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Sentinel Lymph Node Biopsy Versus Systematic Pelvic Lymphadenectomy in Early-stage Cervival Cancer

This study is currently recruiting participants.
Verified December 2015 by Jihong Liu, Sun Yat-sen University
Sponsor:
ClinicalTrials.gov Identifier:
NCT02642471
First Posted: December 30, 2015
Last Update Posted: December 30, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Jihong Liu, Sun Yat-sen University
  Purpose
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 could be replaced by sentinel lymph node biopsy in surgical treatment for patients with early-stage cervical cancer.

Condition Intervention Phase
Cervical Cancer Surgery Quality of Life Procedure: no systematic pelvic lymphadnectomy Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Application of Sentinel Lymph Node Biopsy (SLNB) in Early-stage Cervical Cancer: A Prospective Study

Resource links provided by NLM:


Further study details as provided by Jihong Liu, Sun Yat-sen University:

Primary Outcome Measures:
  • Disease free survival [ Time Frame: 2 years ]
  • Recurrence of retroperitoneal lymph nodes [ Time Frame: 2 years ]

Secondary Outcome Measures:
  • overall survival [ Time Frame: 5 years ]
  • quality of life [ Time Frame: 5 years ]
  • long-term outcome of sentinel lymph node biopsy [ Time Frame: 5 years ]

Estimated Enrollment: 800
Study Start Date: December 2015
Estimated Study Completion Date: December 2022
Estimated Primary Completion Date: December 2022 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 lymphadnectomy) Arm 2: patients undergo radical hysterectomy±salpingo-oophorectomy+pelvic lymph node dissection
Procedure: no systematic pelvic lymphadnectomy
systematic pelvic lymphadnectomy 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 lymphadnectomy) 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 lymphadnectomy) Arm 4: patients undergo radical hysterectomy±salpingo-oophorectomy+pelvic lymph node dissection
Procedure: no systematic pelvic lymphadnectomy
systematic pelvic lymphadnectomy 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 lymphadnectomy) Arm 4: patients undergo radical hysterectomy±salpingo-oophorectomy+pelvic lymph node dissection

Detailed Description:
This study comprises two parts: Part I: To compare the outcomes of managements with and without pelvic lymphadenectomy for patients with negative sentinel lymph node; Part 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 IA2, IB1 and IIA1 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 Part I or Part 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 (undergo radical hysterectomy plus systematic pelvic lymphadenectomy) and controlled arms (undergo radical hysterectomy only). Postoperative pelvic radiotherapy will be started within 6 weeks after surgery if the patients have pelvic lymph node metastasis, parametrial involvement, deep stromal invasion or positive margin. Extended-field external beam therapy, delivering a dose of 4500cGy by a four-field technique, will be administered to patients with positive para-aortic nodes. High-dose rate brachytherapy will be delivered to the vaginal stump if patients have positive surgical margins. The primary end point is 2-years progression-free survival. The secondary end points are overall survival, long-term outcome of sentinel lymph node biopsy and the quality of life.
  Eligibility

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with newly histologically confirmed cervical carcinoma
  • Histopathology squamaous carcinoma, adenocarcinoma or adeno-squamous carcinoma
  • Original clinical stage must be IA2, IB1 or IIA1 (FIGO)
  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02642471


Contacts
Contact: Jihong Liu, Ph. D 86-20-87343102 liujih@mail.sysu.edu.cn
Contact: Hua Tu, Ph. D 86-20-87343014 tuhua@sysucc.org.cn

Locations
China, Guangdong
Department of Gynecologic Oncology, Sun Yat-sen University Cancer Center Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Jihong Liu, Ph.D.    86-20-87343102    liujih@mail.sysu.edu.cn   
Contact: Hua Tu, Ph.D.    86-20-87343104    tuhua@sysucc.org.cn   
Sponsors and Collaborators
Sun Yat-sen University
Investigators
Principal Investigator: Jihong Liu, Ph. D Sun Yat-sen University
  More Information

Responsible Party: Jihong Liu, Prof., Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02642471     History of Changes
Other Study ID Numbers: 2015-FXY-073
First Submitted: December 24, 2015
First Posted: December 30, 2015
Last Update Posted: December 30, 2015
Last Verified: December 2015

Keywords provided by Jihong Liu, Sun Yat-sen University:
sentinel lymph node
pelvic lymphadenectomy
cervical carcinoma
surgery
radiotherapy

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female