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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)

Primary Purpose

Uterine Cervical Dysplasia

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
identification of sentinel nodes + full pelvic lymph-node dissection
only identification of sentinel nodes (without pelvic lymph-node dissection)
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uterine Cervical Dysplasia focused on measuring Cervical cancer, early stage carcinoma, FIGO IA1 IA2 IB1 IIA, sentinel lymph node biopsy, pelvic lymphadenectomy, Surgery of uterine cervical carcinoma, medico economic impact, quality of life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Service de Gynécologie, Hôpital Femme Mère Enfant

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Strategy A

Strategy B

Arm Description

Only identification of sentinel nodes (without pelvic lymph-node dissection)

Identification of sentinel nodes + full pelvic lymph-node dissection

Outcomes

Primary Outcome Measures

Number of Participants with complications observed in the 2 arms during the per and post-operative period up to 6 months

Secondary Outcome Measures

Score of the questionnaire of quality of life at 30 days, 3 months and 6 months after surgery
the costs of both studied strategies
the detection rate of the sentinel node technique in the 2 arms
the false negative rate in the control arm
the sites of recurrence for each strategy
Number of patients without 3 years-recurrence for each strategy
Number of patient treated by radio chemotherapy because of the presence of micrometastases in the sentinel node

Full Information

First Posted
September 7, 2010
Last Updated
November 23, 2018
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT01639820
Brief Title
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
Acronym
SENTICOL2
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Cervical Dysplasia
Keywords
Cervical cancer, early stage carcinoma, FIGO IA1 IA2 IB1 IIA, sentinel lymph node biopsy, pelvic lymphadenectomy, Surgery of uterine cervical carcinoma, medico economic impact, quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
267 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Strategy A
Arm Type
Experimental
Arm Description
Only identification of sentinel nodes (without pelvic lymph-node dissection)
Arm Title
Strategy B
Arm Type
Other
Arm Description
Identification of sentinel nodes + full pelvic lymph-node dissection
Intervention Type
Procedure
Intervention Name(s)
identification of sentinel nodes + full pelvic lymph-node dissection
Intervention Description
identification of sentinel nodes + full pelvic lymph-node dissection
Intervention Type
Procedure
Intervention Name(s)
only identification of sentinel nodes (without pelvic lymph-node dissection)
Intervention Description
only identification of sentinel nodes (without pelvic lymph-node dissection)
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
the costs of both studied strategies
Time Frame
At the surgery until 6 months
Title
the detection rate of the sentinel node technique in the 2 arms
Time Frame
Day 1
Title
the false negative rate in the control arm
Time Frame
Day 1
Title
the sites of recurrence for each strategy
Time Frame
Day 1
Title
Number of patients without 3 years-recurrence for each strategy
Time Frame
3 years after surgery
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Service de Gynécologie, Hôpital Femme Mère Enfant
City
Bron
ZIP/Postal Code
69677
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
25727652
Citation
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.
Results Reference
derived
Links:
URL
http://www.e-cancer.fr/recherche/recherche-clinique/registre-des-essais-cliniques/registre-des-essais-cliniques?task=detailEtude&idFiche=1150
Description
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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

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