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Prospective Study of Fertility-sparing Treatment Strategy in Patients With Early Cervical Cancer(SYSUGO-005/CSEM009)

Sponsor
Sun Yat-sen University (Other)
Overall Status
Recruiting
CT.gov ID
NCT02624531
Collaborator
(none)
60
Enrollment
2
Locations
1
Arm
120
Duration (Months)
30
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Prospective Study of Fertility-sparing Treatment Strategy in Patients With Early Cervical Cancer(SYSUGO-005/CSEM009)
Study Start Date :
Nov 1, 2015
Anticipated Primary Completion Date :
Nov 1, 2025
Anticipated Study Completion Date :
Nov 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Other: fertility-sparing surgery

NACT with Taxane combined with cisplatin and Fertility-sparing Treatment Strategy

Drug: Taxane
NACT and Fertility-sparing Treatment Strategy
Other Names:
  • cisplatin

    • Procedure: radical trachelectomy
    NACT and Fertility-sparing Treatment Strategy
    Other Names:
  • simple trachelectomy
  • conization
  • sentinel node biopsy

    		•

    Outcome Measures

    Primary Outcome Measures

    1. pregnancy rate [5 years]

    Secondary Outcome Measures

    1. overall survival rate [5years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 40 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Clinical Trial Center Guangzhou Guangdong China 510060
    2 Sun Yat-sen University Cancer Center Guangzhou Guangdong China 510060

    Sponsors and Collaborators

    • Sun Yat-sen University

    Investigators

    • Principal Investigator: Jihong Liu, PhD, Sun Yat-sen University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jihong Liu, Pro., Sun Yat-sen University
    ClinicalTrials.gov Identifier:
    NCT02624531
    Other Study ID Numbers:
    • 2015-FXY-070
    First Posted:
    Dec 8, 2015
    Last Update Posted:
    Jan 7, 2021
    Last Verified:
    Jan 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Jihong Liu, Pro., Sun Yat-sen University
    NACT
    Cervical cancer
    Fertility sparing
    Pregnancy
    Treatment Strategy
    Additional relevant MeSH terms:
    Uterine Cervical Neoplasms
    Cisplatin
    Taxane

    Study Results

    No Results Posted as of Jan 7, 2021