UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005484 |
|---|---|
| Receipt number | 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 09:45:04 |
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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
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
hiroomio@gmail.com
Sponsor or person
Institute
Gunma University Graduate School of Medicine
Department of Thoracic and Visceral Organ Surgery
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006501
