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)

November 23, 2018 updated by: Hospices Civils de Lyon

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

267

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bron, France, 69677
        • Service de Gynécologie, Hôpital Femme Mère Enfant

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Strategy A
Only identification of sentinel nodes (without pelvic lymph-node dissection)
Procedure: only identification of sentinel nodes (without pelvic lymph-node dissection)
only identification of sentinel nodes (without pelvic lymph-node dissection)
Other: Strategy B
Identification of sentinel nodes + full pelvic lymph-node dissection
Procedure: identification of sentinel nodes + full pelvic lymph-node dissection
identification of sentinel nodes + full pelvic lymph-node dissection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants with complications observed in the 2 arms during the per and post-operative period up to 6 months
Time Frame: 6 months after surgery
6 months after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Score of the questionnaire of quality of life at 30 days, 3 months and 6 months after surgery
Time Frame: 30 days, 3 months and 6 months after surgery
30 days, 3 months and 6 months after surgery
the costs of both studied strategies
Time Frame: At the surgery until 6 months
At the surgery until 6 months
the detection rate of the sentinel node technique in the 2 arms
Time Frame: Day 1
Day 1
the false negative rate in the control arm
Time Frame: Day 1
Day 1
the sites of recurrence for each strategy
Time Frame: Day 1
Day 1
Number of patients without 3 years-recurrence for each strategy
Time Frame: 3 years after surgery
3 years after surgery
Number of patient treated by radio chemotherapy because of the presence of micrometastases in the sentinel node
Time Frame: 30 days, 3 months and 6 months after surgery
30 days, 3 months and 6 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

September 7, 2010

First Submitted That Met QC Criteria

July 12, 2012

First Posted (Estimate)

July 13, 2012

Study Record Updates

Last Update Posted (Actual)

November 27, 2018

Last Update Submitted That Met QC Criteria

November 23, 2018

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008.515

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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