Locally Advanced Cervical CancerNCT06759480
Study of Laparoscopic Radical Hysterectomy Based on Space Anatomy in Patients With IB3 and IIA2 Cervical Cancer
An observational study of Locally Advanced Cervical Cancer, run by International Peace Maternity and Child Health Hospital.
Trial summary
Radical hysterectomy is an effect treatment for FIGO IB3 and IIA2 cervical cancer patients who refuse to receive radical concurrent chemoradiotherapy. However, due to the large tumor size, both patients and surgeons encountered the risk of substantial bleeding, urinary tract damage, and unsatisfactory resection during… Read more about this study
- Who is it for?
- Ages 20 to 70 years, women only
- Conditions the study is for
- Locally Advanced Cervical Cancer
- What is being tested?
- Laparoscopic radical hysterectomy based on space anatomy and Abdominal radical hysterectomy
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 27 Dec 2024to 15 Mar 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 20 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients who clinically diagnosed with IB3 and IIA2 cervical cancer are retrospectively collected from electronic medical records of four tertiary medical center from January 2012 to January 2022
Who may be able to join
- Aged between 20 to 70 years
- Preoperative clinical diagnosis was FIGO 2018 stage IB3 or IIA2 cervical cancer;
- Patients who received standard Querleu-Morrow type C radical hysterectomy (including ARH or LRH based on space anatomy) and pelvic lymphadenectomy;
- no preoperative suspected lymph nodes metastasis, parametrial involvement or lower 1/3 vagina involvement.
Who cannot join
- patients who had active double cancer or uncontrolled serious concurrent disease that might compromise prognosis;
- pregnancy;
- incomplete radical surgery;
- follow-up time less than 6 months or lost to follow-up
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparison Between Laparoscopic Radical Hysterectomy Based on Space Anatomy and Abdominal Radical Hysterectomy for Stage IB3 and IIA2 Cervical Cancer: a Multicenter Retrospective Cohort Study
Radical hysterectomy is an effect treatment for FIGO IB3 and IIA2 cervical cancer patients who refuse to receive radical concurrent chemoradiotherapy. However, due to the large tumor size, both patients and surgeons encountered the risk of substantial bleeding, urinary tract damage, and unsatisfactory resection during surgery. Therefore, the exploration of effective and safe surgical treatments is crucial in enhancing the quality of life and prognosis for patients. Laparoscopic radical hysterectomy (LRH) offers the advantages of reduced bleeding and accelerated recovery, thereby minimizing patient discomfort and enhancing their quality of life. However, the prognosis of patients who received LRH or traditional abdominal radical hysterectomy (ARH) remains controversial. We proposed a modified LRH skill based on new space anatomy concept. In our previous single-center study, the result demonstrates that LRH based on space anatomy leads to less intraoperative blood loss and decreased ureteral injury rate compared with traditional skill. The benefits of this new method for patient survival remain uncertain. In this multicenter retrospective study, we aim to assess clinical prognosis and safety of this new LRH compared with traditional abdominal radical hysterectomy (ARH) in FIGO IB3 and IIA2 cervical cancer.
- Conditions
- Locally Advanced Cervical Cancer
- Being tested
- Laparoscopic radical hysterectomy based on space anatomy, Abdominal radical hysterectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic radical hysterectomy based on space anatomyProcedure or surgery
This is a modified laparoscopic radical hysterectomy based on space anatomy. By identifying the vesicouterine ligament and four associated special spaces, the ureter can be completely liberated from the external aspect of the uterus. This skill not only reduces rate of surgical complications but also facilitates optimal tumor resection.
Abdominal radical hysterectomyProcedure or surgery
This producre is a classic and traditional radical hysterectomy.
| Study group | Role | What they receive |
|---|---|---|
| LRH group | In this group, patients received a modified laparoscopic radical hysterectomy(LRH) based on space antomy. Receives: Procedure: Laparoscopic radical hysterectomy based on space anatomy | |
| ARH group | In this group, patients received a traditional abdominal radical hysterectomy(ARH). ARH group is defined as a control group. Receives: Procedure: Abdominal radical hysterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
The time from end of surgery to death from any cause.
Measured: 5 years
Progression-free survival
The time from end of surgery to either the first documented disease progression or death from any cause.
Measured: 5 years
Secondary outcomes (2)
Surgery complication rate
Including the rates of ureter or bladder injury, colon injury, deep vein thrombosis event and infection.
Measured: Intraoperative or within 2 weeks after surgery
Intraoperative blood loss
Measured: Intraoperative blood loss
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2025
- Study start27 Dec 2024 (estimated)
- Primary completion15 Jan 2025 (estimated)
- Study completion15 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Cervical CancerStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Peace Maternity and Child Health Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06759480
- Sponsor's protocol ID
- GKLW-A-2024-111-01
- Status last verified
- Dec 2024
- First submitted
- 28 Dec 2024
- Last updated
- 6 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Laparoscopic Radical Hysterectomy Based on Space Anatomy and Abdominal Radical Hysterectomy for Stage IB3 and IIA2 Cervical Cancer: a Multicenter Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT06759480
- Acronym / sponsor ID
- GKLW-A-2024-111-01
- Conditions
- Locally Advanced Cervical Cancer
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- International Peace Maternity and Child Health HospitalUniversity, hospital or other
- Study start
- 27 Dec 2024 (estimated)
- Primary completion
- 15 Jan 2025 (estimated)
- Study completion
- 15 Mar 2025 (estimated)
- First posted
- 6 Jan 2025 (actual)
- 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.
Radical hysterectomy is an effect treatment for FIGO IB3 and IIA2 cervical cancer patients who refuse to receive radical concurrent chemoradiotherapy. However, due to the large tumor size, both patients and surgeons encountered the risk of substantial bleeding, urinary tract damage, and unsatisfactory resection during surgery. Therefore, the exploration of effective and safe surgical treatments is crucial in enhancing the quality of life and prognosis for patients. Laparoscopic radical hysterectomy (LRH) offers the advantages of reduced bleeding and accelerated recovery, thereby minimizing patient discomfort and enhancing their quality of life. However, the prognosis of patients who received LRH or traditional abdominal radical hysterectomy (ARH) remains controversial. We proposed a modified LRH skill based on new space anatomy concept. In our previous single-center study, the result demonstrates that LRH based on space anatomy leads to less intraoperative blood loss and decreased ureteral injury rate compared with traditional skill. The benefits of this new method for patient survival remain uncertain. In this multicenter retrospective study, we aim to assess clinical prognosis and safety of this new LRH compared with traditional abdominal radical hysterectomy (ARH) in FIGO IB3 and IIA2 cervical cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LRH group | – | Procedure: Laparoscopic radical hysterectomy based on space anatomyIn this group, patients received a modified laparoscopic radical hysterectomy(LRH) based on space antomy. |
| ARH group | – | Procedure: Abdominal radical hysterectomyIn this group, patients received a traditional abdominal radical hysterectomy(ARH). ARH group is defined as a control group. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who clinically diagnosed with IB3 and IIA2 cervical cancer are retrospectively collected from electronic medical records of four tertiary medical center from January 2012 to January 2022
Key inclusion criteria (4 listed)
- Aged between 20 to 70 years
- Preoperative clinical diagnosis was FIGO 2018 stage IB3 or IIA2 cervical cancer;
- Patients who received standard Querleu-Morrow type C radical hysterectomy (including ARH or LRH based on space anatomy) and pelvic lymphadenectomy;
- no preoperative suspected lymph nodes metastasis, parametrial involvement or lower 1/3 vagina involvement.
Key exclusion criteria (4 listed)
- patients who had active double cancer or uncontrolled serious concurrent disease that might compromise prognosis;
- pregnancy;
- incomplete radical surgery;
- follow-up time less than 6 months or lost to follow-up
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 |
|---|---|---|
| Laparoscopic radical hysterectomy based on space anatomyThis is a modified laparoscopic radical hysterectomy based on space anatomy. By identifying the vesicouterine ligament and four associated special spaces, the ureter can be completely liberated from the external aspect of the uterus. This skill not only reduces rate of surgical complications but also facilitates optimal tumor resection. | Procedure or surgery | LRH group |
| Abdominal radical hysterectomyThis producre is a classic and traditional radical hysterectomy. | Procedure or surgery | ARH group |
Primary outcome
Overall survival
Time frame: 5 years
The time from end of surgery to death from any cause.
Progression-free survival
Time frame: 5 years
The time from end of surgery to either the first documented disease progression or death from any cause.
2 secondary outcomes
Surgery complication rate
Time frame: Intraoperative or within 2 weeks after surgery
Intraoperative blood loss
Time frame: Intraoperative blood loss
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Locally Advanced 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
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 3
Induction Pembrolizumab and Chemotherapy Followed by Pembrolizumab Before Chemoradiation and Pembrolizumab Maintenance Compared to Standard Chemoradiation With Pembrolizumab Followed by Pembrolizumab Maintenance in High-Risk Cervical Cancer
Locally Advanced Cervical Adenocarcinoma, Locally Advanced Cervical Adenosquamous Carcinoma
Not yet recruitingPhase 1/2
Intravenously Administered PROMITIL Combined With Radiotherapy in Patients With Cisplatin-Ineligible Head and Neck Cancer Patients
Head & Neck Squamous Cell Carcinoma, Locally Advanced Head and Neck Squamous Cell Carcinoma
Active, not recruitingPhase 2
Soylent in Reducing Gastrostomy Tube Rates in Patients With Locally Advanced Head and Neck Cancer Undergoing Chemoradiotherapy
Locally Advanced Head and Neck Carcinoma
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Locally Advanced Cervical Cancer, run by International Peace Maternity and Child Health Hospital.
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 4 inclusion and 4 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: opening soon, as of the sponsor's last update on 6 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sibang Chen (+86 18721757863, sibang_chen@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 5 years). 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?
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 6 Jan 2025.