Prospective Study of Fertility-sparing Treatment Strategy in Patients With Early Cervical Cancer(SYSUGO-005/CSEM009) (SYSUGO-005)
Primary Purpose
Cervical Cancer
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Taxane
radical trachelectomy
Sponsored by
About this trial
This is an interventional treatment trial for Cervical Cancer focused on measuring NACT, Cervical cancer, Fertility sparing, Pregnancy, Treatment Strategy
Eligibility Criteria
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
Sites / Locations
- Clinical Trial CenterRecruiting
- Sun Yat-sen University Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
fertility-sparing surgery
Arm Description
NACT with Taxane combined with cisplatin and Fertility-sparing Treatment Strategy
Outcomes
Primary Outcome Measures
pregnancy rate
Secondary Outcome Measures
overall survival rate
Full Information
NCT ID
NCT02624531
First Posted
November 9, 2015
Last Updated
January 6, 2021
Sponsor
Sun Yat-sen University
1. Study Identification
Unique Protocol Identification Number
NCT02624531
Brief Title
Prospective Study of Fertility-sparing Treatment Strategy in Patients With Early Cervical Cancer(SYSUGO-005/CSEM009)
Acronym
SYSUGO-005
Official Title
Prospective Study of Fertility-sparing Treatment Strategy in Patients With Early Cervical Cancer(SYSUGO-005/CSEM009)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Recruiting
Study Start Date
November 2015 (undefined)
Primary Completion Date
November 2025 (Anticipated)
Study Completion Date
November 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer
Keywords
NACT, Cervical cancer, Fertility sparing, Pregnancy, Treatment Strategy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
fertility-sparing surgery
Arm Type
Other
Arm Description
NACT with Taxane combined with cisplatin and Fertility-sparing Treatment Strategy
Intervention Type
Drug
Intervention Name(s)
Taxane
Other Intervention Name(s)
cisplatin
Intervention Description
NACT and Fertility-sparing Treatment Strategy
Intervention Type
Procedure
Intervention Name(s)
radical trachelectomy
Other Intervention Name(s)
simple trachelectomy, conization, sentinel node biopsy
Intervention Description
NACT and Fertility-sparing Treatment Strategy
Primary Outcome Measure Information:
Title
pregnancy rate
Time Frame
5 years
Secondary Outcome Measure Information:
Title
overall survival rate
Time Frame
5years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yanling Feng, Doctor
Phone
+862013925090579
Email
fengyl@sysucc.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jihong Liu, PhD
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Trial Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jihong Liu, Ph.D.
Phone
86-20-87343102
Email
Liujih@mail.sysu.edu.cn
First Name & Middle Initial & Last Name & Degree
Yanling Feng, Ph.D.
Phone
86-20-87343104
Email
fengyl@sysucc.org.cn
Facility Name
Sun Yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jihong Liu, Ph.D.
Phone
86-20-87343102
Email
Liujih@mail.sysu.edu.cn
First Name & Middle Initial & Last Name & Degree
Yanling Feng, Ph.D.
Phone
86-20-87343104
Email
fengyl@sysucc.org.cn
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Prospective Study of Fertility-sparing Treatment Strategy in Patients With Early Cervical Cancer(SYSUGO-005/CSEM009)
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