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
CRIS Registration Number |
KCT0003214 |
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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
Board Approval Status | Submitted approval |
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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 Person for Principal Investigator / Scientific Queries | |
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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
Study Site | Multi-center Number of center : 14 - Multi-national} | |
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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
1. Source of Monetary/Material Support | |
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Organization Name | KGOG(Korea Gynecologic Oncology Group) |
Organization Type | Others |
Project ID | KGOG1027 |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Korea Cancer Center Hospital |
Organization Type | Medical Institute |
7. Study Summary
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). |
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8. Study Design
Study Type | Interventional Study |
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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
Condition(s)/Problem(s) |
* (C00-D48)Neoplasms (C53.9)Malignant neoplasm of cervix uteri, unspecified cervical cancer |
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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)
Type of Primary Outcome | /Safety/Efficacy | |
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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 |
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Timepoint | Overall Survival (OS) will be defined as observed length of life from entry into the study to death |
11. Study Results and Publication
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | No |
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