UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A feasibility study of adjuvant therapy with FOLFOX plus Ca/Mg for the patient with colorectal cancer
Title of the study (Brief title)	A feasibility study of adjuvant therapy with FOLFOX plus Ca/Mg for the patient with colorectal cancer(KSCC0903)
Region	Japan

Condition
Condition	Colorectal Cancer
Classification by specialty	Gastroenterology Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the safety of adjuvant treatment with a combination of FOLFOX plus Ca/Mg for the patient with colorectal cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2	Pragmatic
Developmental phase	Phase IV

Assessment
Primary outcomes	the rate of completion of treatment as planned
Key secondary outcomes	Safety (especially peripheral neuropathy, digestive symptom ) Quality of life Disease free survival Overall survival

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	FOLFOX4(L-OHP85mg/m2,l-LV100mg/m2x2, 5FU400mg/m2(bolus)x2, 5FU600mg/m2x2(civ)) or mFOLFOX6(L-OHP85mg/m2, l-LV200mg/m2, 5FU400mg/m2(bolus), 5FU2400mg/m2(civ)). Ca/Mg 0.8-1g (iv) x2 before and after L-OHP infusion Cycles of therapy are given every 2 weeks for 12 cycles
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.Written informed consent 2.Appropriate for the study at the physician's assessment 3.Histologically confirmed adenocarcinoma of the colon or rectum.(the tumor above the peritoneal reflection )(except appendix) 4.Histological high risk StageII and Stage III colorectal adenocarcinoma. 5.Tumor resection with D2orD3 lymph node dissection was performed. 6.Resection of histological curability A was performed 7.Aged 20<= years. 8.ECOG performance status of 0-1. 9.No prior chemotherapy and radiotherapy 10.Recovery of postoperative complications 11.Required baseline laboratory parameters (within 14 days before registration): WBC more than 3000 and WBC less than 12000/mm3 Neu more than 1,500/mm3 Plt more than 100,000/mm3 Hb more than 9.0g/dl T-Bil less than 2.0mg/dl AST,ALT within 2.5 times of normal limit of each hospital Cre less than 1.5mg/dl 12.Registration within 8 weeks after surgery
Key exclusion criteria	1.Patients who had received blood transfusion, blood products, or hematopoietic growth factors such as granulocyte-colony stimulating factor within 7 days prior to registration. 2.History of the severe hypersensitivity. 3.Sensory neuropathy. 4.Active other malignancies. 5.Active infection 6.History of mental disorder,central nerve disorder. 7.Watery stools or Grade 2 or more diarrhea 8.Requiring steroid drug 9.Pregnant or lactating woman 10.Co-mobility, such as interstitial lung disease, lung fibrosis, intestinal paralysis, ileus,uncontrolled diabetes, liver cirrhosis, viral hepatitis type B ,kidney failure, uncontrolled hypertension, history of cardiac infarction 11.History of the internal organ transplant 12.Hypercalcemia ,renal calculus 13.Requiring cardiac glycoside 14.High probability of recurrence 15.Not appropriate for the study at the physician's assessment
Target sample size	48

Research contact person
Name of lead principal investigator	Tadashi Nishimaki
Organization	University of the Ryukyus Faculty of Medicine
Division name	Department of Surgery Medicine
Address	207 Uehara, Nishiharacho, Nakagamigun, Okinawa, 903-0215, Japan
TEL	092-631-2920
Email	kscc2@cres-kyushu.or.jp

Public contact
Name of contact person	KSCC
Organization	Clinical Research Support Center Kyushu
Division name	KSCC
Address	3-1-1, Maidashi, Higashi-Ku, Fukuoka, Japan, 812-8582
TEL	092-631-2920
Homepage URL
Email	kscc2@cres-kyushu.or.jp

Sponsor
Institute	Kyushu Study group of Clinical Cancer
Institute
Department

Funding Source
Organization	Clinical Research Support Center Kyushu
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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

九州大学（福岡県） 貝塚病院（福岡県） 国立病院機構九州医療センター（福岡県） 公立学校共済組合九州中央病院（福岡県） 済生会福岡総合病院（福岡県） 新日鐵八幡記念病院（福岡県） 国立病院機構福岡東医療センター（福岡県） 社会保険田川病院（福岡県） 社会保険仲原病院（福岡県） 久留米大学（福岡県） 久留米大学医療センター（福岡県） 社会保険久留米第一病院（福岡県） 公立八女総合病院（福岡県） 福岡大学（福岡県） 済生会八幡総合病院（福岡県） 麻生飯塚病院（福岡県） 済生会唐津病院（佐賀県） 健康保険諫早総合病院（長崎県） 佐世保市立総合病院（長崎県） 長崎大学（長崎県） 白十字会　佐世保中央病院（長崎県） 国立病院機構長崎医療センター（長崎県） 春回会　井上病院（長崎県） 光晴会病院（長崎県） 長崎百合野病院（長崎県） 医理会　柿添病院（長崎県） 熊本大学（熊本県） 高野会　高野病院（熊本県） 済生会熊本病院（熊本県） 熊本赤十字病院（熊本県） 熊本中央病院（熊本県） 大分赤十字病院（大分県） 国立病院機構大分医療センター（大分県）　　 国立病院機構別府医療センター（大分県） 中津市立中津市民病院（大分県） 大分県立病院（大分県） 潤愛会　鮫島病院（鹿児島県） 鹿児島大学（鹿児島県） 鹿児島厚生連病院（鹿児島県） 鹿児島共済会南風病院（鹿児島県） 済生会川内病院（鹿児島県） 浦添総合病院（沖縄県） 中頭病院（沖縄県） 沖縄県立南部医療センター・こども医療センター（沖縄県） 琉球大学（沖縄県） 北部地区医師会病院（沖縄県） 豊見城中央病院（沖縄県） ハートライフ病院（沖縄県） 広島赤十字・原爆病院（広島県） 松山赤十字病院（愛媛県）

Other administrative information
Date of disclosure of the study information	2010 Year 07 Month 14 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 03 Month 30 Day
Anticipated trial start date	2010 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2010 Year 06 Month 04 Day
Last modified on	2017 Year 04 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004396