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

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ClinicalTrials.gov Identifier: NCT02642471
Recruitment Status : Recruiting
First Posted : December 30, 2015
Last Update Posted : July 14, 2020
Sponsor:
Information provided by (Responsible Party):
Jihong Liu, Sun Yat-sen University

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : December 2015
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Disease free survival in PHENIX-I [ Time Frame: 3 years ]
  2. Disease free survival in PHENIX-II [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Surgical morbidity [ Time Frame: 3 years ]
  2. Rate of retroperitoneal node recurrence [ Time Frame: 3 years ]
  3. Overall survival [ Time Frame: 5 years ]
  4. Patients' quality of life [ Time Frame: 5 years ]
  5. Performance of SLN detection [ Time Frame: 3 years ]
  6. Diagnostic accuracy of frozen section examination [ Time Frame: 3 years ]
  7. Anatomic distribution of SLNs [ Time Frame: 3 years ]


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

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
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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
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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
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Principal Investigator: Jihong Liu, Ph. D Sun Yat-sen University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jihong Liu, Prof., Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02642471    
Other Study ID Numbers: 2015-FXY-073
First Posted: December 30, 2015    Key Record Dates
Last Update Posted: July 14, 2020
Last Verified: July 2020
Keywords provided by Jihong Liu, Sun Yat-sen University:
sentinel lymph node
pelvic lymphadenectomy
cervical carcinoma
surgery
radiotherapy
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases