Actively Recruiting

Phase Not Applicable
Age: 21Years - 70Years
FEMALE
NCT04939831

Laparoscopic or Abdominal Radical Hysterectomy for Cervical Cancer(Stage IB3,IIA2)

Led by Obstetrics & Gynecology Hospital of Fudan University · Updated on 2021-11-10

1104

Participants Needed

1

Research Sites

263 weeks

Total Duration

On this page

Sponsors

O

Obstetrics & Gynecology Hospital of Fudan University

Lead Sponsor

C

Children's Hospital of Fudan University

Collaborating Sponsor

AI-Summary

What this Trial Is About

The purpose of this study is to confirm whether there is a difference between laparoscopic radical hysterectomy (LRH) and abdominal radical hysterectomy (ARH) in patient survival for Cervical Cancer (Stage IB3, IIA2).

CONDITIONS

Official Title

Laparoscopic or Abdominal Radical Hysterectomy for Cervical Cancer(Stage IB3,IIA2)

Who Can Participate

Age: 21Years - 70Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Clinical diagnosis of squamous carcinoma of the cervix, adenocarcinoma, or squamous adenocarcinoma at Stage IB3 or IIA2
  • Age between 21 and 70 years
  • Eligible for surgery type B or C according to Q-M surgical staging
  • Normal liver and kidney function and blood counts within specified limits
  • Hemoglobin greater than 60 g/L
  • Platelet count greater than 70 x 10^9/L
  • Leukocyte count greater than 3 x 10^9/L
  • Creatinine less than 50 mg/dL
  • Transaminase levels not more than three times the upper normal limit
  • No history of other malignancies
  • Not pregnant
  • Karnofsky performance score of 60 or higher
  • Voluntary participation with signed informed consent and willingness to comply with follow-up
  • No psychiatric disorders or serious immune system disorders such as lupus erythematosus, myasthenia gravis, or HIV infection
Not Eligible

You will not qualify if you...

  • Contraindications for surgery that prevent undergoing the procedure
  • Prior pelvic or abdominal radiotherapy or neoadjuvant chemotherapy for cervical cancer
  • Recurrent cervical cancer
  • Imaging (CT, MRI, or PET-CT) showing suspicious pelvic lymph node metastasis with maximum diameter greater than 2 cm after preoperative evaluation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The Obstetrics and Gynecology Hospital of Fudan University

Shanghai, Shanghai Municipality, China, 200000

Actively Recruiting

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Research Team

H

Hua Jiang, PHD

CONTACT

X

Xin Wu, PHD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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