Health Condition 1: C539- Malignant neoplasm of cervix uteri, unspecified Health Condition 2: C00-D49- Neoplasms
Conditions
Interventions
Intervention1: SLN dissection only: A full lymphadenectomy
will not be performed. The radical hysterectomy or trachelectomy will be
done
Control Intervention1: SLN and PLN dissection: A full lymphaden
Sponsors
Centre Hospitalier Universitaire de Besanon
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patient must be � 18 years old. 2. With squamous or adenocarcinoma of the cervix (proven by biopsy or cone biopsy) 3. Stage Ia1 with lymphovascular emboli, Ia2, Ib1, Ib2 and IIa1, (clinical stage) of the 2018 FIGO classification. 4. Maximum diameter � 40 mm by clinical examination and/or magnetic resonance imaging (MRI) 5. No suspicious on pelvic MRI with an exploration up to the left renal vein 6. ECOG performance status 0-2 7. Signed informed consent and ability to comply with follow-up
Exclusion criteria
Exclusion criteria: 1. Pregnancy, 2. Previous pelvic or abdominal cancer, 3. Previous chemotherapy and/or radiation therapy for cervical cancer (previous brachytherapy is accepted), 4. Proven allergy to blue dye, isotope or indocyanine green (ICG) 5.Other malignancy within the last 5 years except for treated cancer-free of disease and treatment, 6.Patients with synchronous cancer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DFS defined as the time interval between randomization and recurrence (local/distant) or second cancer or death (all causes) HR-QoL of patients assessed with EORTC QLQC 30 and QLQ-CX24 with 3 targeted dimensions: pain, global health score and physical functioning scores at 3 years.Timepoint: 3 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome of pN1 patients according to the size of metastasis and treatment; Evaluation of mapping with indocyanine green (ICG); Surgical morbidity and mortality; Other dimensions of HR-QoL; Positive and negative predictive values of SLN biopsy; Overall survival (OS); Recurrence free survival (RFS); A cost analysis will be performed; Lymphatic and lower limb complications Timepoint: At 3 years | — |
Countries
France, India
Contacts
Public ContactMou Dasgupta
Chittaranjan National Cancer Institute
Outcome results
None listed