Uterine Cervical NeoplasmPhase 3NCT03739944
Different Surgical Approaches in Patients of Early-stage Cervical Cancer
A Phase 3 study testing Laparotomic radical hysterectomy, Laparotomic radical trachelectomy and Laparoscopic radical hysterectomy in people with Uterine Cervical Neoplasm and Laparotomy, run by Lei Li at 1 site in China.
Trial summary
This multi-center, randomized controlled study aims to compare the survival outcomes (including overall survival, progression-free survival and disease-free survival between Chinese uterine cervical patients receiving different surgical routes (laparotomy and laparoscopy) for radical hysterectomy or trachelectomy… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Uterine Cervical Neoplasm, Laparotomy, Laparoscopy
- What is being tested?
- Laparotomic radical hysterectomy, Laparotomic radical trachelectomy and Laparoscopic radical hysterectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 1 siteChina
- Study dates
- 23 Nov 2018to 23 Nov 2023
- Phase
- Phase 3
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed primary adenocarcinoma, squamous cell carcinoma or adenosquamous carcinoma of the uterine cervix
- FIGO stage IA1 (with lymphovascular space invasion), IA2 or IB1
- Type II or III radical hysterectomy or trachelectomy
- Performance status of ECOG 0-1
- Aged 18 years or older
- Signed an approved informed consents
Who cannot join
- Not satisfying any of the inclusion criteria
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Lei Li
Beijing, Beijing Municipality, 100730
Lei Li, MD, 008613911988831, lileigh@163.com
About this study
Official title: Randomized Trial of Different Surgical Approaches in Patients of Chinese Early-stage Cervical Cancer
This multi-center, randomized controlled study aims to compare the survival outcomes (including overall survival, progression-free survival and disease-free survival between Chinese uterine cervical patients receiving different surgical routes (laparotomy and laparoscopy) for radical hysterectomy or trachelectomy, which is the primary study objective. All patients with uterine cervical cancer of FIGO stage IA1 (with lymphovascular space invasion), IA2 and IB1 will be included and randomized into two groups: laparotomy and laparoscopy groups for radical hysterectomy or trachelectomy. Secondary study objectives include: patterns of recurrence, treatment-associated morbidity (6 months from surgery), cost-effectiveness, pelvic floor function, and quality of life.
- Conditions
- Uterine Cervical Neoplasm, Laparotomy, Laparoscopy, Survival, Mortality, Morbidity
- Being tested
- Laparotomic radical hysterectomy, Laparotomic radical trachelectomy, Laparoscopic radical hysterectomy, Laparoscopic radical trachelectomy
- Medical subject headings
- Uterine Cervical Neoplasms, Pelvic Floor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparotomic radical hysterectomyProcedure or surgery
Laparotomic radical hysterectomy for patients without fertility requirement
Laparotomic radical trachelectomyProcedure or surgery
Laparotomic radical hysterectomy for patients with fertility requirement
Laparoscopic radical hysterectomyProcedure or surgery
Laparoscopic radical hysterectomy for patients without fertility requirement
Laparoscopic radical trachelectomyProcedure or surgery
Laparoscopic radical hysterectomy for patients with fertility requirement
| Study group | Role | What they receive |
|---|---|---|
| Laparotomic radical hysterectomy | Active comparator | Not described Receives: Procedure: Laparotomic radical hysterectomy |
| Laparotomic radical trachelectomy | Active comparator | Not described Receives: Procedure: Laparotomic radical trachelectomy |
| Laparoscopic radical hysterectomy | Active comparator | Not described Receives: Procedure: Laparoscopic radical hysterectomy |
| Laparoscopic radical trachelectomy | Active comparator | Not described Receives: Procedure: Laparoscopic radical trachelectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse.
Measured: Five years
Secondary outcomes (3)
Overall survival
The length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive.
Measured: Five years
Disease-free survival
In cancer, the length of time after primary treatment for a cancer ends that the patient survives without any signs or symptoms of that cancer.
Measured: Five years
Morbidity rate
Refers to having a disease or a symptom of disease, or to the amount of disease within a population. In this study, morbidity of six months from the surgery is defined according to Common Terminology Criteria for Adverse Events (CTCAE) v4.03
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2018
- Study start23 Nov 2018
- Primary completion23 Nov 2022 (estimated)
- Study completion23 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Uterine Cervical NeoplasmStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lei Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lei Li, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03739944
- Sponsor's protocol ID
- RACC
- Status last verified
- Dec 2018
- First submitted
- 8 Nov 2018
- Last updated
- 28 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available to all the researches via public websites.
Publications
Chao X, Li L, Wu M, Wu H, Ma S, Tan X, Zhong S, Lang J. Minimally invasive versus open radical trachelectomy for early-stage cervical cancer: protocol for a multicenter randomized controlled trial in China. Trials. 2020 Dec 14;21(1):1022. doi: 10.1186/s13063-020-04938-3.
PubMed 33317612Ferrandina G, Corrado G, Scambia G. Minimally invasive surgery and quality of life in cervical cancer. Lancet Oncol. 2020 Jun;21(6):746-748. doi: 10.1016/S1470-2045(20)30161-3. No abstract available.
PubMed 32502439Chao X, Li L, Wu M, Ma S, Tan X, Zhong S, Lang J, Cheng A, Li W. Efficacy of different surgical approaches in the clinical and survival outcomes of patients with early-stage cervical cancer: protocol of a phase III multicentre randomised controlled trial in China. BMJ Open. 2019 Jul 29;9(7):e029055. doi: 10.1136/bmjopen-2019-029055.
PubMed 31362966
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Different Surgical Approaches in Patients of Chinese Early-stage Cervical Cancer
- ClinicalTrials.gov ID
- NCT03739944
- Acronym / sponsor ID
- RACC
- Conditions
- Uterine Cervical Neoplasm, Laparotomy, Laparoscopy, Survival, Mortality, Morbidity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Lei LiUniversity, hospital or other
- Study start
- 23 Nov 2018 (actual)
- Primary completion
- 23 Nov 2022 (estimated)
- Study completion
- 23 Nov 2023 (estimated)
- First posted
- 14 Nov 2018 (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.
This multi-center, randomized controlled study aims to compare the survival outcomes (including overall survival, progression-free survival and disease-free survival between Chinese uterine cervical patients receiving different surgical routes (laparotomy and laparoscopy) for radical hysterectomy or trachelectomy, which is the primary study objective. All patients with uterine cervical cancer of FIGO stage IA1 (with lymphovascular space invasion), IA2 and IB1 will be included and randomized into two groups: laparotomy and laparoscopy groups for radical hysterectomy or trachelectomy. Secondary study objectives include: patterns of recurrence, treatment-associated morbidity (6 months from surgery), cost-effectiveness, pelvic floor function, and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Laparotomic radical hysterectomy | Active comparator | Procedure: Laparotomic radical hysterectomy |
| Laparotomic radical trachelectomy | Active comparator | Procedure: Laparotomic radical trachelectomy |
| Laparoscopic radical hysterectomy | Active comparator | Procedure: Laparoscopic radical hysterectomy |
| Laparoscopic radical trachelectomy | Active comparator | Procedure: Laparoscopic radical trachelectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Confirmed primary adenocarcinoma, squamous cell carcinoma or adenosquamous carcinoma of the uterine cervix
- FIGO stage IA1 (with lymphovascular space invasion), IA2 or IB1
- Type II or III radical hysterectomy or trachelectomy
- Performance status of ECOG 0-1
- Aged 18 years or older
Key exclusion criteria (1 listed)
- Not satisfying any of the inclusion criteria
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 |
|---|---|---|
| Laparotomic radical hysterectomyLaparotomic radical hysterectomy for patients without fertility requirement | Procedure or surgery | Laparotomic radical hysterectomy |
| Laparotomic radical trachelectomyLaparotomic radical hysterectomy for patients with fertility requirement | Procedure or surgery | Laparotomic radical trachelectomy |
| Laparoscopic radical hysterectomyLaparoscopic radical hysterectomy for patients without fertility requirement | Procedure or surgery | Laparoscopic radical hysterectomy |
| Laparoscopic radical trachelectomyLaparoscopic radical hysterectomy for patients with fertility requirement | Procedure or surgery | Laparoscopic radical trachelectomy |
Primary outcome
Progression-free survival
Time frame: Five years
The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse.
3 secondary outcomes
Overall survival
Time frame: Five years
Disease-free survival
Time frame: Five years
Morbidity rate
Time frame: Six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2018.
- Derived from this study: PubMed 33317612Chao X, Li L, Wu M, Wu H, Ma S, Tan X, Zhong S, Lang J. Minimally invasive versus open radical trachelectomy for early-stage cervical cancer: protocol for a multicenter randomized controlled trial in China. Trials. 2020 Dec 14;21(1):1022. doi: 10.1186/s13063-020-04938-3.
- Derived from this study: PubMed 32502439Ferrandina G, Corrado G, Scambia G. Minimally invasive surgery and quality of life in cervical cancer. Lancet Oncol. 2020 Jun;21(6):746-748. doi: 10.1016/S1470-2045(20)30161-3. No abstract available.
- Derived from this study: PubMed 31362966Chao X, Li L, Wu M, Ma S, Tan X, Zhong S, Lang J, Cheng A, Li W. Efficacy of different surgical approaches in the clinical and survival outcomes of patients with early-stage cervical cancer: protocol of a phase III multicentre randomised controlled trial in China. BMJ Open. 2019 Jul 29;9(7):e029055. doi: 10.1136/bmjopen-2019-029055.
- Individual participant dataSharing planned: Yes. The data will be available to all the researches via public websites.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Laparotomic radical hysterectomy, Laparotomic radical trachelectomy and Laparoscopic radical hysterectomy in people with Uterine Cervical Neoplasm and Laparotomy, run by Lei Li 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 1 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 28 Dec 2018. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Lei Li, M.D. (13911988831 ext. 86, lileigh@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: Five years). 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 NCT03739944, which also lists 3 linked publications.
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 28 Dec 2018.