Clinical trial NCT02368574: Comparison of Class II and Class III Hysterectomy in Early Stage Cervical Cancer Cervical Cancer
Official title: Comparison of Class II and Class III Hysterectomy in Early Stage Cervical Cancer Cervical Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cervical Cancer
Lead sponsor: Chinese Gynecological Oncology Group
Sponsor class: OTHER_GOV
First posted: 2015-02-23
Enrollment: 500
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: 3-year disease-free survival (DFS) rate
timeFrame: up to 4 years
Secondary outcomes:
measure: Treatment-related toxicity
timeFrame: up to 4 years
measure: Post-operation quality of life
timeFrame: up to 4 years
measure: Cost effective
timeFrame: up to 4 years
measure: Pelvic and/or extra-pelvic relapse rate
timeFrame: up to 4 years
measure: Overall survival
timeFrame: up to 4 years
measure: Node number involved in retroperitoneal node dissection
timeFrame: up to 4 years
measure: Rates of parametrial, margins and pelvic/para-aortic nodes involvement
timeFrame: up to 4 years
Other outcomes:
Locations:
Study officials:
References:
citation: Sun H, Cao D, Shen K, Yang J, Xiang Y, Feng F, Wu L, Zhang Z, Ling B, Song L. Piver Type II vs. Type III Hysterectomy in the Treatment of Early-Stage Cervical Cancer: Midterm Follow-up Results of a Randomized Controlled Trial. Front Oncol. 2018 Nov 28;8:568. doi: 10.3389/fonc.2018.00568. eCollection 2018.