Neoadjuvant Chemotherapy + Surgery Versus Surgery in FIGO IB2 and IIA2 Cervical Cancer
SYSGO-003
A Trial of Neoadjuvant Chemotherapy Followed by Surgery Versus Surgery in FIGO IB2 and IIA2 Cervical Cancer(CSEM005)
1 other identifier
interventional
700
1 country
1
Brief Summary
To clarify the potential benefits of NACT before radical surgery(RS), we perform a phase III, randomised controlled trial to compare NACT plus RS with RS alone in patients with stages IB2 and IIA2 cervical cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2015
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2015
CompletedFirst Submitted
Initial submission to the registry
December 10, 2015
CompletedFirst Posted
Study publicly available on registry
December 14, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedMarch 16, 2018
March 1, 2018
7 years
December 10, 2015
March 14, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Disease free survival
2 years
Secondary Outcomes (2)
overall survival
5 years
quality of life
3 years
Study Arms (2)
A(NACT)
EXPERIMENTALNeoadjuvant Chemotherapy followed by Radical Surgery
B(RS)
ACTIVE COMPARATORRadical Surgery alone
Interventions
Paclitaxel 150mg/m2 over 3 hours + Cisplatin 70mg/m2 or carboplatin AUC = 6, repeat per 21 days, 3 cycles.
Radical hysterectomy (Piver Type III or Type IV hysterectomy) plus bilateral pelvic lymph node dissection and para-aortic lymph node dissection or sampling
Eligibility Criteria
You may qualify if:
- Patients with newly histologically confirmed cervical carcinoma;
- Histopathology squamaous carcinoma, adenocarcinoma or adeno-squamous carcinoma;
- Original clinical stage must be IB2 or IIA2 （FIGO);
- Age between 18-65;
- Patients must give signed informed consent;
- P.S status: 0-1;
- Estimated survival time \> 3 months;
You may not qualify if:
- The presence of uncontrolled life-threatening illness;
- Receiving other ways of anti-cancer therapy;
- Investigator consider the patients can't finish the whole study;
- With normal liver function test (ALT、AST\>2.5×ULN);
- With normal renal function test (Creatinine\>1.5×ULN);
- WBC\<4,000/mm3 or PLT\<100,000/mm;
- Accompany with other malignancy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sun Yat-sen University Cancer Center, Department of Gynecologic Oncology
Guangzhou, Guangdong, 510060, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jihong Liu, Ph.D
Sun Yat-sen University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof.
Study Record Dates
First Submitted
December 10, 2015
First Posted
December 14, 2015
Study Start
December 1, 2015
Primary Completion
December 1, 2022
Study Completion
December 1, 2022
Last Updated
March 16, 2018
Record last verified: 2018-03