UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006541 |
|---|---|
| Receipt number | R000007751 |
| Scientific Title | A randomized trial of postoperative adjuvant chemotherapy with capecitabine versus capecitabine/PSK following curative resection for stage III colon cancer. |
| Date of disclosure of the study information | 2011/10/14 |
| Last modified on | 2011/10/14 11:27:32 |
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Basic information
Public title
A randomized trial of postoperative adjuvant chemotherapy with capecitabine versus capecitabine/PSK following curative resection for stage III colon cancer.
Acronym
A randomized trial of postoperative adjuvant chemotherapy with capecitabine versus capecitabine/PSK following curative resection for stage III colon cancer.
Scientific Title
A randomized trial of postoperative adjuvant chemotherapy with capecitabine versus capecitabine/PSK following curative resection for stage III colon cancer.
Scientific Title:Acronym
A randomized trial of postoperative adjuvant chemotherapy with capecitabine versus capecitabine/PSK following curative resection 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
To evaluate availability of postoperative immunochemotherapy using PSK, conduct a randomized controlled trial of postoperative adjuvant therapy with capecitabine versus capecitabine/PSK following curative resection for histological stage III colon cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Adverse events rate
Key secondary outcomes
3 years disease free survival, 3 years relapse free survival, 3 years overall survival, compliance, QOL
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Capecitabine treatment group
Group A (capecitabine group)
Protocol treatment starts within 6 weeks after surgery. Capecitabine is administrated dosage corresponding body surface area twice a day (within 30 minutes after breakfast and dinner) orally for 14 days followed by 7-days resting period without treatment (one cycle) for 8 cycles.
Interventions/Control_2
Capecitabine/PSK treatment group
Group B (capecitabine/PSK group)
Protocol treatment starts within 6 weeks after surgery. Capecitabine is administrated as group A. PSK is administrated orally each day (3g/day, three times a day) for 24 weeks. PSK is administrated with capecitabine in the mornings and evenings, and after lunch in the day.
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 cancer (not including RS) (Japanese Classification of Colorectal cancer 7th Ehition).
2.R0, R1.
3.No prior cancer treatment (radiationtherapy, chemotherapy, immunotherapy) before surgery.
4.Age between 20 and 80 years.
5.Performance status of 0-1.
6.Restriction about combined medicine, combination therapy: Chemotherapeutic agent, immunotherapeutic agent or radiation therapy that may effect on this study's result is not combined in principle, except for metastasis or relapse.
7.Organ functions (clinical test value): within 2 weeks before enrollment.
White blood cell count: >= 4,000/mm3 and <12,000/mm3
Neutrophil count (ANC): >= 2,000/mm3
Blood platelet count: >= 90,000 /mm3
Hemoglobin: >= 9.0g/dl
Serum GOT and GPT: <100IU/L
Serum total bilirubin: <2.0mg/dl Serum creatinine: <= 1.5mg/dL
8.Written informed consent.
Key exclusion criteria
1.Synchronous or metachronous colorectal cancer.
2.History of hypersensitivity for capecitabine drug product component or fluorouracil.
3.Patients who need continuing use of warfarin potassium and phenytoin.
4.History of serious drug allergy (>= grade 3).
5.Patients with severe complication (such as ileus, interstitial lung disease, lung fibrosis, diabetes that is difficult to control, heart failure, renal failure, liver failure).
6.Female who are pregnant, nursing, suspected of being pregnant or hope to become pregnant during the study period
7.No birth-control.
8.HIV positive.
9.Not suitable for participating in the study for any other reason.
Target sample size
70
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
3-39-15 Showa-Machi, Maebashi, Gunma, JAPAN
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Osamu TOTSUKA |
Organization
Gunma University Graduate School of Medicine
Division name
Department of Thoracic and Visceral Organ Surgery
Zip code
Address
3-39-15 Showa-Machi, Maebashi, Gunma, JAPAN
TEL
027-220-7111
Homepage URL
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 | 10 | Month | 14 | 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
No longer recruiting
Date of protocol fixation
| 2008 | Year | 01 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 03 | 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
| 2011 | Year | 10 | Month | 14 | Day |
Last modified on
| 2011 | Year | 10 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007751
