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

Not Applicable

Active, not recruiting

• Conditions: Cervical Cancer; Surgery; Quality of Life
• Interventions: Procedure: no systematic pelvic lymphadenectomy

• Registration Number: NCT02642471
• Lead Sponsor: Sun Yat-sen University

Brief Summary

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.

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 Timeline

• Study First Submitted: 2015-12-24
• Study First Submitted QC: 2015-12-29
• Study First Posted: 2015-12-30
• Study Start: 2015-12-31
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-10
• Last Update Posted: 2024-12-16
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 1080

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 3	no systematic pelvic lymphadenectomy	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
Arm 1	no systematic pelvic lymphadenectomy	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

Primary Outcome Measures

Name	Time	Method
Disease free survival in PHENIX-II	2 years
Disease free survival in PHENIX-I	3 years

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Gynecologic Oncology, Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China