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

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02642471
• Other study ID #: 2015-FXY-073
• Status: Recruiting
• Phase: N/A
• Start date: December 2015
• Est. completion date: December 2022

Study information

• Verified date: July 2020
• Source: Sun Yat-sen University
• Contact: Jihong Liu, Ph. D
• Phone: 86-20-87343102
• Email: liujih[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1080
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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, and IB2

• 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.

Related Conditions & MeSH terms

• Cervical Cancer
• Quality of Life
• Surgery
• Uterine Cervical Neoplasms

Intervention

Procedure:
• no systematic pelvic lymphadenectomy
systematic pelvic lymphadenectomy is omitted in surgical treatment

Locations

Country	Name	City	State
China	Department of Gynecologic Oncology, Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease free survival in PHENIX-I		3 years
Primary	Disease free survival in PHENIX-II		2 years
Secondary	Surgical morbidity		3 years
Secondary	Rate of retroperitoneal node recurrence		3 years
Secondary	Overall survival		5 years
Secondary	Patients' quality of life		5 years
Secondary	Performance of SLN detection		3 years
Secondary	Diagnostic accuracy of frozen section examination		3 years
Secondary	Anatomic distribution of SLNs		3 years