Sentinel Lymph Node Biopsy in Patients With Early Stages Cervical Cancer
Condition: Cervical Cancer
MeSH terms: Uterine Cervical Neoplasms
Study type: Observational [Patient Registry]

Summary: 
      To evaluate whether a less radical surgical approach with sentinel lymph node biopsy is
      non-inferior to treatment with systematic pelvic lymphadenectomy.

      The null hypothesis is that the recurrence rate after SLN biopsy is non-inferior to the
      reference recurrence rate of 7 % (at the 24th month of follow-up) in patients after
      systematic pelvic lymphadenectomy, but that the less radical surgery is associated with
      significantly lower postoperative morbidity.
    

Detailed description: 
      Patients will be enrolled in the study at the time of surgery planning; at this point, a
      patient´s consent will be requested if inclusion criteria are fulfilled (histological type,
      FIGO stage, age, performance status, lymph node clinical status). The following procedures
      will be provided prior to surgery: clinical staging (MRI or EUS), medical data collection,
      adverse events assessment, lymphedema assessment, quality of life questionnaire, ECOG
      performance status, weight and height, standard pre-operative laboratory workup, pregnancy
      test if clinically indicated.

      Surgery should be done within 6 weeks of the imaging study (MRI or expert US). During the
      surgery, local or distant cancer spread outside of the cervix will be excluded, SLN will be
      detected, and all SLN will be sent for intra-operative pathologic evaluation. In patients
      with SLN detection on both sides of the pelvis no other lymph nodes will be removed and they
      will continue in the study. SLN biopsy will be followed by radical hysterectomy (type B, C1,
      or C2) or fertility-sparing procedure, according to the pre-operative plan.

      Intra-operatively, three groups of patient will be excluded from the SLN study group (though
      they can be included in the control group):

        1. Patients with intra-operative detection of more advanced disease stage (> IB1)

        2. Patients with failure to detect SLN bilaterally (either no SLN detected or only on one
           side of the pelvis)

        3. Patients with intra-operative pathologic detection of macrometastases or micrometastases
           in SLN

      In these patients who were excluded from the study group, further surgery and adjuvant
      treatment will be provided according to the institutional guidelines. These patients will
      remain in a database and reasons for their exclusion from the SLN study group will be entered
      into the SIS (Form 2).

      A control group will be established to compare postoperative morbidity in patients after SLN
      biopsy only and after complete pelvic lymphadenectomy. Patients in whom complete
      lymphadenectomy was performed at least on one side of the pelvis will be eligible for the
      control group.

      In patients, who continue in the study, all SLNs will be processed by pathologists according
      to the protocol for SLN ultrastaging (Chapter 7.4.2; Appendix 11). If macrometastases or
      micrometastases or isolated tumor cells are detected in any of the SLNs by pathologic
      ultrastaging after the surgery, adjuvant radiotherapy will be recommended to the patient. No
      adjuvant treatment will be offered to those with negative final lymph node status, confirmed
      pre-operative disease FIGO stage (IA1 - IB1), and adequately performed radical hysterectomy
      with negative parametrial and vaginal margins.

      Follow-up will consist of visits at regular intervals of 6 months after the surgery
      (additional visits in shorter intervals can be scheduled according to institutional
      guidelines). The following procedures will be provided at each visit during the follow-up
      period: pelvic examination, symptomatic lymphocele assessment, quality of life assessment (6
      and 12 months after the surgery), adverse events assessment, and secondary lower extremity
      lymphedema assessment (maximum 6 years after surgery in SLN group, 4 years in Control group).
      Other imaging studies will be done only if clinically indicated. Any postoperative
      complication or disease recurrence will be managed according to the institutional guidelines.

      Outcomes after fertility sparing procedures in selected centres with be collected (i.e.
      morbidity after cervical procedure or ovarian transposition, treatment of infertility,
      pregnancy rates and complications).
    

Intervention name(s): Sentinel lymph node biopsy; At least unilateral systematic pelvic lymph node dissection
Intervention type(s): Procedure; Procedure
Intervention description(s): Bilateral sentinel lymph node biopsy, pathologic ultrastaging
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with early stages cervical cancer
      
Keywords: cervical cancer; sentinel lymph node; lymphadenectomy