Cervical CancerNCT01886508
A Multicentre Trial of Nerve-Spring Radical Hysterectomy vs. Radical Hysterectomy for Cervical Cancer
A study testing Nerve-spring radical hysterectomy and radical hysterectomy in people with Cervical Cancer, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 17 to 60 years, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Nerve-spring radical hysterectomy and radical hysterectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- Jul 2013to Dec 2020
- Phase
- Interventional
- 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 17 to 60 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
- Possible to radical hysterectomy or nerve-spring radical hysterectomy
- Age: 17 to 60 years
- No complication during operation
- Written informed consent
Who cannot join
- patients who underwent radiotherapy
- Pathologically diagnosed Pathologically diagnosed squamous carcinoma, Small Cell Carcinoma, Small Cell Carcinoma
- Patients who have uncontrolled diabetes or uncontrolled hypertension
- patients with neurogenic bladder dysfunction
- patients with uterine prolapse
- Patients with psychiatric illness
Show all 9Show fewer
- Patients who have active infection
- Patients who have had heart failure, unstable angina, or myocardial infarction within the past 6 months
- Patients who are unable to undergo radical hysterectomy for complication of excessive obesity, liver cirrhosis, or bleeding tendency
Trial locations and contacts
1 site in 1 country.
China1 site
Southern Medical University, China
Guangzhou, Guangdong, 510515
Chunlin Chen, M.D.,Ph.D., chenchunlinrct@163.com
Chenlin Chen, M.D.,Ph.D.
About this study
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.
- Conditions
- Cervical Cancer
- Being tested
- Nerve-spring radical hysterectomy, radical hysterectomy
- 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-spring radical hysterectomyProcedure or surgery
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.
radical hysterectomyProcedure or surgery
Radical hysterectomy is Piver III hysterectomy and Q-M classification Type C1 hysterectomy.
| Study group | Role | What they receive |
|---|---|---|
| NSRH | Experimental | patients in Arm NSRH undergo nerve-spring radical hysterectomy (NSRH) Receives: Procedure: Nerve-spring radical hysterectomy |
| RH | Active comparator | patients in Arm RH undergo radical hysterectomy (RH) Receives: Procedure: radical hysterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
maximum flow rate measured by Urodynamic at 6 months postoperative
Measured: on 6 months postoperative
residual volume measured by Urodynamic at 6 months postoperative
Measured: on 6 months postoperative
maximum vesical compliace measured by Urodynamic at 6 months postoperative
Measured: on 6 months postoperative
cystometric capacity at first desire measured by Urodynamic at 6 months postoperative
Measured: on 6 months postoperative
maximum cystometric capacity (MCC) measured by Urodynamic at 6 months postoperative
Measured: on 6 months postoperative
Secondary outcomes (9)
Time (days) to residual urine volume less than 100ml postoperative
Measured: from operation to residual urine volume less than 100ml, assessed up to 30 days
time (hours) to break wind postoperative
Measured: from operation to have the first break wind, assessed up to 72 hours
time (hours) to defecation postoperative
Measured: from operation to have the first defection, assessed up to 72 hours
Number of participants with adverse events
Measured: 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
Measured: on 6 months postoperative
overall survival
Measured: From date of operation until the date of death from any cause, assessed up to 5 years
progression-free survival
Measured: 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
Measured: on 6 months postoperative
Score of CX-24 life quality rating scales at 6 months postoperative
Measured: on 6 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2013 (estimated)
- Study startJul 2013
- Primary completionDec 2017 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Tumor Hospital of Xin Jiang Medical University,China, Gui Yang Maternal and Child Health Hospital,China, 152nd Hospital of Chinese People's Liberation Army
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01886508
- Sponsor's protocol ID
- NCT00270426
- Status last verified
- May 2013
- First submitted
- 25 Sep 2012
- Last updated
- 22 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre Trial of Nerve-Spring Radical Hysterectomy vs. Radical Hysterectomy for Cervical Cancer
- ClinicalTrials.gov ID
- NCT01886508
- Acronym / sponsor ID
- NCT00270426
- Conditions
- Cervical Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Collaborators
- Tumor Hospital of Xin Jiang Medical University,China, Gui Yang Maternal and Child Health Hospital,China, 152nd Hospital of Chinese People's Liberation Army
- Study start
- Jul 2013
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 26 Jun 2013 (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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NSRH | Experimental | Procedure: Nerve-spring radical hysterectomypatients in Arm NSRH undergo nerve-spring radical hysterectomy (NSRH) |
| RH | Active comparator | Procedure: radical hysterectomypatients in Arm RH undergo radical hysterectomy (RH) |
Who may qualify
- Ages
- 17 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
- Possible to radical hysterectomy or nerve-spring radical hysterectomy
- Age: 17 to 60 years
- No complication during operation
- Written informed consent
Key exclusion criteria (9 listed)
- patients who underwent radiotherapy
- Pathologically diagnosed Pathologically diagnosed squamous carcinoma, Small Cell Carcinoma, Small Cell Carcinoma
- Patients who have uncontrolled diabetes or uncontrolled hypertension
- patients with neurogenic bladder dysfunction
- patients with uterine prolapse
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-spring radical hysterectomyNerve-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. | Procedure or surgery | NSRH |
| radical hysterectomyRadical hysterectomy is Piver III hysterectomy and Q-M classification Type C1 hysterectomy. | Procedure or surgery | RH |
Primary outcome
maximum flow rate measured by Urodynamic at 6 months postoperative
Time frame: on 6 months postoperative
residual volume measured by Urodynamic at 6 months postoperative
Time frame: on 6 months postoperative
maximum vesical compliace measured by Urodynamic at 6 months postoperative
Time frame: on 6 months postoperative
cystometric capacity at first desire measured by Urodynamic at 6 months postoperative
Time frame: on 6 months postoperative
maximum cystometric capacity (MCC) measured by Urodynamic at 6 months postoperative
Time frame: on 6 months postoperative
9 secondary outcomes
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
time (hours) to break wind postoperative
Time frame: 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
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
Score of MHU rating scales at 6 months postoperative
Time frame: 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
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
Score of C-30 life quality rating scales at 6 months postoperative
Time frame: on 6 months postoperative
Score of CX-24 life quality rating scales at 6 months postoperative
Time frame: on 6 months postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2013.
Related trials for Cervical Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
Head & Neck Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nerve-spring radical hysterectomy and radical hysterectomy in people with Cervical Cancer, run by Nanfang Hospital, Southern Medical University 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 5 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 22 Jul 2013. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chenlin Chen, M.D.,Ph.D. (+8602062787947, chenchunlinrct@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
maximum flow rate measured by Urodynamic at 6 months postoperative (time frame: on 6 months postoperative). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jul 2013.