Sentinel Lymph Node Biopsy Versus Pelvic Lymphadenectomy in Early-stage Cervical Cancer (PHENIX/CSEM 010)

The diagnostic value of sentinel lymph node biopsy in early-stage cervical cancer has been well studied. However, there were no randomized controlled study on comparing the long-term outcomes of sentinel lymph node biopsy and conventional procedure. The investigators perform a phase III, randomized controlled trial to determine whether pelvic lymphadenectomy can be replaced by sentinel lymph node biopsy in surgical treatment for patients with early-stage cervical cancer.

Study Overview

• Status: Active, not recruiting
• Conditions: Quality of Life; Cervical Cancer; Surgery
• Intervention / Treatment: Procedure: no systematic pelvic lymphadenectomy

Detailed Description

This study comprises two parts: PHENIX-I: To compare the outcomes of managements with and without pelvic lymphadenectomy for patients with negative sentinel lymph node; PHENIX-II: To compare the outcomes of managements with and without pelvic lymphadenectomy for patients with positive sentinel lymph node. Patients with newly diagnosed International Federation of Gynecology and Obstetrics (FIGO) stage IA1 (lymphovascular space involvement), IA2, IB1, and IB2 cervical cancer are eligible for our study. The tumor diameter should be less than 3cm. Sentinel lymph node biopsy will be performed at the beginning of operations. After pathological examination of frozen section, patients will be assigned to PHENIX-I or PHENIX-II study according to their status of sentinel nodes. In both parts of this trail, patients have equal chance to be randomly assigned to experimental arms (radical hysterectomy only) and reference arms (radical hysterectomy and pelvic lymphadenectomy).Adjuvant treatments will be planned according to postoperative pathological factors. The primary objective is disease-free survival at 3 years for PHENIX-I and 2 years for PHENIX-II. The secondary end points are overall survival, long-term outcome of sentinel lymph node biopsy and the quality of life.

• Study Type: Interventional
• Enrollment (Estimated): 1080
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Department of Gynecologic Oncology, Sun Yat-sen University Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients with newly histologically confirmed cervical carcinoma
• Histopathology squamous carcinoma, adenocarcinoma or adeno-squamous carcinoma
• Original clinical stage must be FIGO (2018) stage IA1 (lymphovascular space involvement), IA2, IB1, IB2 and IIA1
• No suspected node should be found on imaging examination (RESIST 1.1)
• Age between 18-65
• Patients must give signed informed consent
• P.S status: 0-1
• Estimated survival time > 3 months
• Tumor diameter ≤ 3 cm

Exclusion Criteria:

• The presence of uncontrolled life-threatening illness
• Receiving other ways of anti-cancer therapy
• Investigator consider the patients can't finish the whole study
• With normal liver function test (ALT、AST>2.5×ULN)
• With normal renal function test (Creatinine>1.5×ULN)
• WBC<4,000/mm3 or PLT<100,000/mm
• The whole cervix has been occupied by tumor and there is no normal surface left for tracer injection
• History of severe heart disease or deep venous thrombosis; 4) Presence or history of other malignant disease
• Gestation or perinatal period
• Intention to fertility preservation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1; patients with negative sentinel nodes confirmed by pathological examination of frozen section will be randomly assigned to Arm 1 or Arm 2 Arm 1: patients undergo radical hysterectomy±salpingo-oophorectomy (no systematic pelvic lymphadenectomy) Arm 2: patients undergo radical hysterectomy±salpingo-oophorectomy+pelvic lymph node dissection	Procedure: no systematic pelvic lymphadenectomy; systematic pelvic lymphadenectomy is omitted in surgical treatment
No Intervention: Arm 2; patients with negative sentinel nodes confirmed by pathological examination of frozen section will be randomly assigned to Arm 1 or Arm 2 Arm 1: patients undergo radical hysterectomy±salpingo-oophorectomy (no systematic pelvic lymphadenectomy) Arm 2: patients undergo radical hysterectomy±salpingo-oophorectomy+pelvic lymph node dissection
Experimental: Arm 3; patients with positive sentinel nodes confirmed by pathological examination of frozen section will be randomly assigned to Arm 3 or Arm 4 Arm 3: patients undergo radical hysterectomy±salpingo-oophorectomy (no systematic pelvic lymphadenectomy) Arm 4: patients undergo radical hysterectomy±salpingo-oophorectomy+pelvic lymph node dissection	Procedure: no systematic pelvic lymphadenectomy; systematic pelvic lymphadenectomy is omitted in surgical treatment
No Intervention: Arm 4; patients with positive sentinel nodes confirmed by pathological examination of frozen section will be randomly assigned to Arm 3 or Arm 4 Arm 3: patients undergo radical hysterectomy±salpingo-oophorectomy (no systematic pelvic lymphadenectomy) Arm 4: patients undergo radical hysterectomy±salpingo-oophorectomy+pelvic lymph node dissection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Disease free survival in PHENIX-I	3 years
Disease free survival in PHENIX-II	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Surgical morbidity	3 years
Rate of retroperitoneal node recurrence	3 years
Overall survival	5 years
Patients' quality of life	5 years
Performance of SLN detection	3 years
Diagnostic accuracy of frozen section examination	3 years
Anatomic distribution of SLNs	3 years

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Investigators: Principal Investigator: Jihong Liu, Ph. D, Sun Yat-sen University

Publications and helpful links

General Publications

• Tu H, Huang H, Xian B, Li J, Wang P, Zhao W, Chen X, Xie X, Wang C, Kong B, Xiao J, Zhang P, Liu J; PHENIX Investigators and the CSEM group. Sentinel lymph node biopsy versus pelvic lymphadenectomy in early-stage cervical cancer: a multi-center randomized trial (PHENIX/CSEM 010). Int J Gynecol Cancer. 2020 Nov;30(11):1829-1833. doi: 10.1136/ijgc-2020-001857. Epub 2020 Sep 24.

Study record dates

Study Major Dates

• Study Start (Actual): December 31, 2015
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: December 24, 2015
• First Submitted That Met QC Criteria: December 29, 2015
• First Posted (Estimated): December 30, 2015

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 10, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: radiotherapy; surgery; sentinel lymph node; pelvic lymphadenectomy; cervical carcinoma
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Uterine Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Neoplasms; Uterine Cervical Neoplasms
• Other Study ID Numbers: 2015-FXY-073

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No