UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004351 |
|---|---|
| Receipt number | R000005187 |
| Scientific Title | A study on combinational effect of Krestin to the peripheral neuropathy by the FOLFOX treatment as adjuvant chemotherapy for Stage III colon cancer. |
| Date of disclosure of the study information | 2010/10/08 |
| Last modified on | 2012/10/19 10:01:38 |
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Basic information
Public title
A study on combinational effect of Krestin to the peripheral neuropathy by the FOLFOX treatment as adjuvant chemotherapy for Stage III colon cancer.
Acronym
A study on combinational effect of Krestin to the peripheral neuropathy by the FOLFOX treatment as adjuvant chemotherapy for Stage III colon cancer.
Scientific Title
A study on combinational effect of Krestin to the peripheral neuropathy by the FOLFOX treatment as adjuvant chemotherapy for Stage III colon cancer.
Scientific Title:Acronym
A study on combinational effect of Krestin to the peripheral neuropathy by the FOLFOX treatment as adjuvant chemotherapy for Stage III colon cancer.
Region
| Japan |
Condition
Condition
Colon cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In this randomized controlled study, patients with curatively resected Stage III colon cancer are assigned to postoperative adjuvant therapy with FOLFOX or FOLFOX plus Krestin to evaluate the efficacy of immunochemotherapy combined with Krestin. Endpoints are peripheral neuropathy or myelosuppresion such as neutropenia.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency of peripheral neuropathy
Key secondary outcomes
Frequency of neutropenia, other adverse events, medication adherence, QOL
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
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
FOLFOX
(1) FOLFOX4
Patients are registered and assigned within 6weeks after surgery. Levofolinate and Oxaliplatin (L-OHP) are given intravenously for 2 hours. Then, Fluorouracil (5-FU) is given as a continuous intravenous infusion for 22 hours after infusion (or injection) of 5-FU. And then, levofolinate is given intravenously for 2 hours, 5-FU is given as a continuous intravenous infusion for 22 hours after infusion (or injection) of 5-FU. 1 course takes 2 weeks. Treatment is repeated 12 courses (for 24 weeks).
(2) mFOLFOX6
Patients are registered and assigned within 6weeks after surgery. Levofolinate and L-OHP are given intravenously for 2 hours. Then, 5-FU is given as a continuous intravenous infusion for 46 hours after infusion (or injection) of 5-FU. 1 course takes 2 weeks. Treatment is repeated 12 courses (for 24 weeks).
Interventions/Control_2
FOLFOX/Krestin
Krestin is given orally at a fixed dose of 3g/day in three divided doses (morning, daytime, evening) for 24 weeks from the time of a FOLFOX treatment start.
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Histologically proven, Stage IIIa, IIIb, primary Colon adenocarcinoma (including RS) (Japanese Classification of Colorectal cancer 7th Ehition).
2. R0.
3. No preoperative cancer treatment, such as radiotherapy, chemotherapy and immunotherapy.
4. Age between 20 and 80 years.
5. ECOG performance status of 0-1.
6. Organ functions (clinical test value): within 2 weeks before enrollment.
White blood cell count: over 4000/mm3 and <12000/mm3
Neutrophil count (ANC): over 2000/mm3
Blood platelet count: over 100,000 /mm3
Hemoglobin: over 9.0g/dl
Serum total bilirubin: <1.5mg/dl
Serum AST and ALT: <100 IU/L
Serum creatinine: below 1.5mg/dL
Normal ECG
7. Patients who can take orally.
8. Written informed consent.
Key exclusion criteria
1. Patients who need continuing use of warfarin potassium and phenytoin.
2. A medical history of allergy (over grade 3) to any drug.
3. Patients with severe complication (such as ileus, interstitial lung disease, lung fibrosis, diabetes that is difficult to control, heart failure, renal failure, liver failure).
4. Women who are pregnant or hope to become pregnant.
5. No birth-control.
6. HIV positive.
7. Patients judged inappropriate for the study by their physicians.
Patients with intraepithelial carcinoma, adenoma cancer, synchronous or metachronous cancers are not exclusion criterion.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahiko Shibata |
Organization
Fukushima Medical University
Division name
Tumor Host Bioscience
Zip code
Address
1, Hikarigaoka, Fukushima city, 960-1295 Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Fukushima Medical University
Division name
Tumor Host Bioscience
Zip code
Address
1, Hikarigaoka, Fukushima city, 960-1295 Japan
TEL
Homepage URL
Sponsor or person
Institute
Tumor Host Bioscience, Fukushima Medical University
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
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 10 | Month | 08 | 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
| 2010 | Year | 08 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 10 | 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
| 2010 | Year | 10 | Month | 07 | Day |
Last modified on
| 2012 | Year | 10 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005187
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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