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

NCT02368574 | Unknown DMC

• 1 other identifier: CGOG-001
• Study Type: interventional
• Target: 500
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Cervical Cancer

Outcome Measures

Primary Outcomes (1)

• 3-year disease-free survival (DFS) rate

  up to 4 years

Secondary Outcomes (7)

• 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

Study Arms (2)

Class III hysterectomy Arm

NO INTERVENTION

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.

Class II hysterectomy Arm

EXPERIMENTAL

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

Interventions

Class II hysterectomy PROCEDURE

Class II hysterectomy

Class II hysterectomy Arm

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese Gynecological Oncology Group: lead

Related Publications (1)

• 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.

  PMID: 30555800 DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2015
• First Posted: February 23, 2015
• Study Start: March 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: February 23, 2015

Record last verified: 2015-02