Cervical CancerSYSUGO-005NCT02624531
Prospective Study of Fertility-sparing Treatment Strategy in Patients With Early Cervical Cancer(SYSUGO-005/CSEM009)
A study testing Taxane and radical trachelectomy in people with Cervical Cancer, run by Sun Yat-sen University at 2 sites in China.
Trial summary
Patients with cervical cancer staging IB1-IIA2 desiring keeping their fertility function will be recruited. Before treatment, MRI scanning will be used to exclude retroperitoneal lymph node metastasis, involvement of lower part of uterus and endometrial carcinoma.If there is no macroscopic tumor and no obvious disease… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Taxane and radical trachelectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesChina
- Study dates
- Nov 2015to Nov 2025
- 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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- patients with cervical cancer staging IB1-IIA2 desiring keeping their fertility function
Who cannot join
- retroperitoneal lymph node metastasis, involvement of lower part of uterus and endometrial carcinoma
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Clinical Trial Center
Guangzhou, Guangdong, 510060
Jihong Liu, Ph.D., 86-20-87343102, Liujih@mail.sysu.edu.cn
Yanling Feng, Ph.D., 86-20-87343104, fengyl@sysucc.org.cn
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Jihong Liu, Ph.D., 86-20-87343102, Liujih@mail.sysu.edu.cn
Yanling Feng, Ph.D., 86-20-87343104, fengyl@sysucc.org.cn
About this study
Patients with cervical cancer staging IB1-IIA2 desiring keeping their fertility function will be recruited. Before treatment, MRI scanning will be used to exclude retroperitoneal lymph node metastasis, involvement of lower part of uterus and endometrial carcinoma.If there is no macroscopic tumor and no obvious disease in MRI,simple trachelectomy (ST) + sentinel lymph node biopsy (SLNB) / retroperitoneal lymph node dissection(RPLND) will be performed. Otherwise,two to three cycles of neoadjuvant chemotherapy (NACT) will be administrated and then different fertility-sparing surgery(conization,ST or radical trachelectomy(RT) + SLNB/RPLND) will be employed depending on the tumor size.
Read the detailed description
The age of patients who are diagnosed with cervical cancer has decreased, resulting in a trend of increasingly younger patients who seek to preserve their fertility. Therefore, a less radical approach that aims to preserve the potential for fertility during the treatment of cervical carcinoma is crucial. Herein, the investigators devote to exploring optimal fertility-sparing treatment strategy in Patients With cervical cancer.
In this study, patients with cervical cancer staging IB1-IIA2 desiring keeping their fertility function will be recruited. Before treatment, MRI scanning will be used to exclude retroperitoneal lymph node metastasis, involvement of lower part of uterus and endometrial carcinoma.
All lymph nodes and margin should be pathologic reviewed during the surgery. Fertility-sparing surgery should be abandoned if positive lymph node is found.
If there is no macroscopic tumor and no obvious disease in MRI, ST+ SLNB/RPLND will be performed. Otherwise, two or three cycles of NACT will be administrated and then chemotherapy response will be assessed with physical examination and MRI scanning.
If there is no obvious residual disease after NACT, the colposcopy will be used to search for the suspicious disease in the cervix and on the vaginal wall. If there is no disease on the vaginal wall, the conization and SLNB / RPLND is employed. If pathologic review finds no residual disease or the residual disease is more than 5 mm away from cone margin, the surgery procedure ceases; If pathologic review finds the residual disease is less than 5 mm away from cone margin, ST± upper vaginal margin resection is performed.
If the residual disease is less than 2cm in diameter, simple trachelectomy (ST) ± upper vaginal margin resection and SLNB/ RPLND is employed.
If the residual disease is greater than 2 cm and less than 4cm in diameter, radical trachelectomy (RT) and SLNB/ RPLND is employed.
If the residual disease is greater than 4 cm in diameter, fertility-sparing surgery should be abandoned.
Tow to three cycles of adjuvant chemotherapy will be administrated after the fertility-sparing surgery.
- Conditions
- Cervical Cancer
- Being tested
- Taxane, radical trachelectomy
- Keywords
- NACT, Cervical cancer, Fertility sparing, Pregnancy, Treatment Strategy
- 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.
TaxaneDrug
Also called cisplatin
NACT and Fertility-sparing Treatment Strategy
radical trachelectomyProcedure or surgery
Also called simple trachelectomy, conization, sentinel node biopsy
NACT and Fertility-sparing Treatment Strategy
| Study group | Role | What they receive |
|---|---|---|
| fertility-sparing surgery | Other | NACT with Taxane combined with cisplatin and Fertility-sparing Treatment Strategy Receives: Drug: Taxane; Procedure: radical trachelectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
pregnancy rate
Measured: 5 years
Secondary outcomes (1)
overall survival rate
Measured: 5years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2015 (estimated)
- Study startNov 2015
- Primary completionNov 2025 (estimated)
- Study completionNov 2025 (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 Sun Yat-sen 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jihong Liu, Sun Yat-sen University
- Investigators
- Jihong Liu, PhD, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02624531
- Sponsor's protocol ID
- 2015-FXY-070
- Acronym
- SYSUGO-005
- Status last verified
- Jan 2021
- First submitted
- 9 Nov 2015
- Last updated
- 7 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of Fertility-sparing Treatment Strategy in Patients With Early Cervical Cancer(SYSUGO-005/CSEM009)
- ClinicalTrials.gov ID
- NCT02624531
- Acronym / sponsor ID
- SYSUGO-005 / 2015-FXY-070
- Conditions
- Cervical Cancer
- Keywords
- NACT, Cervical cancer, Fertility sparing, Pregnancy, Treatment Strategy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 8 Dec 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.
Patients with cervical cancer staging IB1-IIA2 desiring keeping their fertility function will be recruited. Before treatment, MRI scanning will be used to exclude retroperitoneal lymph node metastasis, involvement of lower part of uterus and endometrial carcinoma.If there is no macroscopic tumor and no obvious disease in MRI,simple trachelectomy (ST) + sentinel lymph node biopsy (SLNB) / retroperitoneal lymph node dissection(RPLND) will be performed. Otherwise,two to three cycles of neoadjuvant chemotherapy (NACT) will be administrated and then different fertility-sparing surgery(conization,ST or radical trachelectomy(RT) + SLNB/RPLND) will be employed depending on the tumor size.
Detailed description
The age of patients who are diagnosed with cervical cancer has decreased, resulting in a trend of increasingly younger patients who seek to preserve their fertility. Therefore, a less radical approach that aims to preserve the potential for fertility during the treatment of cervical carcinoma is crucial. Herein, the investigators devote to exploring optimal fertility-sparing treatment strategy in Patients With cervical cancer.
In this study, patients with cervical cancer staging IB1-IIA2 desiring keeping their fertility function will be recruited. Before treatment, MRI scanning will be used to exclude retroperitoneal lymph node metastasis, involvement of lower part of uterus and endometrial carcinoma.
All lymph nodes and margin should be pathologic reviewed during the surgery. Fertility-sparing surgery should be abandoned if positive lymph node is found.
If there is no macroscopic tumor and no obvious disease in MRI, ST+ SLNB/RPLND will be performed. Otherwise, two or three cycles of NACT will be administrated and then chemotherapy response will be assessed with physical examination and MRI scanning.
If there is no obvious residual disease after NACT, the colposcopy will be used to search for the suspicious disease in the cervix and on the vaginal wall. If there is no disease on the vaginal wall, the conization and SLNB / RPLND is employed. If pathologic review finds no residual disease or the residual disease is more than 5 mm away from cone margin, the surgery procedure ceases; If pathologic review finds the residual disease is less than 5 mm away from cone margin, ST± upper vaginal margin resection is performed.
If the residual disease is less than 2cm in diameter, simple trachelectomy (ST) ± upper vaginal margin resection and SLNB/ RPLND is employed.
If the residual disease is greater than 2 cm and less than 4cm in diameter, radical trachelectomy (RT) and SLNB/ RPLND is employed.
If the residual disease is greater than 4 cm in diameter, fertility-sparing surgery should be abandoned.
Tow to three cycles of adjuvant chemotherapy will be administrated after the fertility-sparing surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| fertility-sparing surgery | Other | Drug: Taxane, Procedure: radical trachelectomyNACT with Taxane combined with cisplatin and Fertility-sparing Treatment Strategy |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- patients with cervical cancer staging IB1-IIA2 desiring keeping their fertility function
Key exclusion criteria (1 listed)
- retroperitoneal lymph node metastasis, involvement of lower part of uterus and endometrial carcinoma
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 |
|---|---|---|
| TaxaneAlso: cisplatinNACT and Fertility-sparing Treatment Strategy | Drug | fertility-sparing surgery |
| radical trachelectomyAlso: simple trachelectomy, conization, sentinel node biopsyNACT and Fertility-sparing Treatment Strategy | Procedure or surgery | fertility-sparing surgery |
Primary outcome
pregnancy rate
Time frame: 5 years
1 secondary outcome
overall survival rate
Time frame: 5years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2021.
- Individual participant dataSharing planned: No
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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.
Jihong Liu, PhD principal investigator
Sun Yat-sen University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Taxane and radical trachelectomy in people with Cervical Cancer, run by Sun Yat-sen University at 2 sites 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 1 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 7 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Yanling Feng, Doctor (+862013925090579, fengyl@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pregnancy rate (time frame: 5 years). 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 7 Jan 2021.