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Comparison of Pelvic Lymphadenectomy Versus Isolated Sentinel Lymph Node Biopsy Procedure for Early Stages of Cervical Cancers : a Multicenter Study With Evaluation of Medico-economic Impacts (SENTICOL2)

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ClinicalTrials.gov Identifier: NCT01639820
Recruitment Status : Completed
First Posted : July 13, 2012
Last Update Posted : November 27, 2018
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Tracking Information
First Submitted Date  ICMJE September 7, 2010
First Posted Date  ICMJE July 13, 2012
Last Update Posted Date November 27, 2018
Study Start Date  ICMJE January 2009
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 23, 2018)
Number of Participants with complications observed in the 2 arms during the per and post-operative period up to 6 months [ Time Frame: 6 months after surgery ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 12, 2012)
  • Number of Participants with complications observed in the 2 arms in the short-term (30 days after surgery) [ Time Frame: 30 days after surgery ]
  • Number of Participants with complications observed in the 2 arms in the middle term (6 months after surgery) [ Time Frame: 6 months after surgery ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 12, 2012)
  • Score of the questionnaire of quality of life at 30 days, 3 months and 6 months after surgery [ Time Frame: 30 days, 3 months and 6 months after surgery ]
  • the costs of both studied strategies [ Time Frame: At the surgery until 6 months ]
  • the detection rate of the sentinel node technique in the 2 arms [ Time Frame: Day 1 ]
  • the false negative rate in the control arm [ Time Frame: Day 1 ]
  • the sites of recurrence for each strategy [ Time Frame: Day 1 ]
  • Number of patients without 3 years-recurrence for each strategy [ Time Frame: 3 years after surgery ]
  • Number of patient treated by radio chemotherapy because of the presence of micrometastases in the sentinel node [ Time Frame: 30 days, 3 months and 6 months after surgery ]
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 Comparison of Pelvic Lymphadenectomy Versus Isolated Sentinel Lymph Node Biopsy Procedure for Early Stages of Cervical Cancers : a Multicenter Study With Evaluation of Medico-economic Impacts
Official Title  ICMJE Comparison of Pelvic Lymphadenectomy Versus Isolated Sentinel Lymph Node Biopsy Procedure for Early Stages of Cervical Cancers : a Randomized Multicenter Study With Evaluation of Medico-economic Impacts
Brief Summary

Patients with early cervical cancer are usually treated with radical hysterectomy + pelvic lymph-node dissection. The study randomizes patients in 2 arms. The control arm is the classical surgical treatment including identification of the sentinel nodes, full pelvic lymph-node dissection and radical hysterectomy.

The experimental arm is only sentinel node identification + radical hysterectomy.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Uterine Cervical Dysplasia
Intervention  ICMJE
  • Procedure: identification of sentinel nodes + full pelvic lymph-node dissection
    identification of sentinel nodes + full pelvic lymph-node dissection
  • Procedure: only identification of sentinel nodes (without pelvic lymph-node dissection)
    only identification of sentinel nodes (without pelvic lymph-node dissection)
Study Arms  ICMJE
  • Experimental: Strategy A
    Only identification of sentinel nodes (without pelvic lymph-node dissection)
    Intervention: Procedure: only identification of sentinel nodes (without pelvic lymph-node dissection)
  • Strategy B
    Identification of sentinel nodes + full pelvic lymph-node dissection
    Intervention: Procedure: identification of sentinel nodes + full pelvic lymph-node dissection
Publications * Bats AS, Frati A, Mathevet P, Orliaguet I, Querleu D, Zerdoud S, Leblanc E, Gauthier H, Uzan C, Deandreis D, Darai E, Kerrou K, Marret H, Lenain E, Froissart M, Lecuru F. Contribution of lymphoscintigraphy to intraoperative sentinel lymph node detection in early cervical cancer: Analysis of the prospective multicenter SENTICOL cohort. Gynecol Oncol. 2015 May;137(2):264-9. doi: 10.1016/j.ygyno.2015.02.018. Epub 2015 Feb 26.

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: August 21, 2013)
267
Original Estimated Enrollment  ICMJE
 (submitted: July 12, 2012)
280
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Women 18 years of age or older,
  • Absence of contraindication to laparoscopy,
  • Uterine cervical carcinoma (every histological type except neuroendocrine),
  • Stage IA1 with lymphatic tumor space involvement (LVSI) or IA2 diagnosed on cervical conization; or stage IA2, IB1 or IIA detected by clinical examination, confirmed by biopsy and measured by the MRI, the highest diameter being lower to 4 cm (a preoperative brachytherapy is allowed for tumors 2 to 4 cm in diameter),
  • Negative pregnancy test for women able to procreate,
  • Having the French National Social Security
  • Signed informed consent

Exclusion Criteria:

  • Neuroendocrine carcinoma,
  • In situ carcinoma or stage IA1 without LVSI,
  • Maximal tumoral diameter measured by MRI more than 4 cm,
  • Stage IB1 by "down-staging",
  • Stage IB2, IIB to IVB, including those who had a response to neoadjuvant treatment (chemotherapy or RT + chemotherapy) ,
  • Presence of distant metastases,
  • Progression of the cervical cancer or recurrence,
  • History of pelvic lymphadenectomy,
  • Other cancer diagnosed during the course of treatment,
  • Contraindication to the injected products : allergy known to Patent Blue or rhenium sulfide,
  • History of severe allergy (history of Quincke's edema, anaphylactic shock),
  • Patient who does not understand, speak or write the French language,
  • Pregnant woman
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01639820
Other Study ID Numbers  ICMJE 2008.515
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hospices Civils de Lyon
Study Sponsor  ICMJE Hospices Civils de Lyon
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Hospices Civils de Lyon
Verification Date December 2011

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