Prospective Study of Fertility-sparing Treatment Strategy in Patients With Early Cervical Cancer(SYSUGO-005/CSEM009)
NCT ID: NCT02624531
Last Updated: 2021-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2015-11-30
2025-11-30
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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fertility-sparing surgery
NACT with Taxane combined with cisplatin and Fertility-sparing Treatment Strategy
Taxane
NACT and Fertility-sparing Treatment Strategy
radical trachelectomy
NACT and Fertility-sparing Treatment Strategy
Interventions
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Taxane
NACT and Fertility-sparing Treatment Strategy
radical trachelectomy
NACT and Fertility-sparing Treatment Strategy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
40 Years
FEMALE
No
Sponsors
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Sun Yat-sen University
OTHER
Responsible Party
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Jihong Liu
Pro.
Principal Investigators
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Jihong Liu, PhD
Role: PRINCIPAL_INVESTIGATOR
Sun Yat-sen University
Locations
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Clinical Trial Center
Guangzhou, Guangdong, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2015-FXY-070
Identifier Type: -
Identifier Source: org_study_id
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