- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02624531
Prospective Study of Fertility-sparing Treatment Strategy in Patients With Early Cervical Cancer(SYSUGO-005/CSEM009) (SYSUGO-005)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Yanling Feng, Doctor
- Phone Number: +862013925090579
- Email: fengyl@sysucc.org.cn
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510060
- Recruiting
- Sun Yat-Sen University Cancer Center
-
Contact:
- Jihong Liu, Ph.D.
- Phone Number: 86-20-87343102
- Email: Liujih@mail.sysu.edu.cn
-
Contact:
- Yanling Feng, Ph.D.
- Phone Number: 86-20-87343104
- Email: fengyl@sysucc.org.cn
-
Guangzhou, Guangdong, China, 510060
- Recruiting
- Clinical Trial Center
-
Contact:
- Jihong Liu, Ph.D.
- Phone Number: 86-20-87343102
- Email: Liujih@mail.sysu.edu.cn
-
Contact:
- Yanling Feng, Ph.D.
- Phone Number: 86-20-87343104
- Email: fengyl@sysucc.org.cn
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- patients with cervical cancer staging IB1-IIA2 desiring keeping their fertility function
Exclusion Criteria:
- retroperitoneal lymph node metastasis, involvement of lower part of uterus and endometrial carcinoma
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: fertility-sparing surgery
NACT with Taxane combined with cisplatin and Fertility-sparing Treatment Strategy
|
NACT and Fertility-sparing Treatment Strategy
Other Names:
NACT and Fertility-sparing Treatment Strategy
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
pregnancy rate
Time Frame: 5 years
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
overall survival rate
Time Frame: 5years
|
5years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jihong Liu, PhD, Sun Yat-sen University
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015-FXY-070
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cervical Cancer
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University of California, San DiegoWithdrawnCervical Cancer | Cervical Cancer Stage | Cervical Cancer Stage IB2 | Cervical Cancer Stage IB1 | Cervical Cancer Stage I | Cervical Cancer Stage IB | Cervical Cancer Stage II | Cervical Cancer Stage IIa | Cervical Cancer, Stage IIB | Cervical Cancer, Stage III | Cervical Cancer Stage IIIB | Cervical Cancer... and other conditionsUnited States
-
M.D. Anderson Cancer CenterWithdrawnStage IB3 Cervical Cancer FIGO 2018 | Stage II Cervical Cancer FIGO 2018 | Stage IIA Cervical Cancer FIGO 2018 | Stage IIA1 Cervical Cancer FIGO 2018 | Stage IIA2 Cervical Cancer FIGO 2018 | Stage IIB Cervical Cancer FIGO 2018 | Stage III Cervical Cancer FIGO 2018 | Stage IIIA Cervical Cancer FIGO... and other conditions
-
Abramson Cancer Center of the University of PennsylvaniaWithdrawnCervical Cancer | Stage IB Cervical Cancer | Stage IIA Cervical Cancer | Stage IIB Cervical Cancer | Stage III Cervical Cancer | Stage IVA Cervical Cancer
-
National Cancer Institute (NCI)CompletedCervical Adenocarcinoma | Cervical Squamous Cell Carcinoma | Stage IB Cervical Cancer | Stage IIA Cervical Cancer | Stage IIB Cervical Cancer | Stage III Cervical Cancer | Stage IVA Cervical Cancer | Stage IVB Cervical CancerUnited States
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Mayo ClinicNational Cancer Institute (NCI)RecruitingCervical Adenosquamous Carcinoma | Cervical Squamous Cell Carcinoma, Not Otherwise Specified | Recurrent Cervical Carcinoma | Stage IB3 Cervical Cancer FIGO 2018 | Stage II Cervical Cancer FIGO 2018 | Stage IIA Cervical Cancer FIGO 2018 | Stage IIA1 Cervical Cancer FIGO 2018 | Stage IIA2 Cervical... and other conditionsUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingStage IA Cervical Cancer | Stage IB Cervical Cancer | Stage IA1 Cervical Cancer | Stage IA2 Cervical Cancer | Stage IB1 Cervical Cancer | Stage IB2 Cervical Cancer | Stage IB3 Cervical CancerUnited States
-
Shanghai First Maternity and Infant HospitalNot yet recruitingCervical Cancer, Stage IIB | Cervical Cancer Stage IIIB | Cervical Cancer Stage IIIA | Cervical Cancer, Stage IVA
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Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedCervical Adenocarcinoma | Cervical Squamous Cell Carcinoma | Stage IB Cervical Cancer | Stage IIA Cervical Cancer | Stage IIB Cervical Cancer | Stage III Cervical Cancer | Stage IVA Cervical CancerUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)CompletedRecurrent Cervical Cancer | Stage IVA Cervical Cancer | Stage IVB Cervical Cancer | Stage IIIA Cervical Cancer | Stage IIIB Cervical CancerUnited States
-
Institut de Cancérologie de LorraineCompletedCervical Adenocarcinoma | Stage IB Cervical Cancer | Stage III Cervical Cancer | Stage II Cervical CancerFrance
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