UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003672 |
|---|---|
| Receipt number | R000004328 |
| Scientific Title | Phase II study of adjuvant chemotherapy of OPTIMOX therapy (intermittent FOLFOX regimen) for Stage III colon cancer (including Rectosigmoid cancer). |
| Date of disclosure of the study information | 2010/06/01 |
| Last modified on | 2010/05/28 15:43:33 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Phase II study of adjuvant chemotherapy of OPTIMOX therapy (intermittent FOLFOX regimen) for Stage III colon cancer (including Rectosigmoid cancer).
Acronym
Triple 4 study
Scientific Title
Phase II study of adjuvant chemotherapy of OPTIMOX therapy (intermittent FOLFOX regimen) for Stage III colon cancer (including Rectosigmoid cancer).
Scientific Title:Acronym
Triple 4 study
Region
| Japan |
Condition
Condition
Colon cancer (including Rectosigmoid cancer)
Classification by specialty
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The primary end piont of this study is to assess the efficacy and safety of OPTIMOX therapy (intermittent FOLFOX regimen) as adjuvant chemotherapy for Stage III colon cancer including Rectosigmoid cancer.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
The incidence of oxaliplatin induced neuropathy.
Key secondary outcomes
The incidence of all adverse events (Excluding neuropathy).
Disease free survival (DFS)
Overall survival (OS)
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
Adjuvant chemotherapy
Oxaliplatin 85mg/m2/bi-week(day1)
l-LV 200 mg/m2/bi-week(day1)
5-FU/bolus 400mg/m2/bi-week bolus(day1)
5-FU/infusional 2400mg/m2/bi-week(day1-3)
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Histologically confirmed Colorectal adenocarcinoma and histological Stage III Colon cancer (including Rectosigmoid cancer).
2.Curative resection with D2 or more extensive lymph node dissection.
3.Resection of histological curability A was performed.
4.Age: 20-80 years old.
5.Performance status (ECOG):0-2
6.No prior chemotherapy and radiotherapy and immunotherapy.
7.Adequate organ function.
* WBC:3,000/mm3-12,000/mm3
* Neutrophil count <=1500/mm3.
* Platelet count<=;100,000/mm3.
Liver function tests
* AST (GOT) and ALT (GPT)>=;2.5*ULN.
* Total bilirubin>=;2.5*ULN.
Renal function test
* Serum creatinine>=;1.25*ULN.
8.Chemotherapy will be started within 8 weeks from operation.
9.Written informed consent.
Key exclusion criteria
1.Pregnant or nursing
2.Administering antithrobotic drug within 14 days
3.Medical history of allergy or hypersensitivity reactions.
4.Peripheral neuropathy (CTC AE v3.0 <= Grade1)
5.Active infection
6.Serious complications (renal failure or hepatic failure or heart failure)
7.Interstitial pnumonitis, pulmonary fibrosis or high-grade pulmonary emphysema.
8.Treated heart disease within 12 months
9.History of mental disturbances or cerebrovascular attack.
10.Watery diarrhea.
11.History of other colorectal cancer (including; sarcoma, carcinoid, lymphoma etc).
12.History of cancer (disease free interval was less than 10 years)
13.Double cancer.
14.Other conditions not suitable for this study
Target sample size
85
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Iwao Sasaki |
Organization
Tohoku University Graduate School of Medicine
Division name
Division of Biological-regulation and Oncology
Zip code
Address
1-1, Seiryo-machi, Aoba-ku, Sendai, 980-8574, JAPAN
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshinori Ando, Koh Miura |
Organization
Tohoku University Graduate School of Medicine
Division name
Division of Biological-regulation and Oncology
Zip code
Address
1-1, Seiryo-machi, Aoba-ku, Sendai, 980-8574, JAPAN
TEL
022-217-7205
Homepage URL
Sponsor or person
Institute
Tohoku University Graduate School of Medicine
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 | 06 | Month | 01 | 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 | 01 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 12 | 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 | 05 | Month | 28 | Day |
Last modified on
| 2010 | Year | 05 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004328
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
