Comparison of Pelvic Lymphadenectomy Versus Isolated Sentinel Lymph Node Biopsy Procedure for Ear… (NCT01639820) | Clinical Trial Compass
CompletedNot Applicable
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
France267 participantsStarted 2009-01
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Number of Participants with complications observed in the 2 arms during the per and post-operative period up to 6 months