A Multicentre Trial of Nerve-Spring Radical Hysterectomy vs. Radical Hysterectomy for Cervical Cancer

July 19, 2013 updated by: Nanfang Hospital of Southern Medical University
The investigators designed this multicentre randomized study to investigate the clinical benefits of nerve-spring radical hysterectomy for cervical cancer. Patients with FIGO stage Ia2, Ib1, IIa1 and FIGO stage Ib2, IIa2 after neoadjuvant chemotherapy are randomized to either nerve-spring radical hysterectomy or radical hysterectomy. The primary endpoint are urodynamic outcome including maximum flow rate, residual volume, maximum vesical compliace, cystomctric capacity at first desire, and maximum cystomctric capacity. A total 240 patients (120 per treatment arm) are planned to accrue for this study within 7 years.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
240

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510515
        • Southern Medical University, China

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

17 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. FIGO(2009) stage Ia2, Ib1, and IIa1 Untreated cervical cancer OR FIGO(2009) stage Ib2 and IIa2 cervical cancer that possible to surgery after neoadjuvant chemotherapy
  2. Possible to radical hysterectomy or nerve-spring radical hysterectomy
  3. Age: 17 to 60 years
  4. No complication during operation
  5. Written informed consent

Exclusion Criteria:

  1. patients who underwent radiotherapy
  2. Pathologically diagnosed Pathologically diagnosed squamous carcinoma, Small Cell Carcinoma, Small Cell Carcinoma
  3. Patients who have uncontrolled diabetes or uncontrolled hypertension
  4. patients with neurogenic bladder dysfunction
  5. patients with uterine prolapse
  6. Patients with psychiatric illness
  7. Patients who have active infection
  8. Patients who have had heart failure, unstable angina, or myocardial infarction within the past 6 months
  9. Patients who are unable to undergo radical hysterectomy for complication of excessive obesity, liver cirrhosis, or bleeding tendency

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: NSRH
patients in Arm NSRH undergo nerve-spring radical hysterectomy (NSRH)
Procedure: Nerve-spring radical hysterectomy
Nerve-spring radical hysterectomy that is reserve some pelvic autonomic nerves during radical hysterectomy. Reserve hypogastric nerve trunk during dissecting cardinal ligament. Reserve pelvic splanchnic nerve trunk during exsecting uterosacral ligament. Reserve bladder nerve of pelvic plexus during dissecting vesicouterine ligament.
Active Comparator: RH
patients in Arm RH undergo radical hysterectomy (RH)
Procedure: radical hysterectomy
Radical hysterectomy is Piver III hysterectomy and Q-M classification Type C1 hysterectomy.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
maximum flow rate measured by Urodynamic at 6 months postoperative
Time Frame: on 6 months postoperative
on 6 months postoperative
residual volume measured by Urodynamic at 6 months postoperative
Time Frame: on 6 months postoperative
on 6 months postoperative
maximum vesical compliace measured by Urodynamic at 6 months postoperative
Time Frame: on 6 months postoperative
on 6 months postoperative
cystometric capacity at first desire measured by Urodynamic at 6 months postoperative
Time Frame: on 6 months postoperative
on 6 months postoperative
maximum cystometric capacity (MCC) measured by Urodynamic at 6 months postoperative
Time Frame: on 6 months postoperative
on 6 months postoperative

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Time (days) to residual urine volume less than 100ml postoperative
Time Frame: from operation to residual urine volume less than 100ml, assessed up to 30 days
from operation to residual urine volume less than 100ml, assessed up to 30 days
time (hours) to break wind postoperative
Time Frame: from operation to have the first break wind, assessed up to 72 hours
from operation to have the first break wind, assessed up to 72 hours
time (hours) to defecation postoperative
Time Frame: from operation to have the first defection, assessed up to 72 hours
from operation to have the first defection, assessed up to 72 hours
Number of participants with adverse events
Time Frame: From date of operation until the date of first documented adverse event or date of death from any cause, whichever came first, assessed up to 5 years
From date of operation until the date of first documented adverse event or date of death from any cause, whichever came first, assessed up to 5 years
Score of MHU rating scales at 6 months postoperative
Time Frame: on 6 months postoperative
on 6 months postoperative
overall survival
Time Frame: From date of operation until the date of death from any cause, assessed up to 5 years
From date of operation until the date of death from any cause, assessed up to 5 years
progression-free survival
Time Frame: From date of operation until the date of relapse or date of death from any cause, whichever came first, assessed up to 5 years
From date of operation until the date of relapse or date of death from any cause, whichever came first, assessed up to 5 years
Score of C-30 life quality rating scales at 6 months postoperative
Time Frame: on 6 months postoperative
on 6 months postoperative
Score of CX-24 life quality rating scales at 6 months postoperative
Time Frame: on 6 months postoperative
on 6 months postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nanfang Hospital of Southern Medical University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Tumor Hospital of Xin Jiang Medical University,China
Gui Yang Maternal and Child Health Hospital,China
The 152nd Hospital of chinese People's Liberation Army

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2013

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2017

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 25, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 23, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 26, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 22, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 19, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NCT00270426

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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