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Neoadjuvant Chemotherapy and Radical Surgery in Stage IIB Cervical Cancer (SYSGO002)

Primary Purpose

Cervical Carcinoma Stage IIB

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Concurrent chemoirradiation
Paclitaxel
Radical Surgery
Cisplatin
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Carcinoma Stage IIB focused on measuring Cervical cancer, Stage IIB, Neoadjuvant chemotherapy

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Department of Gynecologic Oncology, Sun Yat-sen University Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Concurrent chemoirradiation (CCRT)

NACT+Surgery

Arm Description

Concurrent chemoirradiation

Neoadjuvant chemotherapy with Paclitaxel and Cisplatin (3 cycles), followed by radical surgery

Outcomes

Primary Outcome Measures

Disease free survival

Secondary Outcome Measures

Overall survival

Full Information

First Posted
November 2, 2015
Last Updated
February 2, 2017
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT02595554
Brief Title
Neoadjuvant Chemotherapy and Radical Surgery in Stage IIB Cervical Cancer
Acronym
SYSGO002
Official Title
Neoadjuvant Chemotherapy and Radical Surgery Versus Concurrent Chemoirradiation in FIGO Stage IIB Cervical Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Unknown status
Study Start Date
November 2015 (undefined)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Patients with International Federation of Gynecology and Obstetrics (FIGO) stage IIB cervical cancer are eligible for our study. They will receive cisplatin based neoadjuvant chemotherapy (NACT) 3 cycles followed by radical surgery (RS) (type III to V radical hysterectomy plus systematic pelvic lymphadenectomy) (arm A) or external beam radiation (EBRT) with concurrent weekly platinum 40mg/m2 followed by brachyradiotherapy (arm B).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Carcinoma Stage IIB
Keywords
Cervical cancer, Stage IIB, Neoadjuvant chemotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Concurrent chemoirradiation (CCRT)
Arm Type
Active Comparator
Arm Description
Concurrent chemoirradiation
Arm Title
NACT+Surgery
Arm Type
Experimental
Arm Description
Neoadjuvant chemotherapy with Paclitaxel and Cisplatin (3 cycles), followed by radical surgery
Intervention Type
Radiation
Intervention Name(s)
Concurrent chemoirradiation
Intervention Description
External beam radiation therapy (EBRT) with concurrent weekly platinum chemotherapy followed by brachytherapy
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Other Intervention Name(s)
NACT
Intervention Description
New adjuvant chemotherapy 3 cycles with Paclitaxel 150mg/m2 over 3 hours and Cisplatin
Intervention Type
Procedure
Intervention Name(s)
Radical Surgery
Other Intervention Name(s)
NACT and surgery
Intervention Description
Radical hysterectomy (Type III or Type IV hysterectomy) plus bilateral pelvic lymph node dissection and para-aortic lymph node dissection or sampling
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Other Intervention Name(s)
NACT
Intervention Description
New adjuvant chemotherapy 3 cycles with Paclitaxel and Cisplatin 70mg/m2
Primary Outcome Measure Information:
Title
Disease free survival
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Overall survival
Time Frame
5 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jihong Liu, Ph. D
Phone
86-20-87343102
Email
Liujih@mail.sysu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
He Huang, Ph. D
Phone
86-20-87343014
Email
Huangh@sysucc.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jihong Liu, Ph. D
Organizational Affiliation
Sun Yat-sen University
Official's Role
Study Director
Facility Information:
Facility Name
Department of Gynecologic Oncology, 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
He Huang, Ph.D.
Phone
86-20-87343104
Email
huangh@sysucc.org.cn

12. IPD Sharing Statement

Citations:
PubMed Identifier
32522771
Citation
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.
Results Reference
derived

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Neoadjuvant Chemotherapy and Radical Surgery in Stage IIB Cervical Cancer

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