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

Cervical Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02368574
• Other study ID #: CGOG-001
• Status: Not yet recruiting
• Phase: N/A
• First received: January 18, 2015
• Last updated: February 15, 2015
• Start date: March 2015
• Est. completion date: December 2018

Study information

• Verified date: February 2015
• Source: Chinese Gynecological Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Science and Technology
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Procedure:
• Class II hysterectomy
Class II hysterectomy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Gynecological Oncology Group

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3-year disease-free survival (DFS) rate		up to 4 years	No
Secondary	Treatment-related toxicity		up to 4 years	Yes
Secondary	Post-operation quality of life		up to 4 years	No
Secondary	Cost effective		up to 4 years	No
Secondary	Pelvic and/or extra-pelvic relapse rate		up to 4 years	No
Secondary	Overall survival		up to 4 years	No
Secondary	Node number involved in retroperitoneal node dissection		up to 4 years	No
Secondary	Rates of parametrial, margins and pelvic/para-aortic nodes involvement		up to 4 years	No