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

Sponsor

Chinese Gynecological Oncology Group (Other)

Overall Status

Unknown status

CT.gov ID

NCT02368574

Collaborator

(none)

500

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Cervical Cancer	Procedure: Class II hysterectomy	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

500 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 2015

Anticipated Primary Completion Date :

Dec 1, 2018

Anticipated Study Completion Date :

Dec 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Class III hysterectomy Arm Class III hysterectomy (radical hysterectomy): This procedure may be performed through laparotomy or laparoscope. Perivesical space and perirectal space should be opened, and the ureteral tunnel is completely separated and pushed down to the junction of ureter and urinary bladder. The uterine arteries are ligated at the level of internal iliac artery, and all the supporting ligaments and connective tissues around the uterus should be separated and abscised. The uterosacral ligament is removed near the sacrum, the cardinal ligament is removed near the pelvic wall, and the vagina is removed after the excision of peivaginal connective tissues, about 3-4cm from the cervical lesion. The pelvic lymph nodes are usually dissected at the same time.
Experimental: Class II hysterectomy Arm Class II hysterectomy (modified radical hysterectomy): This procedure may be performed through laparotomy or laparoscope. The scope of surgery is more extensive than Class I epifascial panhysterectomy, demanding the excision of more parametrium but reservation of the blood supply for distal ureter and urinary bladder. The ureter is separated from the ureteral tunnel, the vesicouterine ligament should be intact, and 1/2 uterosacral ligament and 1cm vagina are excised. The pelvic lymph nodes are usually dissected at the same time.	Procedure: Class II hysterectomy Class II hysterectomy

Arm

Intervention/Treatment

No Intervention: Class III hysterectomy Arm

Class III hysterectomy (radical hysterectomy): This procedure may be performed through laparotomy or laparoscope. Perivesical space and perirectal space should be opened, and the ureteral tunnel is completely separated and pushed down to the junction of ureter and urinary bladder. The uterine arteries are ligated at the level of internal iliac artery, and all the supporting ligaments and connective tissues around the uterus should be separated and abscised. The uterosacral ligament is removed near the sacrum, the cardinal ligament is removed near the pelvic wall, and the vagina is removed after the excision of peivaginal connective tissues, about 3-4cm from the cervical lesion. The pelvic lymph nodes are usually dissected at the same time.

Experimental: Class II hysterectomy Arm

Class II hysterectomy (modified radical hysterectomy): This procedure may be performed through laparotomy or laparoscope. The scope of surgery is more extensive than Class I epifascial panhysterectomy, demanding the excision of more parametrium but reservation of the blood supply for distal ureter and urinary bladder. The ureter is separated from the ureteral tunnel, the vesicouterine ligament should be intact, and 1/2 uterosacral ligament and 1cm vagina are excised. The pelvic lymph nodes are usually dissected at the same time.

Procedure: Class II hysterectomy

Class II hysterectomy

Outcome Measures

Primary Outcome Measures

3-year disease-free survival (DFS) rate [up to 4 years]

Secondary Outcome Measures

Treatment-related toxicity [up to 4 years]
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]
Overall survival [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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 55 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Stage IA2 and small IB1 <2 cm
Less than 50% stromal invasion based on MRI OR 10mm stromal invasion based on the pathology measurement of the LEEP/cone specimen
Squamous OR adenocarcinoma OR adenosquamous
Grade 1, 2 and 3
Lymph-vascular space invasion (LVSI): presence or absence
Diagnosis confirmed by LEEP/cone/cervical biopsy
Pelvic MRI in patients with involved cone/LEEP margins and those who had cervical biopsy only
Abdomino-pelvic CT scan in patients with negative LEEP-cone margins
No contraindications to surgery
No desire to preserve fertility
Informed consent

Exclusion Criteria:

High-risk histology types (clear cell, small cell etc)
Evidence of lymph node metastasis on preoperative imaging
Stage 1A1
Neo-adjuvant chemotherapy
Pregnancy
Desire to preserve fertility

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Chinese Gynecological Oncology Group

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Chinese Gynecological Oncology Group

ClinicalTrials.gov Identifier:

NCT02368574

Other Study ID Numbers:

CGOG-001

First Posted:

Feb 23, 2015

Last Update Posted:

Feb 23, 2015

Last Verified:

Feb 1, 2015

Additional relevant MeSH terms:

Uterine Cervical Neoplasms

Study Results

No Results Posted as of Feb 23, 2015