Cervical Squamous Cell CarcinomaPhase 2NCT02562729
Complete Nerve-Sparing Radical Hysterectomy for Cervical Cancer
A Phase 2 study testing Nerve-Sparing Radical Hysterectomy in people with Cervical Squamous Cell Carcinoma and Cervical Adenocarcinoma, run by Shanghai Gynecologic Oncology Group at 1 site in China.
Trial summary
The purpose of this study is to evaluate the feasibility of complete nerve-sparing type C1 radical hysterectomy in cervical cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Cervical Squamous Cell Carcinoma, Cervical Adenocarcinoma, Malignant Neoplasm of Cervix Stage IB1
- What is being tested?
- Nerve-Sparing Radical Hysterectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteChina
- Study dates
- Sep 2015to Sep 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Fudan University Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality, 200032
About this study
Official title: A Simplified Approach of Complete Nerve-sparing Type C1 Radical Hysterectomy for Cervical Cancer, a Phase II Study
The purpose of this study is to evaluate the feasibility of complete nerve-sparing type C1 radical hysterectomy in cervical cancer.
Read the 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.
- Conditions
- Cervical Squamous Cell Carcinoma, Cervical Adenocarcinoma, Malignant Neoplasm of Cervix Stage IB1, Stage IIA1 Cervical Cancer
- Being tested
- Nerve-Sparing Radical Hysterectomy
- Keywords
- Cervical cancer; Nerve-sparing hysterectomy; simplified
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nerve-Sparing Radical HysterectomyProcedure or surgery
Also called Fully Pelvic-Nerve Plexus Preserved
Type C1 NSRH Removal indwelling catheter on day 4 after surgery
| Study group | Role | What they receive |
|---|---|---|
| Nerve-Sparing Radical Hysterectomy (NSRH) | Experimental | Type C1 Hysterectomy Receives: Procedure: Nerve-Sparing Radical Hysterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 30 days
Proportion of patients removing indwelling catheter
Measured: up to 30 days
Secondary outcomes (1)
The rate of 36-month local control
Measured: up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical Squamous Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Gynecologic Oncology Group
- Sponsor type
- Other government
- Collaborators
- Fudan University
- Responsible party
- Sponsor
- Investigators
- Rongyu Zang, MD,PhD, Principal investigator, Fudan University Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02562729
- Sponsor's protocol ID
- zsfdu-obgyn-003
- Status last verified
- Jul 2016
- First submitted
- 18 Sep 2015
- Last updated
- 14 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 29163840
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Simplified Approach of Complete Nerve-sparing Type C1 Radical Hysterectomy for Cervical Cancer, a Phase II Study
- ClinicalTrials.gov ID
- NCT02562729
- Acronym / sponsor ID
- zsfdu-obgyn-003
- Conditions
- Cervical Squamous Cell Carcinoma, Cervical Adenocarcinoma, Malignant Neoplasm of Cervix Stage IB1, Stage IIA1 Cervical Cancer
- Keywords
- Cervical cancer; Nerve-sparing hysterectomy; simplified
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Shanghai Gynecologic Oncology GroupOther government
- Collaborators
- Fudan University
- Study start
- Sep 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 29 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nerve-Sparing Radical Hysterectomy (NSRH) | Experimental | Procedure: Nerve-Sparing Radical HysterectomyType C1 Hysterectomy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nerve-Sparing Radical HysterectomyAlso: Fully Pelvic-Nerve Plexus PreservedType C1 NSRH Removal indwelling catheter on day 4 after surgery | Procedure or surgery | Nerve-Sparing Radical Hysterectomy (NSRH) |
Primary outcome
Proportion of patients with fully pelvic nerve plexus preserved
Time frame: up to 30 days
Proportion of patients who had a postvoid residual urine volume (PVR) under 50ml at postoperative day 4
Proportion of patients removing indwelling catheter
Time frame: up to 30 days
1 secondary outcome
The rate of 36-month local control
Time frame: up to 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2016.
- Derived from this study: PubMed 29163840Zhang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rongyu Zang, MD,PhD principal investigator
Fudan University Shanghai Zhongshan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nerve-Sparing Radical Hysterectomy in people with Cervical Squamous Cell Carcinoma and Cervical Adenocarcinoma, run by Shanghai Gynecologic Oncology Group at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with fully pelvic nerve plexus preserved (time frame: up to 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02562729, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2016.