UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005484
Receipt No. R000006501
Scientific Title A Randomized Trial of Adjuvant Chemotherapy with UFT / LV versus PSK / UFT / LV following curative resection for Stage II / III Colorectal Cancer
Date of disclosure of the study information 2011/04/22
Last modified on 2018/10/28

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title A Randomized Trial of Adjuvant Chemotherapy with UFT / LV versus PSK / UFT / LV following curative resection for Stage II / III Colorectal Cancer
Acronym Trial of Adjuvant Chemotherapy with PSK / UFT / LV
Scientific Title A Randomized Trial of Adjuvant Chemotherapy with UFT / LV versus PSK / UFT / LV following curative resection for Stage II / III Colorectal Cancer
Scientific Title:Acronym Trial of Adjuvant Chemotherapy with PSK / UFT / LV
Region
Japan

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

Objectives
Narrative objectives1 To investigate efficacy and safety of PSK/UFT/LV 6M and 12M as compared to UFT/LV 6M for an adjuvant therapy in patients with stage II/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 3 year desease free survival rate
Key secondary outcomes Survival time
Adverse event rate
Completion rate

Base
Study type Interventional

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

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Group A (standard therapy group:UFT/LV 6M): Administration of 5 courses (6 months) of a schedule in which one course consists of UFT (300 mg/m2/day) and LV (75 mg/day) for 28 consecutive days followed by 7 days off the drugs.
Interventions/Control_2 Group B (trial therapy group: PSK/UFT/LV 6M): Administration of 5 courses (6 months) of a schedule in which one course consists of UFT (300 mg/m2/day) and LV (75 mg/day) for 28 consecutive days followed by 7 days off the drugs.
And administration of every day PSK (3g/body) for 6 months.
Interventions/Control_3 Group C (trial therapy group: PSK/UFT/LV 12M): Administration of 10 courses (12 months) of a schedule in which one course consists of UFT (300 mg/m2/day) and LV (75 mg/day) for 28 consecutive days followed by 7 days off the drugs.
And administration of every day PSK (3g/body) for 12 months.
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
80 years-old >=
Gender Male and Female
Key inclusion criteria 1.Histologically proven colorectal cancer.
2.StageII high risk/III colon cancer(C, A, T, D, S), rectal cancer(RS, Ra).
3.Curability A
4.Age between 20 and 80 years.
5.No prior chemotherapy or radiation.
6.Patients who could measure preoperative lymphocyte ratio.
7.Performance status of 0-1.
8.Patients who have satisfied the following the clinical test values within two weeks before the registration.
1)WBC:>= 3,000/mm3, <12,000/mm3
2)Neutrophile:>= 1,500/mm3
3)Hemoglobin:>= 9.0g/dL
4)Platelet:>= 100,000/mm3
5)AST(GOT),ALT(GPT): = <100IU/L
6)Total bilirubin: = < 2.0 mg/dL
7)Serum creatinine: =<1.5mg/dL
9.Patient with starting the treatment within 8 weeks after operation.
10.Written informed consent.
Key exclusion criteria 1.Synchronous or metachronous colorectal cancer.
2.Severe infectious disease.
3.Severe postoperative complications.
4.Patients with following complications.
1)Uncontrolled diabetes or hyperpiesia.
2)Myocardial infarction within the past 6 months or unstable angina pectoris.
3)Hepatic cirrhosis , interstitial pneumonia , lung fibrosis, advanced pneumonectasia
5.Patients with diarrhea more than 3 times/day.
6.Active synchronous or metachronous malignancy carcinoma in situ.
7.Female who are pregnant, nursing, suspected of being pregnant or hope to become pregnant during the study period
8.Not suitable for participating in the study for any other reason.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Izumi TAKEYOSHI
Organization Gunma University Graduate School of Medicine
Division name Department of Thoracic and Visceral Organ Surgery
Zip code
Address 3-39-22 Showa-Machi, Maebashi, Gunma, 371-8511, JAPAN
TEL 027-220-8245
Email takeyoshi@gunma-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroomi OGAWA
Organization Gunma University Graduate School of Medicine
Division name Department of Thoracic and Visceral Organ Surgery
Zip code
Address 3-39-22 Showa-machi, Maebashi, Gunma 371-8511, JAPAN
TEL 027-220-8245
Homepage URL
Email hiroomio@gmail.com

Sponsor
Institute Gunma University Graduate School of Medicine
Department of Thoracic and Visceral Organ Surgery
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 群馬大学医学部附属病院(群馬県)他

Other administrative information
Date of disclosure of the study information
2011 Year 04 Month 22 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 Completed
Date of protocol fixation
2011 Year 03 Month 09 Day
Date of IRB
Anticipated trial start date
2011 Year 04 Month 01 Day
Last follow-up date
2018 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 04 Month 22 Day
Last modified on
2018 Year 10 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006501

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.