UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004590 |
|---|---|
| Receipt number | 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 14:34:08 |
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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
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
nishimot@med.hokudai.ac.jp
Sponsor or person
Institute
NPO Hokkaido Gastrointestinal Cancer Study Group (HGCSG)
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005472
