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
Not Applicable
Completed
- Conditions
- Uterine Cervical Dysplasia
- Interventions
- Procedure: only identification of sentinel nodes (without pelvic lymph-node dissection)Procedure: identification of sentinel nodes + full pelvic lymph-node dissection
- Registration Number
- NCT01639820
- Lead Sponsor
- Hospices Civils de Lyon
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 267
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Strategy A 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 Identification of sentinel nodes + full pelvic lymph-node dissection
- Primary Outcome Measures
Name Time Method 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
Name Time Method the sites of recurrence for each strategy Day 1 the detection rate of the sentinel node technique in the 2 arms Day 1 the false negative rate in the control arm Day 1 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 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
Trial Locations
- Locations (1)
Service de Gynécologie, Hôpital Femme Mère Enfant
🇫🇷Bron, France