Cervical Cancer
Conditions
Brief summary
Based on the value-based medicine, a randomized clinical trial was conducted to compare the role of class II and class III hysterectomy in patients with low risk early staged cervical cancer (defined as tumor lesions less than 2cm with less than 50% stromal invasion).
Detailed description
This is a 1:1 multi-center randomized trial with class II hysterectomy plus node dissection as the experimental arm, and class III hysterectomy plus pelvic node dissection as the control arm. Primary endpoints are: (1). 3-year diseases-free survival (DFS) rate; (2) the rates of treatment-related toxicity; (3) post-operation QoL (including sexual function) and (4) treatment costs. Secondary endpoints are：(1) the rates of pelvic and/or extra-pelvic relapse; (2) overall survival(OS) rate; (3) the numbers of retroperitoneal node dissection, and (4) the rates of parametrial, margins and pelvic/para-aortic nodes involvement.
Interventions
PROCEDUREClass II hysterectomy
Class II hysterectomy
Sponsors
Chinese Gynecological Oncology Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
1. Stage IA2 and small IB1 \<2 cm 2. Less than 50% stromal invasion based on MRI OR 10mm stromal invasion based on the pathology measurement of the LEEP/cone specimen 3. Squamous OR adenocarcinoma OR adenosquamous 4. Grade 1, 2 and 3 5. Lymph-vascular space invasion (LVSI): presence or absence 6. Diagnosis confirmed by LEEP/cone/cervical biopsy 7. Pelvic MRI in patients with involved cone/LEEP margins and those who had cervical biopsy only 8. Abdomino-pelvic CT scan in patients with negative LEEP-cone margins 9. No contraindications to surgery 10. No desire to preserve fertility 11. Informed consent
Exclusion criteria
1. High-risk histology types (clear cell, small cell etc) 2. Evidence of lymph node metastasis on preoperative imaging 3. Stage 1A1 4. Neo-adjuvant chemotherapy 5. Pregnancy 6. Desire to preserve fertility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-year disease-free survival (DFS) rate | up to 4 years |
Secondary
| Measure | Time frame |
|---|---|
| Post-operation quality of life | up to 4 years |
| Cost effective | up to 4 years |
| Pelvic and/or extra-pelvic relapse rate | up to 4 years |
| Treatment-related toxicity | up to 4 years |
| Node number involved in retroperitoneal node dissection | up to 4 years |
| Rates of parametrial, margins and pelvic/para-aortic nodes involvement | up to 4 years |
| Overall survival | up to 4 years |
Outcome results
None listed