Back to resultsComplete Nerve-Sparing Radical Hysterectomy for Cervical Cancer
Primary Purpose
Cervical Squamous Cell Carcinoma, Cervical Adenocarcinoma, Malignant Neoplasm of Cervix Stage IB1
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Nerve-Sparing Radical Hysterectomy
Sponsored by
About this trial
This is an interventional treatment trial for Cervical Squamous Cell Carcinoma focused on measuring Cervical cancer; Nerve-sparing hysterectomy; simplified
Eligibility Criteria
Inclusion Criteria:
- Age >=18 years to <= 70 years.
- Women with histologically confirmed, primary adenocarcinoma or squamous cell carcinoma of the uterine cervix.
- Stage IIA1, or IB1 disease.
- Karnofsky performance status >70.
- Patients who comply with follow-up.
- With written informed consent.
Exclusion Criteria:
- Age>70
- History of lower urinary tract damage or surgery.
- With abnormal urodynamic study results.
- Karnofsky performance status <70.
- Patients who have uncontrolled psychological disorders.
- Unwilling to or unable to comply with protocol.
- Prior treatment with pelvic radiotherapy
Sites / Locations
- Fudan University Shanghai Zhongshan Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Nerve-Sparing Radical Hysterectomy (NSRH)
Arm Description
Type C1 Hysterectomy
Outcomes
Primary Outcome Measures
Proportion of patients with fully pelvic nerve plexus preserved
Proportion of patients who had a postvoid residual urine volume (PVR) under 50ml at postoperative day 4
Proportion of patients removing indwelling catheter
Secondary Outcome Measures
The rate of 36-month local control
Full Information
NCT ID
NCT02562729
First Posted
September 18, 2015
Last Updated
October 12, 2016
Sponsor
Shanghai Gynecologic Oncology Group
Collaborators
Fudan University
1. Study Identification
Unique Protocol Identification Number
NCT02562729
Brief Title
Complete Nerve-Sparing Radical Hysterectomy for Cervical Cancer
Official Title
A Simplified Approach of Complete Nerve-sparing Type C1 Radical Hysterectomy for Cervical Cancer, a Phase II Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Gynecologic Oncology Group
Collaborators
Fudan University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the feasibility of complete nerve-sparing type C1 radical hysterectomy in cervical cancer.
Detailed Description
The primary objective of this study is to evaluate the rate of postvoid residual urine volume (PVR) <50ml on postoperative day 4 in patients with stage IB1 and IIA1 cervix cancer underwent complete nerve-sparing type C1 radical hysterectomy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Squamous Cell Carcinoma, Cervical Adenocarcinoma, Malignant Neoplasm of Cervix Stage IB1, Stage IIA1 Cervical Cancer
Keywords
Cervical cancer; Nerve-sparing hysterectomy; simplified
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nerve-Sparing Radical Hysterectomy (NSRH)
Arm Type
Experimental
Arm Description
Type C1 Hysterectomy
Intervention Type
Procedure
Intervention Name(s)
Nerve-Sparing Radical Hysterectomy
Other Intervention Name(s)
Fully Pelvic-Nerve Plexus Preserved
Intervention Description
Type C1 NSRH Removal indwelling catheter on day 4 after surgery
Primary Outcome Measure Information:
Title
Proportion of patients with fully pelvic nerve plexus preserved
Description
Proportion of patients who had a postvoid residual urine volume (PVR) under 50ml at postoperative day 4
Time Frame
up to 30 days
Title
Proportion of patients removing indwelling catheter
Time Frame
up to 30 days
Secondary Outcome Measure Information:
Title
The rate of 36-month local control
Time Frame
up to 36 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age >=18 years to <= 70 years.
Women with histologically confirmed, primary adenocarcinoma or squamous cell carcinoma of the uterine cervix.
Stage IIA1, or IB1 disease.
Karnofsky performance status >70.
Patients who comply with follow-up.
With written informed consent.
Exclusion Criteria:
Age>70
History of lower urinary tract damage or surgery.
With abnormal urodynamic study results.
Karnofsky performance status <70.
Patients who have uncontrolled psychological disorders.
Unwilling to or unable to comply with protocol.
Prior treatment with pelvic radiotherapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rongyu Zang, MD,PhD
Organizational Affiliation
Fudan University Shanghai Zhongshan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fudan University Shanghai Zhongshan Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
29163840
Citation
Zhang Y, Shi T, Yin S, Ma S, Shi D, Guan J, Xiang L, Liu Y, Ren Y, Tan D, Zang R. An improved nerve-sparing radical hysterectomy technique for cervical cancer using the paravesico-vaginal space as a new surgical landmark. Oncotarget. 2017 Jul 5;8(52):90413-90420. doi: 10.18632/oncotarget.19011. eCollection 2017 Oct 27.
Results Reference
derived
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Complete Nerve-Sparing Radical Hysterectomy for Cervical Cancer
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