UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025552 |
|---|---|
| Receipt number | R000029357 |
| Scientific Title | The clininal significance of identification technique of trifluridine incorporated into DNA in colorectal cancer patients treated with trifluridine / tipiracil.( KSCC 1602-A) |
| Date of disclosure of the study information | 2017/01/05 |
| Last modified on | 2021/01/07 11:03:31 |
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Basic information
Public title
The clininal significance of identification technique of trifluridine incorporated into DNA in colorectal cancer patients treated with trifluridine / tipiracil.( KSCC 1602-A)
Acronym
The clininal significance of identification technique of trifluridine incorporated into DNA in colorectal cancer patients treated with trifluridine / tipiracil.( KSCC 1602-A)
Scientific Title
The clininal significance of identification technique of trifluridine incorporated into DNA in colorectal cancer patients treated with trifluridine / tipiracil.( KSCC 1602-A)
Scientific Title:Acronym
The clininal significance of identification technique of trifluridine incorporated into DNA in colorectal cancer patients treated with trifluridine / tipiracil.( KSCC 1602-A)
Region
| Japan |
Condition
Condition
Colorectal Cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We examined the proportion of FTD incorporated into DNA in metastatic colorectal cancer patients treated with TFTD. We also analyzed the association between the proportion of FTD positive cells and various clinical factors, such as the response rate or the frequency of the adverse effect of TFTD in the patients enrolled KSCC1602.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The association between the proportion of FTD positive cells and the response rate, overall survival or the frequency of the adverse effect of TFTD.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The patients were additionally taken 7.5ml blood samples on the day1, 8, 15 and 29 of the protocol regimen.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients providing the written informed consent.
2) Patients are >=70 years of age (age at the time of enrollment)
3) Patients with colorectal cancer (excluding appendiceal cancer) pathologically diagnosed.
4) Unresectable colorectal cancer and chemotherapy was not performed as pre-treatment (recurrent patients under adjuvant therapy and within 6 months after adjuvant therapy excluding adjuvant therapy for pathological stage II - III are ineligible)
5) Patients with any of the following:
(1) Patients who the standard therapy is possible, but does not enforce the standard therapy by the consultation of investigator and patient (fit)
(2) Patients who cannot be received the same standard treatment as a general young people, but can be received some kind of treatment (vulnerable).
6) Performance Status (ECOG) 0 or 1
7) Patients capable of treatment with oral medicine
8) Patients have measurable lesion according to RECIST version 1.1 criteria by trunk part contract-enhanced CT within 28 days before enrollment
9) Patients with sufficient organ function
10) He/she can accept contraception by an appropriate method from the study drug administration to 6 months after final administration.
11) The patient has no severe dysfunction of major organs (bone marrow, liver, kidneys, heart, lungs, etc.) and the patient's laboratory results from up to 14 days prior to enrollment fall within the criteria
i) WBC <=12,000/mm3
ii) Neutrophil >=1,500/mm3
iii) Platelet >=100,000/mm3
iv) Hemoglobin >=8.0g/dL
v) Total bilirubin <=1.5mg/dL
vi) AST, ALT <=100IU/L
vii) Albumin >=2.5g/dL
viii) Serum creatinine <=1.5mg/dL
ix) Creatinine clearance >=60mL/min
Key exclusion criteria
1) Serious drug-induced hypersensitivity (especially, platinum formulation, 5-FU, TFTD)
2) Patients received palliative operation (it is eligible at 28 days after the operation with the intestinal anastomosis, at 14 days after colostomy)
3) Patients with active infectious disorder
4) Patients with uncontrollable hypertension.
5) Patients with under treatment by continuous use of insulin or with complication of uncontrollable diabetes mellitus
6) Patients with cardiac disorder such as congestive heart failure, angina to need medication, transmural myocardial infarction definitely observed in ECG, clinically apparent valvular disease, symptomatic coronary disease, uncontrollable arrhythmia, anamnesis of myocardial infarction that developed within the past 12 months.
7) Patients with severe pulmonary disorder such as interstitial pneumonia, pulmonary fibrosis, severe emphysema.
8) Patients with mental disorder or with anamnesis of central nervous system disorder.
9) Patients who have the fresh bleeding from gastrointestinal tract needing a transfusion repeatedly.
10) Patients who are receiving anticoagulant.
11) Patients with watery stool (>=Grade2)
12) Active double cancer.
Synchronous double cancer and metachronous double cancer within a disease-free interval of 5 years. Lesions consistent with carcinoma in situ or intramucosal carcinoma that have been cured by local treatment are not classified as active multiple cancers.
13) Male patients with hope of pregnancy of his partner.
14) Patients with cirrhosis or active hepatitis.
15) Any other patients who are regarded as unsuitable for this study by the investigators
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Eiji |
| Middle name | |
| Last name | Oki |
Organization
Graduate School of Medical Sciences, Kyushu University
Division name
Department of Surgery and Science, Graduate School of Medical Sciences
Zip code
812-8582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka, Japan
TEL
092-409-3500
sanae.sakamoto@ks-cc.or.jp
Public contact
Name of contact person
| 1st name | KSCC |
| Middle name | |
| Last name | Research Secretariat |
Organization
Kyushu Study group of Clinical Cancer
Division name
KSCC Research Secretariat
Zip code
812-8582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka, Japan
TEL
092-409-3500
Homepage URL
sanae.sakamoto@ks-cc.or.jp
Sponsor or person
Institute
Kyushu Study group of Clinical Cancer
Institute
Department
Personal name
Funding Source
Organization
Graduate School of Medical Sciences, Kyushu University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyushu University Ethics Review Board
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka, Japan
Tel
092-641-1151
byssien@jimu.kyushu-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
光晴会病院（長崎県）
JCHO人吉医療センター（熊本県）
薫風会佐野病院(兵庫県）
九州大学（福岡県）
国立病院機構九州医療センター（福岡県）
済生会福岡総合病院（福岡県）
製鉄記念八幡病院（福岡県）
社会保険田川病院（福岡県）
久留米大学（福岡県）
JCHO久留米総合病院（福岡県）
公立八女総合病院（福岡県）
長崎大学（長崎県）
国立病院機構長崎医療センター（長崎県）
大分県立病院（大分県）
国立病院機構大分医療センター（大分県）
中津市立中津市民病院（大分県）
今給黎総合病院（鹿児島県）
鹿児島厚生連病院（鹿児島県）
鹿児島県立薩南病院（鹿児島県）
松山赤十字病院（愛媛県）
熊本地域医療センター（熊本県）
宗像医師会病院（福岡県）
福岡大学（福岡県）
神戸市立医療センター中央市民病院（兵庫県）
田川市立病院（福岡県）
神戸大学（兵庫県）
九州大学病院別府病院（大分県）
JCHO九州病院（福岡県）
佐賀大学（佐賀県）
香川大学（香川県）
柿添病院（長崎県）
飯塚病院（福岡県）
国立病院機構佐賀病院（佐賀県）
熊本大学（熊本県）
広島赤十字・原爆病院（広島県）
伊万里有田共立病院（佐賀県）
中頭病院（沖縄県）
国立病院機構福岡東医療センター（福岡県）
琉球大学（沖縄県）
鹿児島大学（鹿児島県）
豊見城中央病院（沖縄県）
大分中村病院（大分県）
国立病院機構別府医療センター（大分県）
慈愛会今村総合病院（鹿児島県）
公立学校共済組合九州中央病院（福岡県）
ハートライフ病院（沖縄県）
済生会川内病院（鹿児島県）
大分赤十字病院（大分県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 01 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
39
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 11 | Month | 22 | Day |
Date of IRB
| 2017 | Year | 02 | Month | 14 | Day |
Anticipated trial start date
| 2016 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 01 | Month | 05 | Day |
Last modified on
| 2021 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029357
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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