Complete Nerve-Sparing Radical Hysterectomy for Cervical Cancer

Cervical Adenocarcinoma Clinical Trial

Official title:

A Simplified Approach of Complete Nerve-sparing Type C1 Radical Hysterectomy for Cervical Cancer, a Phase II Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02562729
• Other study ID #: zsfdu-obgyn-003
• Status: Completed
• Phase: Phase 2
• First received: September 18, 2015
• Last updated: October 12, 2016
• Start date: September 2015
• Est. completion date: September 2016

Study information

• Verified date: July 2016
• Source: Shanghai Gynecologic Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the feasibility of complete nerve-sparing type C1 radical hysterectomy in cervical cancer.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Carcinoma, Squamous Cell
• Cervical Adenocarcinoma
• Cervical Squamous Cell Carcinoma
• Malignant Neoplasm of Cervix Stage IB1
• Neoplasms
• Stage IIA1 Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Procedure:
• Nerve-Sparing Radical Hysterectomy
Type C1 NSRH Removal indwelling catheter on day 4 after surgery

Locations

Country	Name	City	State
China	Fudan University Shanghai Zhongshan Hospital	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai Gynecologic Oncology Group	Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	up to 30 days	No
Primary	Proportion of patients removing indwelling catheter		up to 30 days	No
Secondary	The rate of 36-month local control		up to 36 months	Yes