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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004934
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute NPO Japan Southwest Oncology Research Support Organization(JSWOG)
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005875

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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