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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001698
Receipt No. R000002047
Scientific Title Phase II study of neoadjuvant chemotherapy with CPT-11 and S-1 for locally advanced colorectal cancer with lymph node metastases.
Date of disclosure of the study information 2009/02/10
Last modified on 2019/02/03

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Basic information
Public title Phase II study of neoadjuvant chemotherapy with CPT-11 and S-1 for locally advanced colorectal cancer with lymph node metastases.
Acronym Phase II study of neoadjuvant chemotherapy with CPT-11 and S-1 for locally advanced colorectal cancer with lymph node metastases.
Scientific Title Phase II study of neoadjuvant chemotherapy with CPT-11 and S-1 for locally advanced colorectal cancer with lymph node metastases.
Scientific Title:Acronym 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
1st name
Middle name
Last name Katsuyoshi Hatakeyama
Organization Niigata University Medical & Dental Hospital
Division name President of a hospital
Zip code
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
1st name
Middle name
Last name Yasumasa Takii
Organization Niigata Cancer Center Hospital
Division name Surgery
Zip code
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)

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
2009 Year 02 Month 10 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
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
2005 Year 08 Month 08 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000002047

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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