UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004934 |
|---|---|
| Receipt number | R000005875 |
| Scientific Title | Feasibility study of adjuvant chemotherapy with FOLFOX(or XELOX) for 3 months followed by oral anticancer drug for 3 months in patients with completely resected colorectal cancer |
| Date of disclosure of the study information | 2011/02/01 |
| Last modified on | 2019/11/06 10:59:32 |
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Basic information
Public title
Feasibility study of adjuvant chemotherapy with FOLFOX(or XELOX) for 3 months followed by oral anticancer drug for 3 months in patients with completely resected colorectal cancer
Acronym
Feasibility study of Sequential chemotherapy with L-OHP-based therapy followed by oral anticancer drug in patients with completely resected colorectal cancer (JSWOG C2 study)
Scientific Title
Feasibility study of adjuvant chemotherapy with FOLFOX(or XELOX) for 3 months followed by oral anticancer drug for 3 months in patients with completely resected colorectal cancer
Scientific Title:Acronym
Feasibility study of Sequential chemotherapy with L-OHP-based therapy followed by oral anticancer drug in patients with completely resected colorectal cancer (JSWOG C2 study)
Region
| Japan |
Condition
Condition
Colorectal Cancer
Classification by specialty
| Hematology and clinical oncology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate safety of adjuvant chemotherapy with FOLFOX therapy(or XELOX therapy) for 3 months followed by capecitabine therapy for 3 months in patients with completely resected colorectal cancer
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
Frequency and Grade of peripheral neuropathy(CTCAE v4 and PNQ)
Key secondary outcomes
1)Proportion of completion in oxaliplatin base therapy
2)Proportion of completion in adjuvant chemotherapy
3)Disease free survival
4)Proportion of treatment selection
5)Adverse event
6)Compare FOLFOX to XELOX in efficacy or 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
mFOLFOX6 therapy(or XELOX therapy) for 3 months followed by capecitabine for 3 months
mFOLFOX6 therapy
Day1 L-OHP 85mg/m2,l-LV 200mg/m2
Day1 bolus 5FU 400mg/m2
Day1~2 Infusional 5FU 2400mg/m2
XELOX therapy
Day1 L-OHP 130mg/m2
Day1~14(b.i.d. at the end of meal) capecitabine 2000mg/m2/day
Capecitabine therapy
Day1~14(b.i.d. at the end of meal)
Capecitabine 2500mg/m2/day
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)histopathologically confirmed colorectal cancer.
2)StageIII(or high risk stageII) and R0 resection.
3)After resection, it is possible to begin the adjuvant chemotherapy within 8 weeks
4)Age of 20 years or older.
5)ECOG Performance status(PS) of 0-1.
6)No prior treatments with chemotherapy(contain adjuvant chemotherapy), radiation therapy, immune therapy
7)no severe organ failure
--White blood cell count >= 3,000/mm3 and <= 12,000/mm3
--Neutrophil count >= 1,500/mm3
--Platelet count >= 100,000/mm3
--AST(GOT) and ALT(GPT) <= 100IU/L
--Total bilirubin <= 2.0mg/dL
--serum creatinine <= 1.5mg/dL
8)Written informed consent will be obtained from each patient before enrollment.
Key exclusion criteria
1)a history of serious drug hypersensitivity or serious drug allergy.
2)active double cancer
3) women who are pregnant, lactating, or wish to become pregnant
4)a history of colorectal cancer
5)more than grade 1 (CTCAE v4.0) peripheral neuropathy
6)clinically significant heart disease
7) judged to be unsuitable for this trial due to clinically significant mental / psychological disease etc
8)clinically important infection or suspected infection in febrile patients.
9)diarrhea(watery) or diarrhea that interferes with daily activities for patients with a stoma.
10) dementia
11)diabetes with uncontrolled or accompanied neuropathy
12)judged to be ineligible by principal investigator for any other reason.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuki Yamashita |
Organization
Okayama Rosai Hospital
Division name
Surgery
Zip code
Address
1-10-25 Chikkomidori-machi,Okayama City,Okayama,Japan
TEL
086-262-0131
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuki Yamashita |
Organization
Okayama Rosai Hospital
Division name
Surgery
Zip code
Address
1-10-25 Chikkomidori-machi,Okayama City,Okayama,Japan
TEL
086-262-0131
Homepage URL
Sponsor or person
Institute
NPO Japan Southwest Oncology Research Support Organization(JSWOG)
Institute
Department
Personal name
Funding Source
Organization
NPO Japan Southwest Oncology Research Support Organization(JSWOG)
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
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 02 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
http://jswog.org/report.html
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
Completed
Date of protocol fixation
| 2010 | Year | 12 | Month | 15 | Day |
Date of IRB
| 2011 | Year | 01 | Month | 27 | Day |
Anticipated trial start date
| 2011 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2016 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2016 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 01 | Month | 24 | Day |
Last modified on
| 2019 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005875
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