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

Uterine Cervical Dysplasia Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01639820
• Other study ID #: 2008.515
• Status: Completed
• Phase: N/A
• Start date: January 2009
• Est. completion date: December 2012

Study information

• Verified date: December 2011
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 267
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervical Intraepithelial Neoplasia
• Uterine Cervical Dysplasia
• Uterine Cervical Neoplasms

Intervention

Procedure:
• identification of sentinel nodes + full pelvic lymph-node dissection
identification of sentinel nodes + full pelvic lymph-node dissection
• only identification of sentinel nodes (without pelvic lymph-node dissection)
only identification of sentinel nodes (without pelvic lymph-node dissection)

Locations

Country	Name	City	State
France	Service de Gynécologie, Hôpital Femme Mère Enfant	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with complications observed in the 2 arms during the per and post-operative period up to 6 months		6 months after surgery
Secondary	Score of the questionnaire of quality of life at 30 days, 3 months and 6 months after surgery		30 days, 3 months and 6 months after surgery
Secondary	the costs of both studied strategies		At the surgery until 6 months
Secondary	the detection rate of the sentinel node technique in the 2 arms		Day 1
Secondary	the false negative rate in the control arm		Day 1
Secondary	the sites of recurrence for each strategy		Day 1
Secondary	Number of patients without 3 years-recurrence for each strategy		3 years after surgery
Secondary	Number of patient treated by radio chemotherapy because of the presence of micrometastases in the sentinel node		30 days, 3 months and 6 months after surgery

External Links

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