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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000010980
Receipt No. R000012856
Scientific Title Randomized phase II study with UFT capsule /LV or UFT E-granule /LV adjuvant chemotherapy for patients with completely resected high-risk stage II and III colorectal cancer
Date of disclosure of the study information 2013/06/18
Last modified on 2013/06/17

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Basic information
Public title Randomized phase II study with UFT capsule /LV or UFT E-granule /LV adjuvant chemotherapy for patients with completely resected high-risk stage II and III colorectal cancer
Acronym HORE CC01
Scientific Title Randomized phase II study with UFT capsule /LV or UFT E-granule /LV adjuvant chemotherapy for patients with completely resected high-risk stage II and III colorectal cancer
Scientific Title:Acronym HORE CC01
Region
Japan

Condition
Condition colorecrtal cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To demonstrate the clinical effectiveness of the UFT/LV for the patients with Stage II with risk factors of recurrence and III colorectal cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes treatment complete rate
Key secondary outcomes Safety, Dose Intensity, QOL(EORTC QLQ-C30), Relapse free survival,overall survival

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 UFT capsule / LV for 28 days with 7 days rest for 180days (6months)(1 course=5weeks, 35days).
Interventions/Control_2 UFT E-granule / LV for 28 days with 7 days rest for 180days (6months)(1 course=5weeks, 35days).
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) Histologically confirmed Colorectal cancer
2)high-risk Stage II-III
3) Performance Status (ECOG) 0-1
4) more than 20 years old
5) hasn't received any treatment other than R0 resection.
6) can start the therapy within 8 weeks after surgery.
7) Adequate organ functions
8) Oral intake is possible
9) Written informed consent
Key exclusion criteria A patient:
1)with administration contraindications for UFT,LV.
2)with active synchronous or metachronous malignancy other than carcinoma in situ(within 5 years).
3)has severe postoperative complications such as serious postoperative infectious disease,anastomotic leak and gastrointestinal bleeding.
4) has severe diarrhea.
5)has severe drug hypersensitivity.
6)is a pregnant woman or a woman suspected of being pregnant,or,is a man who hopes to make his partner pregnant.
7)with psychosis or psychoneurosis.
8)In case that the doctor judged that he/she is disqualified for the enrollment in this clinical trial.
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Konno
Organization Hamamatsu University School of Medicine
Division name Second Department of Surgery
Zip code
Address 1-20-1, Handayama Hamamatsu Shizuoka 431-3192, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kiyotaka Kurachi
Organization Hamamatsu University School of Medicine
Division name Second Department of Surgery
Zip code
Address 1-20-1, Handayama Hamamatsu Shizuoka 431-3192, Japan
TEL 053-435-2279
Homepage URL
Email

Sponsor
Institute HORE
Institute
Department

Funding Source
Organization None
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
Address
Tel
Email

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 磐田市立総合病院
浜松医療センター
静岡市立清水病院
松愛会 松田病院

Other administrative information
Date of disclosure of the study information
2013 Year 06 Month 18 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
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 Open public recruiting
Date of protocol fixation
2013 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 05 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 06 Month 17 Day
Last modified on
2013 Year 06 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012856

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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