Clinical trial NCT02642471: Sentinel Lymph Node Biopsy Versus Pelvic Lymphadenectomy in Early-stage Cervical Cancer (PHENIX/CSEM 010)
Official title: Sentinel Lymph Node Biopsy Versus Pelvic Lymphadenectomy in Early-stage Cervical Cancer (PHENIX/CSEM 010)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cervical Cancer
Surgery
Quality of Life
Keywords: sentinel lymph node
pelvic lymphadenectomy
cervical carcinoma
surgery
radiotherapy
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2015-12-30
Enrollment: 1080
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Disease free survival in PHENIX-I
timeFrame: 3 years
measure: Disease free survival in PHENIX-II
timeFrame: 2 years
Secondary outcomes:
measure: Surgical morbidity
timeFrame: 3 years
measure: Rate of retroperitoneal node recurrence
timeFrame: 3 years
measure: Overall survival
timeFrame: 5 years
measure: Patients' quality of life
timeFrame: 5 years
measure: Performance of SLN detection
timeFrame: 3 years
measure: Diagnostic accuracy of frozen section examination
timeFrame: 3 years
measure: Anatomic distribution of SLNs
timeFrame: 3 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Department of Gynecologic Oncology, Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Jihong Liu, Ph. D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.