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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000025552
Receipt No. 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 2019/07/12

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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
Email 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
Email sanae.sakamoto@ks-cc.or.jp

Sponsor
Institute Kyushu Study group of Clinical Cancer
Institute
Department

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
Email 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 No longer recruiting
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
2019 Year 07 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029357

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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