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Different Surgical Approaches in Patients of Early-stage Cervical Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03739944
Recruitment Status : Recruiting
First Posted : November 14, 2018
Last Update Posted : December 28, 2018
Sponsor:
Information provided by (Responsible Party):
Lei Li, Peking Union Medical College Hospital

Brief Summary:
This multi-center, randomized controlled study aims to compare the survival outcomes (including overall survival, progression-free survival and disease-free survival between Chinese uterine cervical patients receiving different surgical routes (laparotomy and laparoscopy) for radical hysterectomy or trachelectomy, which is the primary study objective. All patients with uterine cervical cancer of FIGO stage IA1 (with lymphovascular space invasion), IA2 and IB1 will be included and randomized into two groups: laparotomy and laparoscopy groups for radical hysterectomy or trachelectomy. Secondary study objectives include: patterns of recurrence, treatment-associated morbidity (6 months from surgery), cost-effectiveness, pelvic floor function, and quality of life.

Condition or disease Intervention/treatment Phase
Uterine Cervical Neoplasm Laparotomy Laparoscopy Survival Mortality Morbidity Quality of Life Pelvic Floor Disorders Cost-Benefit Analysis Procedure: Laparotomic radical hysterectomy Procedure: Laparotomic radical trachelectomy Procedure: Laparoscopic radical hysterectomy Procedure: Laparoscopic radical trachelectomy Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Randomized Trial of Different Surgical Approaches in Patients of Chinese Early-stage Cervical Cancer
Actual Study Start Date : November 23, 2018
Estimated Primary Completion Date : November 23, 2022
Estimated Study Completion Date : November 23, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Laparotomic radical hysterectomy Procedure: Laparotomic radical hysterectomy
Laparotomic radical hysterectomy for patients without fertility requirement

Active Comparator: Laparotomic radical trachelectomy Procedure: Laparotomic radical trachelectomy
Laparotomic radical hysterectomy for patients with fertility requirement

Active Comparator: Laparoscopic radical hysterectomy Procedure: Laparoscopic radical hysterectomy
Laparoscopic radical hysterectomy for patients without fertility requirement

Active Comparator: Laparoscopic radical trachelectomy Procedure: Laparoscopic radical trachelectomy
Laparoscopic radical hysterectomy for patients with fertility requirement




Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: Five years ]
    The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse.


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: Five years ]
    The length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive.

  2. Disease-free survival [ Time Frame: Five years ]
    In cancer, the length of time after primary treatment for a cancer ends that the patient survives without any signs or symptoms of that cancer.

  3. Morbidity rate [ Time Frame: Six months ]
    Refers to having a disease or a symptom of disease, or to the amount of disease within a population. In this study, morbidity of six months from the surgery is defined according to Common Terminology Criteria for Adverse Events (CTCAE) v4.03


Other Outcome Measures:
  1. Cost-effectiveness of different surgical routes [ Time Frame: One year ]
    The direct cost of different surgical routes

  2. Quality of life [ Time Frame: Three years ]
    The quality of life measured by academic questionnaire

  3. Sex function [ Time Frame: Five years ]
    Sex function measured by academic questionnaire before and after surgeries

  4. Urodynamics [ Time Frame: Five years ]
    Urinary functions are measured by dynamic tests before and after surgeries

  5. Rectal functions [ Time Frame: Five years ]
    Rectal functions are measured by dynamic tests before and after surgeries



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed primary adenocarcinoma, squamous cell carcinoma or adenosquamous carcinoma of the uterine cervix
  • FIGO stage IA1 (with lymphovascular space invasion), IA2 or IB1
  • Type II or III radical hysterectomy or trachelectomy
  • Performance status of ECOG 0-1
  • Aged 18 years or older
  • Signed an approved informed consents

Exclusion Criteria:

  • Not satisfying any of the inclusion criteria

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03739944


Contacts
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Contact: Lei Li, M.D. 13911988831 ext 86 lileigh@163.com

Locations
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China, Beijing
Lei Li Recruiting
Beijing, Beijing, China, 100730
Contact: Lei Li, MD    008613911988831    lileigh@163.com   
Sponsors and Collaborators
Lei Li

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Lei Li, Professor, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT03739944    
Other Study ID Numbers: RACC
First Posted: November 14, 2018    Key Record Dates
Last Update Posted: December 28, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The data will be available to all the researches via public websites.
Supporting Materials: Study Protocol
Clinical Study Report (CSR)
Time Frame: The data will be available once the papers were accepted and be available for ever

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Pelvic Floor Disorders
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Pregnancy Complications