UMIN-CTR Clinical Trial

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