Neoadjuvant Chemotherapy and Radical Surgery in Stage IIB Cervical Cancer
SYSGO002
1 other identifier
interventional
220
1 country
1
Brief Summary
Neoadjuvant chemotherapy (NACT) and radical surgery (RS) may have a possible better outcome to concurrent chemoirradiation (CCRT) in stage IIB cervical cancer. We try to verify such a hypothesis in terms of survival and treatment related morbidity.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Nov 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
November 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 2, 2015
CompletedFirst Posted
Study publicly available on registry
November 3, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedFebruary 3, 2017
February 1, 2017
5.1 years
November 2, 2015
February 2, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Disease free survival
5 years
Secondary Outcomes (1)
Overall survival
5 years
Study Arms (2)
Concurrent chemoirradiation (CCRT)
ACTIVE COMPARATORConcurrent chemoirradiation
NACT+Surgery
EXPERIMENTALNeoadjuvant chemotherapy with Paclitaxel and Cisplatin (3 cycles), followed by radical surgery
Interventions
External beam radiation therapy (EBRT) with concurrent weekly platinum chemotherapy followed by brachytherapy
New adjuvant chemotherapy 3 cycles with Paclitaxel 150mg/m2 over 3 hours and Cisplatin
Radical hysterectomy (Type III or Type IV hysterectomy) plus bilateral pelvic lymph node dissection and para-aortic lymph node dissection or sampling
New adjuvant chemotherapy 3 cycles with Paclitaxel and Cisplatin 70mg/m2
Eligibility Criteria
You may qualify if:
- Patients with newly histologically confirmed cervical carcinoma
- Original clinical stage must be IIB （FIGO 2009）
- Histopathology squamous carcinoma, adenocarcinoma or adeno-squamous carcinoma
- Age between 18-65
- Patients must give signed informed consent
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/mm3
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Gynecologic Oncology, Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060, China
Related Publications (1)
Tu H, Huang H, Ouyang Y, Liu Q, Xian B, Song K, Chen G, Shen Y, Liu J. Neoadjuvant chemotherapy followed by radical surgery versus concurrent chemoradiotherapy in patients with FIGO stage IIB cervical cancer: the CSEM 006 study. Int J Gynecol Cancer. 2021 Jan;31(1):129-133. doi: 10.1136/ijgc-2020-001357. Epub 2020 Jun 9.
PMID: 32522771DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
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
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Sun Yat-sen University Cancer Center
Study Record Dates
First Submitted
November 2, 2015
First Posted
November 3, 2015
Study Start
November 1, 2015
Primary Completion
December 1, 2020
Study Completion
December 1, 2020
Last Updated
February 3, 2017
Record last verified: 2017-02