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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000004590
Receipt No. R000005472
Scientific Title North Japan multicenter phase II study of oxaliplatin-containing regimen as adjuvant chemotherapy for stage III colon cancer(NORTH/HGCSG1003 study)
Date of disclosure of the study information 2011/01/15
Last modified on 2014/05/19

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Basic information
Public title North Japan multicenter phase II study of oxaliplatin-containing regimen as adjuvant chemotherapy for stage III colon cancer(NORTH/HGCSG1003 study)
Acronym North Japan multicenter phase II study of oxaliplatin-containing regimen as adjuvant chemotherapy for stage III colon cancer(NORTH/HGCSG1003 study)
Scientific Title North Japan multicenter phase II study of oxaliplatin-containing regimen as adjuvant chemotherapy for stage III colon cancer(NORTH/HGCSG1003 study)
Scientific Title:Acronym North Japan multicenter phase II study of oxaliplatin-containing regimen as adjuvant chemotherapy for stage III colon cancer(NORTH/HGCSG1003 study)
Region
Japan

Condition
Condition Colon Cancer
Classification by specialty
Gastroenterology Hematology and clinical oncology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 3-year DFS for colon cancer(included rectosigmoid cancer) of the oxaliplatin combined adjuvant chemotherapy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes three-year disease-free survival rate
Key secondary outcomes 1)overall survival
2)relative dose intensity
3)adverse event

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Oxaliplatin 85mg/m2 day1
Fluorouracil bolus infusion 400mg/m2 day1&2
Fluorouracil continuous infusion 600mg/m2 day1&2(22 hours)
Levofolinate 100mg/m2 day1&2
Or
Oxaliplatin 85mg/m2 day1
Fluorouracil bolus infusion 400mg/m2 day1
Fluorouracil continuous infusion 2, 400mg/m2 day1(46 hours)
Levofolinate 200mg/m2 day1
Treatment is repeated 12 courses every 2 weeks.
Interventions/Control_2
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

Not applicable
Gender Male and Female
Key inclusion criteria 1)Histologically confirmed colon cancer(included rectosigmoid cancer).
2)Histologically proven stage III(any T N1-2 M0) colon cancer. Patients had to have undergo complete resection of primary tumor without gross or microscopic evidence of residual disease.
3)The chemotherapy in this study in order to start treatment within 8 weeks after surgery.
4)Age of 20 years or older
5)Eastern Cooperative Oncology Group(ECOG) performance-status of 0-2.
6)Carcino-embryogenic antigen(CEA) < 10 ng/mL
7)No previous chemotherapy(included adjuvant chemotherapy), immunotherapy or radiotherapy.
8)Needs adequate organ function(bone-marrow, liver renal function)
i)absolute neutrophil count > 1,500/microL
ii)plateles >= 100,000/microL
iii)serum creatinine <= 1.5mg/dL
iv)total bilirubine, AST, ALT < 2 times the upper limit of the normal range
9)Written informed consent obtained prior to study entry
Key exclusion criteria 1)Multiple cancer patient
2)Patients who had other cancer within 5 years.
3)Pregnant or lactating women.
4)Patients who had colorectal cancer excluded mucosal cancer.
5)Peripheral sensory neuropathy or Paresthesia(CTCAE v4.0 >= Grade 1).
6)Uncontrolled congestive heart failure or angina pectoris, or hypertension or arrhythmia.
7)History of significant neurologic or psychiatric disorders.
8)Active infection.
Target sample size 270

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshito Komatsu
Organization Hokkaido University Hospital Cancer Center
Division name Department of Cancer Chemotherapy
Zip code
Address North 15, West 5, Kita-ku, Sapporo, Hokkaido, Japan
TEL 011-716-1161
Email ykomatsu@med.hokudai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naoki Nishimoto
Organization Hokkaido Organization for Translational Research(HTR)
Division name Department of Clinical Trial Management
Zip code
Address North 15, West 5, Kita-ku, Sapporo, Hokkaido, Japan
TEL 011-706-7478
Homepage URL
Email nishimot@med.hokudai.ac.jp

Sponsor
Institute NPO Hokkaido Gastrointestinal Cancer Study Group (HGCSG)
Institute
Department

Funding Source
Organization NPO Hokkaido Gastrointestinal Cancer Study Group (HGCSG)
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

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 北海道大学病院

Other administrative information
Date of disclosure of the study information
2011 Year 01 Month 15 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 Main results already published
Date of protocol fixation
2010 Year 09 Month 08 Day
Date of IRB
Anticipated trial start date
2010 Year 09 Month 01 Day
Last follow-up date
2018 Year 08 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 11 Month 19 Day
Last modified on
2014 Year 05 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005472

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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