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

NCT02624531 | Unknown

• 1 other identifier: 2015-FXY-070
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Cervical Cancer

Keywords

NACT; Cervical cancer; Fertility sparing; Pregnancy; Treatment Strategy

Outcome Measures

Primary Outcomes (1)

• pregnancy rate

  5 years

Secondary Outcomes (1)

• overall survival rate

  5years

Study Arms (1)

fertility-sparing surgery

OTHER

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

Drug: Taxane; Procedure: radical trachelectomy

Interventions

Taxane DRUG

NACT and Fertility-sparing Treatment Strategy

Also known as: cisplatin

fertility-sparing surgery

radical trachelectomy PROCEDURE

NACT and Fertility-sparing Treatment Strategy

Also known as: simple trachelectomy, conization, sentinel node biopsy

fertility-sparing surgery

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• patients with cervical cancer staging IB1-IIA2 desiring keeping their fertility function

You may not qualify if:

• retroperitoneal lymph node metastasis, involvement of lower part of uterus and endometrial carcinoma

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (2)

Clinical Trial Center

Guangzhou, Guangdong, 510060, China

RECRUITING

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

taxane; Cisplatin; Conization; Sentinel Lymph Node Biopsy

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques; Lymph Node Excision

Study Officials

• Jihong Liu, PhD

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yanling Feng, Doctor

CONTACT

+862013925090579; fengyl@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pro.

Study Record Dates

• First Submitted: November 9, 2015
• First Posted: December 8, 2015
• Study Start: November 1, 2015
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: January 7, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)