFPDF
Neoadjuvant chemotherapy followed by radical surgery versus concurrent chemoradiotherapy in patients with FIGO stage IIB cervical cancer: the CSEM 006 study
  1. Hua Tu1,
  2. He Huang1,
  3. Yi Ouyang2,
  4. Qing Liu3,
  5. Bingna Xian1,
  6. Kun Song4,
  7. Gang Chen5,
  8. Yuanming Shen6 and
  9. Jihong Liu1
  1. 1Department 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. 2Department 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. 3Department 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. 4Department of Gynecology, Qilu Hospital of Shandong University, Jinan, China
  5. 5Department of Gynecology, Tongji Hospital of Tongji Medical College, Wuhan, China
  6. 6Department of Gynecologic Oncology, Women’s hospital of Zhejiang University, Hangzhou, China
  1. Correspondence to Professor Jihong Liu, Department of Gynecologic Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Centerfor Cancer Medicine. 651 East Dongfeng Road, Guangzhou, Guangdong, China; liujih{at}mail.sysu.edu.cn

Abstract

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.

Trial registration number ClinicalTrials. gov identifier: NCT02595554.

  • cervical cancer
  • radiotherapy
  • surgery
View Full Text

Statistics from Altmetric.com

Footnotes

  • HT and HH contributed equally.

  • Contributors All the authors will participate in the trial and lead it in their respective institution. HT and HH drafted the manuscript and J-H L revised it critically for important intellectual content. QL provided statistical support. All authors validated the final version of the submitted manuscript.

  • Funding This study was funded by the Health and Medical Cooperation Innovation Special Program of Guangzhou Municipal Science and Technology (NO. 158100075).

  • Competing interests None declared.

  • Patient consent for publication Not required.

  • Provenance and peer review Not commissioned; internally peer reviewed.

  • Data availability statement All data relevant to the study are included in the article

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.