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NCT Number: 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

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.

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Key information

Conditions

Uterine Cervical Dysplasia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Precancerous Conditions Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Service de Gynécologie, Hôpital Femme Mère Enfant

Bron, 69677, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

identification of sentinel nodes + full pelvic lymph-node dissection

Procedure

identification of sentinel nodes + full pelvic lymph-node dissection

only identification of sentinel nodes (without pelvic lymph-node dissection)

Procedure

only identification of sentinel nodes (without pelvic lymph-node dissection)

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. the costs of both studied strategies

    Time frame: At the surgery until 6 months

  3. the detection rate of the sentinel node technique in the 2 arms

    Time frame: Day 1

  4. the false negative rate in the control arm

    Time frame: Day 1

  5. the sites of recurrence for each strategy

    Time frame: Day 1

  6. Number of patients without 3 years-recurrence for each strategy

    Time frame: 3 years after surgery

  7. 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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study 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

Acronym: SENTICOL2

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Jul 13, 2012
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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