We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
ClinicalTrials.gov Menu

Neoadjuvant Chemotherapy and Radical Surgery in Stage IIB Cervical Cancer (SYSGO002)

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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02595554
Recruitment Status : Unknown
Verified February 2017 by Jihong Liu, Sun Yat-sen University.
Recruitment status was:  Recruiting
First Posted : November 3, 2015
Last Update Posted : February 3, 2017
Information provided by (Responsible Party):
Jihong Liu, Sun Yat-sen University

Tracking Information
First Submitted Date  ICMJE November 2, 2015
First Posted Date  ICMJE November 3, 2015
Last Update Posted Date February 3, 2017
Study Start Date  ICMJE November 2015
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 2, 2015)
Disease free survival [ Time Frame: 5 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 2, 2015)
Overall survival [ Time Frame: 5 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Neoadjuvant Chemotherapy and Radical Surgery in Stage IIB Cervical Cancer
Official Title  ICMJE Neoadjuvant Chemotherapy and Radical Surgery Versus Concurrent Chemoirradiation in FIGO Stage IIB Cervical Cancer
Brief Summary Neoadjuvant chemotherapy (NACT) and radical surgery (RS) may have a possible better outcome to concurrent chemoirradiation (CCRT) in stage IIB cervical cancer. We try to verify such a hypothesis in terms of survival and treatment related morbidity.
Detailed Description Patients with International Federation of Gynecology and Obstetrics (FIGO) stage IIB cervical cancer are eligible for our study. They will receive cisplatin based neoadjuvant chemotherapy (NACT) 3 cycles followed by radical surgery (RS) (type III to V radical hysterectomy plus systematic pelvic lymphadenectomy) (arm A) or external beam radiation (EBRT) with concurrent weekly platinum 40mg/m2 followed by brachyradiotherapy (arm B).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cervical Carcinoma Stage IIB
Intervention  ICMJE
  • Radiation: Concurrent chemoirradiation
    External beam radiation therapy (EBRT) with concurrent weekly platinum chemotherapy followed by brachytherapy
  • Drug: Paclitaxel
    New adjuvant chemotherapy 3 cycles with Paclitaxel 150mg/m2 over 3 hours and Cisplatin
    Other Name: NACT
  • Procedure: Radical Surgery
    Radical hysterectomy (Type III or Type IV hysterectomy) plus bilateral pelvic lymph node dissection and para-aortic lymph node dissection or sampling
    Other Name: NACT and surgery
  • Drug: Cisplatin
    New adjuvant chemotherapy 3 cycles with Paclitaxel and Cisplatin 70mg/m2
    Other Name: NACT
Study Arms  ICMJE
  • Active Comparator: Concurrent chemoirradiation (CCRT)
    Concurrent chemoirradiation
    Intervention: Radiation: Concurrent chemoirradiation
  • Experimental: NACT+Surgery
    Neoadjuvant chemotherapy with Paclitaxel and Cisplatin (3 cycles), followed by radical surgery
    • Drug: Paclitaxel
    • Procedure: Radical Surgery
    • Drug: Cisplatin
Publications * Tu H, Huang H, Ouyang Y, Liu Q, Xian B, Song K, Chen G, Shen Y, Liu J. Neoadjuvant chemotherapy followed by radical surgery versus concurrent chemoradiotherapy in patients with FIGO stage IIB cervical cancer: the CSEM 006 study. Int J Gynecol Cancer. 2021 Jan;31(1):129-133. doi: 10.1136/ijgc-2020-001357. Epub 2020 Jun 9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 2, 2015)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with newly histologically confirmed cervical carcinoma
  • Original clinical stage must be IIB (FIGO 2009)
  • Histopathology squamous carcinoma, adenocarcinoma or adeno-squamous carcinoma
  • Age between 18-65
  • Patients must give signed informed consent

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/mm3
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT02595554
Other Study ID Numbers  ICMJE CSEM007
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Jihong Liu, Sun Yat-sen University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Sun Yat-sen University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Jihong Liu, Ph. D Sun Yat-sen University
PRS Account Sun Yat-sen University
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP