Comparison of Class II and Class III Hysterectomy in Early Stage Cervical Cancer Cervical Cancer

Chinese Gynecological Oncology Group500 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

500

Conditions

Cervical Cancer

Interventions

Class II hysterectomyPROCEDURE

Class II hysterectomy

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 55 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

3-year disease-free survival (DFS) rate

Time frame: up to 4 years

Secondary Outcomes

Treatment-related toxicity

Time frame: up to 4 years

Post-operation quality of life

Time frame: up to 4 years

Cost effective

Time frame: up to 4 years

Pelvic and/or extra-pelvic relapse rate

Time frame: up to 4 years

Overall survival

Time frame: up to 4 years

Node number involved in retroperitoneal node dissection

Time frame: up to 4 years

Rates of parametrial, margins and pelvic/para-aortic nodes involvement

Time frame: up to 4 years

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.