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Randomized Phase III Clinical Trial of Weekly versus Tri-weekly Cisplatin Based Chemoradiation in Locally Advanced Cervical Cancer

Status Approved

  • First Submitted Date

    2018/08/24

  • Registered Date

    2018/09/21

  • Last Updated Date

    2021/01/22

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0003214
    Unique Protocol ID GCIG/KGOG1027
    Public/Brief Title Randomized Phase III Clinical Trial of Weekly versus Tri-weekly Cisplatin Based Chemoradiation in Locally Advanced Cervical Cancer
    Scientific Title Randomized Phase III Clinical Trial of Weekly versus Tri-weekly Cisplatin Based Chemoradiation in Locally Advanced Cervical Cancer
    Acronym TACO
    MFDS Regulated Study Yes
    IND/IDE Protocol No
    Registered at Other Registry Yes
    Name of Registry / Registration Number
    Healthcare Benefit Approval Status Submitted approval
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number K-1112-001-003
    Approval Date 2011-12-07
    Institutional Review Board Name KIRAMS Institutional review board
    Institutional Review Board Address 75, Nowon-ro, Nowon-gu, Seoul
    Institutional Review Board Telephone 02-970-1389
    Data Monitoring Committee Yes
    Clinical trial steering committee
  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name sang young ryu
    Title investigator
    Telephone +82-2-970-2343
    Affiliation Korea Cancer Center Hospital
    Address 75, Nowon-ro, Nowon-gu, Seoul, Republic of Korea
    Contact Person for Public Queries
    Name SANG YOUNG RYU
    Title INVESTIGATOR
    Telephone +82-2-970-2343
    Affiliation Korea Cancer Center Hospital
    Address 75, Nowon-ro, Nowon-gu, Seoul, Republic of Korea
    Contact Person for Updating Information
    Name young sook choi
    Title CRA
    Telephone +82-2-512-5420
    Affiliation KGOG(Korea Gynecologic Oncology Group)
    Address 36, gangnam-daero 132 gil, gangnam-gu, seoul
  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Multi-center Number of center : 14 - Multi-national}
    Overall Recruitment Status Recruiting
    Date of First Enrollment 2012-04-26 Actual
    Target Number of Participant 374
    Primary Completion Date 2021-10-31 , Anticipated
    Study Completion Date 2023-03-31 , Anticipated
    Recruitment Status by Participating Study Site 1
    Name of Study Soon Chun Hyang University Hospital Cheonan
    Recruitment Status Active, not recruiting
    Date of First Enrollment 2012-08-01 ,
    Recruitment Status by Participating Study Site 2
    Name of Study Dongnam Institute of Radiological & Medical Sciences
    Recruitment Status Active, not recruiting
    Date of First Enrollment 2012-10-08 ,
    Recruitment Status by Participating Study Site 3
    Name of Study Gachon University Gil Medical Center
    Recruitment Status Completed
    Date of First Enrollment 2012-12-18 ,
    Recruitment Status by Participating Study Site 4
    Name of Study Yonsei University Health System, Gangnam Severance Hospital
    Recruitment Status Completed
    Date of First Enrollment 2013-04-02 ,
    Recruitment Status by Participating Study Site 5
    Name of Study Konkuk University Medical Center
    Recruitment Status Completed
    Date of First Enrollment 2013-04-23 ,
    Recruitment Status by Participating Study Site 6
    Name of Study Keimyung University Dongsan Hospital
    Recruitment Status Completed
    Date of First Enrollment 2012-10-25 ,
    Recruitment Status by Participating Study Site 7
    Name of Study Asan Medical Center
    Recruitment Status Active, not recruiting
    Date of First Enrollment 2014-03-13 ,
    Recruitment Status by Participating Study Site 8
    Name of Study Ewha Womans University Medical Center
    Recruitment Status Active, not recruiting
    Date of First Enrollment 2012-11-08 ,
    Recruitment Status by Participating Study Site 9
    Name of Study Yonsei University Health System, Severance Hospital
    Recruitment Status Completed
    Date of First Enrollment 2013-02-18 ,
    Recruitment Status by Participating Study Site 10
    Name of Study Hanyang University Seoul Hospital
    Recruitment Status Completed
    Date of First Enrollment 2013-03-06 ,
    Recruitment Status by Participating Study Site 11
    Name of Study Kosin University Gospel Hospital
    Recruitment Status Completed
    Date of First Enrollment 2012-10-26 ,
    Recruitment Status by Participating Study Site 12
    Name of Study The Catholic University of Korea, Seoul St. Mary's Hospital
    Recruitment Status Completed
    Date of First Enrollment 2013-05-15 ,
    Recruitment Status by Participating Study Site 13
    Name of Study Kyungpook National University Medical Center
    Recruitment Status Completed
    Date of First Enrollment 2013-05-14 ,
    Recruitment Status by Participating Study Site 14
    Name of Study Korea Cancer Center Hospital
    Recruitment Status Active, not recruiting
    Date of First Enrollment 2012-04-26 ,
  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name KGOG(Korea Gynecologic Oncology Group)
    Organization Type Others
    Project ID KGOG1027
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Korea Cancer Center Hospital
    Organization Type Medical Institute
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    Primary endpoint :To determine if the tri-weekly cisplatin chemotherapy during radiation improves overall survival compared to standard weekly cisplatin.
    Secondary endpoints : To determine: progression-free survival, recurrence rate, pattern of disease recurrence,  acute and long term adverse events, compliance to radiation protocol and quality of life
    
    Study design : Prospective, multi-center, randomized, phase III 
    Patient population : Patients with 1B2, 2B, 3B or 4A cervical cancer suitable for primary treatment with chemoradiation with curative intent
    Intervention : Cisplatin will be given during the radiation at a dose of 40mg/m2 weekly six cycles (Arm A) or 75mg/m2 tri-weekly three cycles (Arm B).
  • 8. Study Design

    Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
    Study Type Interventional Study
    Study Purpose
    Treatment
    Phase Phase3
    Intervention Model Parallel  
    Blinding/Masking Open
    Allocation RCT
    Intervention Type Drug, Radiation  
    Intervention Description
    Arm A (Control arm)
    Weekly cisplatin 40mg/m2 six cycles concurrent to radiation therapy
    Arm B (Experimental arm)
    Tri-weekly cisplatin 75mg/m2 three cycles concurrent to radiation therapy
    Number of Arms 2
    Arm 1

    Arm Label

    Tri-weekly cisplatin concurrent to radiation therapy

    Target Number of Participant

    100

    Arm Type

    Experimental

    Arm Description

    Tri-weekly cisplatin 75mg/m2 three cycles concurrent to radiation therapy
    Arm 2

    Arm Label

    Weekly cisplatin concurrent to radiation therapy

    Target Number of Participant

    100

    Arm Type

    Active comparator

    Arm Description

    Weekly cisplatin 40mg/m2 six cycles concurrent to radiation therapy
  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s) * (C00-D48)Neoplasms 
       (C53.9)Malignant neoplasm of cervix uteri, unspecified 

    cervical cancer
    Rare Disease No
    Inclusion Criteria

    Gender

    Female

    Age

    18Year~No Limit

    Description

    3.1.1. Eligible patients will have pathologically proven primary locally advanced cervical cancer with squamous cell carcinoma, adenosquamous carcinoma or adenocarcinoma histology suitable for primary treatment with chemoradiation with curative intent
    3.1.2. FIGO stage 1B2, 2B, 3B, 4A
    3.1.3. Age 18 years or older 
    3.1.4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
    3.1.5. Patients must have adequate:
    -Hematologic function: ANC ≥ 1,500/mcl and platelets ≥ 100,000/mcl
    -Renal function: serum creatinine ≤ ULN or calculated creatinine clearance ≥ 60 mL/min
    -Hepatic function: serum bilirubin ≤ 1.5 x ULN and AST ≤ 2.5 x ULN and ALT≤ 2.5 x ULN
    3.1.6. Patients must have signed an approved informed consent
    Exclusion Criteria
    3.2.1. Patients with cervix cancer who have received any previous radiation or chemotherapy
    3.2.2. Patients assessed at presentation as requiring interstitial brachytherapy treatment
    3.2.3. FIGO stage 3A disease
    3.2.4. Para-aortic nodal involvement above the level of the common iliac nodes or L3/L4 (if biopsy proven, PET positive or > 15mm short axis diameter on CT)
    3.2.5. Patients with bilateral hydronephrosis unless at least one side has been stented and renal function fulfils the required inclusion criteria
    3.2.6. Previous chemotherapy for this tumor
    3.2.7. Evidence of distant metastases
    3.2.8. Prior diagnosis of Crohn’s disease or ulcerative colitis
    3.2.9. Patients who are pregnant or lactating
    3.2.10. History of other invasive malignancies, with the exception of non-melanoma skin cancer and in situ melanoma, who had (or have) any evidence of the other cancer present within the last 5 years
    3.2.11. Serious illness or medical condition that precludes the safe administration of the trial treatment including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
    Healthy Volunteers No
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome /Safety/Efficacy
    Primary Outcome(s) 1
    Outcome
    To determine if the tri-weekly cisplatin chemotherapy during radiation improves 3-year progression free survival compared to standard weekly cisplatin
    Timepoint
    From the time of randomization to when the investigator diagnosed disease progression or death from any cause
    Secondary Outcome(s) 1
    Outcome
    pattern of disease recurrence
    Timepoint
    From the time of randomization to when the investigator diagnosed disease progression or death from any cause
    Secondary Outcome(s) 2
    Outcome
    acute and long term adverse events
    Timepoint
    From the time of randomization to the end of the study
    Secondary Outcome(s) 3
    Outcome
    compliance to radiation protocol
    Timepoint
    From the time of randomization to when the investigator diagnosed disease progression or death from any cause
    Secondary Outcome(s) 4
    Outcome
    Quality of life
    Timepoint
    Before the randomization and 3weeks, 7weeks and 9months from the first cycle of CCRT
    Secondary Outcome(s) 5
    Outcome
    The recurrence rate and pattern of disease recurrence
    Timepoint
    It is defined as a clinical, radiologic, or histologic recurrence of disease after initiation of clinical trials
    Secondary Outcome(s) 6
    Outcome
    5-year overall survival
    Timepoint
    Overall Survival (OS) will be defined as observed length of life from entry into the study to death
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered No
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement No
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