UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II study of neoadjuvant chemotherapy with CPT-11 and S-1 for locally advanced colorectal cancer with lymph node metastases.
Title of the study (Brief title)	Phase II study of neoadjuvant chemotherapy with CPT-11 and S-1 for locally advanced colorectal cancer with lymph node metastases.
Region	Japan

Condition
Condition	locally advanced colorectal cancer with lymph node metastases
Classification by specialty	Gastroenterology Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The objective of this study was to explore the antitumor effect (response rate), relapse free survival (RFS), overall survival(OS), resection rate, safety and curative resection rate.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Response rate
Key secondary outcomes	Relapse free survival of 3 years Overall survival Resection rate Safty Curative resection rate

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 80mg/m2/day for 14 days plus CPT-11 100mg/m2 on day 1 and 15 every 28 days is administered for 2 course. After treatment, response rate is evaluated. Surgical operation is performed.
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	1)colorectal cancer proven histologically 2)locally advanced colorectal cancer with lymph node metastases 3)with measurable lesion at primary tumor 4)without ileus 5)without prior chemotherapy 6)without radiation therapy 7)age 20-80 years patients 8)Eastern Cooperative Oncology performance status (PS) 0-1 9)survival period more than 3 months 10)sufficient function og important organs a. WBC: >=4,000/mm3 and 12,000/mm3 b. Neutrophil: >=2,000/mm3 c. Platelet: >=100,000/mm3 d. Hemoglobin: >=9.0g/dL e. AST, ALT: <100IU/L f. sT. bil:<=1.5mg/dL g. sCreatinin: <=1.2mg/dL h. nomal ECG 11)written informed consent 12)with ability of oral intake
Key exclusion criteria	1)with serious interstitial lung fibrosis 2)with active double cancer 3)with active infection ,intestinal paralysis or ileus 4)with water solubility diarrhea 5)with uncontrolled diabetes mellitus 6)with serious complication (e.g. heart failure, hepatic failure, kidney failure) 7)receiving Flucytosine 8)pregnant or lactating women, women who are capable of pregnancy or intend to get pregnant 9with previous serious medical illness or allergy for drugs 10)with brain metastasis or treated for brain metastasis 11)with myelosupression 12)with pleural effusion or abdominal dropsy 13)with jaundice 14)receiving steroids 15)except referred to above, physician in charge of this trial gave a diagnosis the patient who can not joint this trail for the safety
Target sample size	35

Research contact person
Name of lead principal investigator	Katsuyoshi Hatakeyama
Organization	Niigata University Medical & Dental Hospital
Division name	President of a hospital
Address	1-754, Asahimachi-dori, Chuo-ku, Niigata City 951-8520, Niigata Prefecture, JAPAN
TEL	025-227-2228
Email

Public contact
Name of contact person	Yasumasa Takii
Organization	Niigata Cancer Center Hospital
Division name	Surgery
Address	2-15-3, Kawagishi-chou, Chuo-ku, Niigata City 951-8520, Niigata Prefecture, JAPAN
TEL	025-266-5111
Homepage URL
Email	takii@niigata-cc.jp

Sponsor
Institute	Niigata Colorectal cancer Chemotherapy Study Group (NCCSG)
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Niigata Colorectal cancer Chemotherapy Study Group
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	2009 Year 02 Month 10 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2005 Year 08 Month 08 Day
Anticipated trial start date	2005 Year 09 Month 01 Day
Last follow-up date	2014 Year 04 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	Published
URL releasing results
Results
Other related information

Management information
Registered date	2009 Year 02 Month 09 Day
Last modified on	2019 Year 02 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000002047