Brief Title
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
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.
Study Type
Interventional
Primary Outcome
Number of Participants with complications observed in the 2 arms during the per and post-operative period up to 6 months
Secondary Outcome
Score of the questionnaire of quality of life at 30 days, 3 months and 6 months after surgery
Condition
Uterine Cervical Dysplasia
Intervention
identification of sentinel nodes + full pelvic lymph-node dissection
Study Arms / Comparison Groups
Strategy A
Description: Only identification of sentinel nodes (without pelvic lymph-node dissection)
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
267
Start Date
January 2009
Completion Date
December 2012
Primary Completion Date
December 2012
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
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
, ,
Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT01639820
Organization ID
2008.515
Responsible Party
Sponsor
Study Sponsor
Hospices Civils de Lyon
Study Sponsor
, ,
Verification Date
December 2011