NCT02642471

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,080

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 24, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 30, 2015

Completed
1 day until next milestone

Study Start

First participant enrolled

December 31, 2015

Completed
9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

December 16, 2024

Status Verified

December 1, 2024

Enrollment Period

9 years

First QC Date

December 24, 2015

Last Update Submit

December 10, 2024

Conditions

Cervical CancerSurgeryQuality of Life

Keywords

sentinel lymph nodepelvic lymphadenectomycervical carcinomasurgeryradiotherapy

Outcome Measures

Primary Outcomes (2)

  • Disease free survival in PHENIX-I

    3 years

  • Disease free survival in PHENIX-II

    2 years

Secondary Outcomes (7)

  • 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

  • +2 more secondary outcomes

Study Arms (4)

Arm 1

EXPERIMENTAL

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

Arm 2

NO INTERVENTION

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

Arm 3

EXPERIMENTAL

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

Arm 4

NO INTERVENTION

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

Interventions

no systematic pelvic lymphadenectomyPROCEDURE

systematic pelvic lymphadenectomy is omitted in surgical treatment

Arm 1Arm 3

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Gynecologic Oncology, Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Related Publications (2)

  • Tu H, Huang H, Li Y, Chen X, Wang C, Zheng M, Zhang Y, Zhao W, Feng Y, Wan T, Huang Y, Yu A, Lu W, Xiao J, Shan W, Zhang P, Zhu C, Wang D, Zhou H, Li J, Kong B, Feng W, Wang X, Luo R, Huang X, Li J, Lin Z, Yao S, Liu J; PHENIX Investigators. Sentinel-Lymph-Node Biopsy Alone or with Lymphadenectomy in Cervical Cancer. N Engl J Med. 2025 Oct 16;393(15):1463-1474. doi: 10.1056/NEJMoa2506267.

    PMID: 41092328DERIVED

  • 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.

    PMID: 32973117DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Jihong Liu, Ph. D

    Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

December 24, 2015

First Posted

December 30, 2015

Study Start

December 31, 2015

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

December 16, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)