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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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT01639820
First received: September 7, 2010
Last updated: August 21, 2013
Last verified: December 2011
  Purpose

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 Intervention
Uterine Cervical Dysplasia
Procedure: identification of sentinel nodes + full pelvic lymph-node dissection
Procedure: only identification of sentinel nodes (without pelvic lymph-node dissection)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • Number of Participants with complications observed in the 2 arms in the short-term (30 days after surgery) [ Time Frame: 30 days after surgery ] [ Designated as safety issue: Yes ]
  • Number of Participants with complications observed in the 2 arms in the middle term (6 months after surgery) [ Time Frame: 6 months after surgery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • the costs of both studied strategies [ Time Frame: At the surgery until 6 months ] [ Designated as safety issue: No ]
  • the detection rate of the sentinel node technique in the 2 arms [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • the false negative rate in the control arm [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • the sites of recurrence for each strategy [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Number of patients without 3 years-recurrence for each strategy [ Time Frame: 3 years after surgery ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 267
Study Start Date: January 2009
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01639820

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

Additional Information:
No publications provided

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01639820     History of Changes
Other Study ID Numbers: 2008.515
Study First Received: September 7, 2010
Last Updated: August 21, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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:
Cervical Intraepithelial Neoplasia
Uterine Cervical Dysplasia
Uterine Cervical Neoplasms
Carcinoma
Carcinoma in Situ
Genital Diseases, Female
Genital Neoplasms, Female
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Precancerous Conditions
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Uterine Neoplasms

ClinicalTrials.gov processed this record on November 27, 2014