Clinical trial NCT01639820: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Uterine Cervical Dysplasia
Keywords: 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
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2012-07-13
Enrollment: 267
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants with complications observed in the 2 arms during the per and post-operative period up to 6 months
timeFrame: 6 months after surgery
Secondary outcomes:
measure: Score of the questionnaire of quality of life at 30 days, 3 months and 6 months after surgery
timeFrame: 30 days, 3 months and 6 months after surgery
measure: the costs of both studied strategies
timeFrame: At the surgery until 6 months
measure: the detection rate of the sentinel node technique in the 2 arms
timeFrame: Day 1
measure: the false negative rate in the control arm
timeFrame: Day 1
measure: the sites of recurrence for each strategy
timeFrame: Day 1
measure: Number of patients without 3 years-recurrence for each strategy
timeFrame: 3 years after surgery
measure: Number of patient treated by radio chemotherapy because of the presence of micrometastases in the sentinel node
timeFrame: 30 days, 3 months and 6 months after surgery
Other outcomes:
Locations:
city: Bron
country: France
facility: Service de Gynécologie, Hôpital Femme Mère Enfant
Study officials:
References:
citation: Bats AS, Frati A, Mathevet P, Orliaguet I, Querleu D, Zerdoud S, Leblanc E, Gauthier H, Uzan C, Deandreis D, Darai E, Kerrou K, Marret H, Lenain E, Froissart M, Lecuru F. Contribution of lymphoscintigraphy to intraoperative sentinel lymph node detection in early cervical cancer: Analysis of the prospective multicenter SENTICOL cohort. Gynecol Oncol. 2015 May;137(2):264-9. doi: 10.1016/j.ygyno.2015.02.018. Epub 2015 Feb 26.