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

Sponsor

Sun Yat-sen University (Other)

Overall Status

Recruiting

CT.gov ID

NCT02642471

Collaborator

(none)

1,080

Enrollment

Location

Arms

Anticipated Duration (Months)

12.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cervical Cancer Surgery Quality of Life	Procedure: no systematic pelvic lymphadenectomy	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

1080 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 1, 2015

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Disease free survival in PHENIX-I [3 years]
Disease free survival in PHENIX-II [2 years]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.