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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000006541
Receipt No. 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

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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
Email

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
Email

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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007751

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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