UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase I/II study of the combination of Oxaliplatin and S-1 in patients with advanced/recurrent colorectal cancer
Title of the study (Brief title)	SOX
Region	Japan

Condition
Condition	unresectable advanced/recurrent colorectal cancer
Classification by specialty	Gastroenterology Hematology and clinical oncology Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To determine the maximum tolerated dose (MTD) and the recommended dose (RD) of L-OHP combined with S-1 in patients with advanced/recurrent colorectal cancer, and to evaluate safety and clinical response with this therapy
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Phase I,II

Assessment
Primary outcomes	Step1:safety;adverse events Step2:Disease control rate
Key secondary outcomes	Step1:Eficacy (response rate(CR+PR),disease control rate, survival Step2: Safety, Response rate, 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	S-1 is administered orally at the dose of 40mg/m2 twice a day for 21 days, followed by 7-14 days rest. L-OHP is administered intravenously biweekly(day 1 and 15). On 2nd steps L-OHP is administered with RD intravenously biweekly more than 2 courses. The doses of L-OHP are 70mg/m2 for level 1, 85mg/m2 for level 2, and 55mg/m2 for level 0.
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	75 years-old >
Gender	Male and Female
Key inclusion criteria	1) With histologically or cytologically confirmed colorectal cancer 2) unresectable disease 3) Patients who have measurable lesions with RECIST criteria 4) Previous treatment with one regimens is allowed. At least 4 weeks interval from the last administration of previous chemotherapy 5) Age 20 to 74 years. 6) PS 0-1(ECOG). 7) Life-expectancy is more than 3 months 8) Adequate organ functions (bone marrow, liver, heart, lung, kidney etc.). Patients are required to satisfy all of the next-mentioned criteria: WBC > 4000/mm3 and <12000/mm3, Granulocyte count > 2000/mm3, Platelet count > 100,000/mm3, Hb > 9.0 g/dl AST & ALT < * 2.5 upper normal limit, Total bilirubin < 1.5mg/dl Serum creatinine < upper normal limit Cockroft-Gault CCr > 50ml/min 9) Written informed consent prior to the enrollment of the study. 10) adequate oral intake
Key exclusion criteria	1) during flucytosine medication 2) Active infection or inflammation 3) Uncontrolled severe Diabtes 4) patient severe medical condition 5) patient with interstitial pneumonitis or the history 6) patient with active gastrointestinal bleeding 7) patient with severe neurotoxicity 8) patient with active chicken pox 9) patient with metastasis of CNS 10) patient with other concurrent malignancy affecting on survival or adverse events 11) pregnant or nursing patient or with intent to bear baby 12) patient with allergic history to drug 13) patient with massive effusion of massive ascites 14) patient evaluated to be inadequate by a attending doctor
Target sample size	42

Research contact person
Name of lead principal investigator	Shigemi Matsumoto
Organization	Kyoto University Hospital
Division name	Outpatient Oncology Unit
Address	54 Shogoinkawahara-cho, Sakyo-ku, kyoto 606-8507, Japan
TEL	075-751-4770
Email

Public contact
Name of contact person	Shigemi Matsumoto
Organization	Kyoto University Hospital
Division name	Outpatient Oncology Unit
Address	54 Shogoinkawahara-cho, Sakyo-ku, kyoto 606-8507, Japan
TEL	075-751-4770
Homepage URL
Email	motocame@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Outpatient Oncology Unit Kyoto University Hospital
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	JAPAN

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

Other administrative information
Date of disclosure of the study information	2006 Year 07 Month 04 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2006 Year 03 Month 23 Day
Anticipated trial start date	2006 Year 05 Month 01 Day
Last follow-up date	2009 Year 03 Month 01 Day
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	2006 Year 07 Month 04 Day
Last modified on	2018 Year 10 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000000526