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

• 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

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2010-09-07
• Status Verified: 2011-12
• Study First Submitted QC: 2012-07-12
• Study First Posted: 2012-07-13
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Last Update Submitted: 2018-11-23
• Last Update Posted: 2018-11-27

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

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 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
the detection rate of the sentinel node technique in the 2 arms	Day 1

Trial Locations

Locations (1)

Service de Gynécologie, Hôpital Femme Mère Enfant; 🇫🇷 Bron, France