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)

Civil Hospices of Lyon

Status: Completed

Conditions: Uterine Cervical Dysplasia

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01639820

2008.515

Details and patient eligibility

About

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.

Enrollment: 267 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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267 participants in 2 patient groups

Strategy A

Experimental group

Description:

Only identification of sentinel nodes (without pelvic lymph-node dissection)

Treatment:

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

Strategy B

Other group

Description:

Identification of sentinel nodes + full pelvic lymph-node dissection

Treatment:

Procedure: identification of sentinel nodes + full pelvic lymph-node dissection