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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01639820
Other study ID # 2008.515
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2009
Est. completion date December 2012

Study information

Verified date December 2011
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 267
Est. completion date December 2012
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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


Intervention

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

Locations

Country Name City State
France Service de Gynécologie, Hôpital Femme Mère Enfant Bron

Sponsors (1)

Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary the costs of both studied strategies At the surgery until 6 months
Secondary the detection rate of the sentinel node technique in the 2 arms Day 1
Secondary the false negative rate in the control arm Day 1
Secondary the sites of recurrence for each strategy Day 1
Secondary Number of patients without 3 years-recurrence for each strategy 3 years after surgery
Secondary 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
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