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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

Study Description
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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.


Condition or disease Intervention/treatment Phase
Uterine Cervical Dysplasia Procedure: identification of sentinel nodes + full pelvic lymph-node dissection Procedure: only identification of sentinel nodes (without pelvic lymph-node dissection) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 267 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 2009
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Strategy A
Only identification of sentinel nodes (without 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)
Strategy B
Identification of sentinel nodes + full pelvic lymph-node dissection
 Procedure: identification of sentinel nodes + full pelvic lymph-node dissection
identification of sentinel nodes + full pelvic lymph-node dissection


Outcome Measures
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Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]
  2. the costs of both studied strategies [ Time Frame: At the surgery until 6 months ]
  3. the detection rate of the sentinel node technique in the 2 arms [ Time Frame: Day 1 ]
  4. the false negative rate in the control arm [ Time Frame: Day 1 ]
  5. the sites of recurrence for each strategy [ Time Frame: Day 1 ]
  6. Number of patients without 3 years-recurrence for each strategy [ Time Frame: 3 years after surgery ]
  7. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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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): NCT01639820


Locations
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France
Service de Gynécologie, Hôpital Femme Mère Enfant
Bron, France, 69677
Sponsors and Collaborators
Hospices Civils de Lyon
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01639820    
Other Study ID Numbers: 2008.515
First Posted: July 13, 2012    Key Record Dates
Last Update Posted: November 27, 2018
Last Verified: December 2011
Keywords provided by Hospices Civils de Lyon:
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
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Cervical Dysplasia
Cervical Intraepithelial Neoplasia
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
 Uterine Cervical Diseases
Uterine Diseases
Precancerous Conditions
Carcinoma in Situ
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type