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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Uterine Cervical Dysplasia

Intervention / Treatment
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* Procedure: identification of sentinel nodes + full pelvic lymph-node dissection
* Procedure: only identification of sentinel nodes (without pelvic lymph-node dissection)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Strategy A<br>Only identification of sentinel nodes (without pelvic lymph-node dissection) | Procedure: only identification of sentinel nodes (without pelvic lymph-node dissection)<br>* only identification of sentinel nodes (without pelvic lymph-node dissection)<br>|
| Other: Strategy B<br>Identification of sentinel nodes + full pelvic lymph-node dissection | Procedure: identification of sentinel nodes + full pelvic lymph-node dissection<br>* identification of sentinel nodes + full pelvic lymph-node dissection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| the costs of both studied strategies |  | At the surgery until 6 months | 
| the detection rate of the sentinel node technique in the 2 arms |  | Day 1 | 
| the false negative rate in the control arm |  | Day 1 | 
| the sites of recurrence for each strategy |  | Day 1 | 
| Number of patients without 3 years-recurrence for each strategy |  | 3 years after surgery | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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