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Clinical trial
Sentinel lymph node biopsy versus pelvic lymphadenectomy in early-stage cervical cancer: a multi-center randomized trial (PHENIX/CSEM 010)
  1. Hua Tu1,
  2. He Huang1,
  3. Bingna Xian1,
  4. Jibin Li2,
  5. Ping Wang3,
  6. Weidong Zhao4,
  7. Xiaojun Chen5,
  8. Xing Xie6,
  9. Chunyan Wang7,
  10. Beihua Kong8,
  11. Jing Xiao9,
  12. Ping Zhang10 and
  13. Jihong Liu1
  14. on behalf of the PHENIX Investigators and the CSEM group
  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. 2Clinical Trial Center, 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 Gynecology, West China Second University Hospital, Sichuan University, Chengdu, China
  4. 4Department of Gynecologic Oncology, Anhui Provincial Cancer Hospital, Hefei, China
  5. 5Department of Gynecologic Oncology, Obstetrics & Gynecology Hospital of Fudan University, Shanghai, China
  6. 6Department of Gynecologic Oncology, Women's Hospital of Zhejiang University, Hangzhou, China
  7. 7Department of Gynecologic Oncology, Liaoning Cancer Hospital, Shenyang, China
  8. 8Department of Gynecology, Qilu Hospital of Shandong University, Jinan, China
  9. 9Department of Gynecology, Guangdong Province Traditional Chinese Medical Hospital, Guangzhou, China
  10. 10Department of Gynecologic Oncology, Zhejiang Cancer Hospital, Hangzhou, China
  1. Correspondence to Dr Jihong Liu, 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; liujih{at}mail.sysu.edu.cn

Abstract

Background There is no accepted strategy for applying sentinel lymph node (SLN) biopsy as an alternative to pelvic lymphadenectomy in cervical cancer. It is unclear whether and when pelvic lymphadenectomy can be safely replaced by SLN biopsy alone.

Primary Objective To comprehensively compare the oncological outcomes of SLN biopsy with pelvic lymphadenectomy in patients with and without SLN metastasis.

Study Hypothesis It is hypothesized that the oncological outcomes provided by SLN biopsy are non-inferior to those of pelvic lymphadenectomy in patients with clinically early-stage cervical cancer if risk-adapted adjuvant treatments are given.

Trial Design All eligible patients will undergo SLN biopsy at the start of surgery. The resected SLNs will be submitted for frozen section examination. and patients will be triaged into the PHENIX-I (SLN-negative) or PHENIX-II (SLN-positive) cohort. In each cohort of this trial, patients will be randomized in a 1:1 ratio into the experimental (SLN biopsy alone) or reference (pelvic lymphadenectomy) arm. Radical hysterectomy will be performed for all patients, and adjuvant treatments will be planned according to post-operative pathological factors.

Major Inclusion/Exclusion Criteria Patients aged between 18 and 65 years with histologically confirmed, untreated stage IA1 (lymphovascular space involvement), IA2, IB1, and IB2 cervical squamous carcinoma, adenocarcinoma, or adenosquamous carcinoma.

Primary Endpoint The primary endpoint is disease-free survival.

Sample Size Estimated sample sizes of 830 and 250 are required to fulfill the study objectives of PHENIX-I and II, respectively.

Estimated Dates for Completing Accrual and Presenting Results As of May 2020, more than 600 eligible patients have been enrolled. Enrollment is expected to be completed by December 2022, and presentation of results is expected in 2026.

Trial Registration NCT02642471.

  • cervical cancer
  • gynecologic surgical procedures
  • pathology
  • SLN and lympadenectomy

https://doi.org/10.1136/ijgc-2020-001857

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    Footnotes

    • HT and HH contributed equally.

    • Contributors HT, HH, and J-HL designed the study and wrote the manuscript. B-NX collected the data. J-BL designed the statistical methods. All the authors will participate in the trial and lead it in their respective institution.

    • Funding This work was supported by the Health and Medical Cooperation Innovation Special Program of Guangzhou Municipal Science and Technology (grant number: 158100075).

    • Competing interests None declared.

    • Patient consent for publication Not required.

    • Ethics approval Ethics Committee Board of Sun Yat-sen University Cancer Center.

    • Provenance and peer review Commissioned; internally peer reviewed.

    • Data availability statement There are no data in this work.