UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II study of neoadjuvant chemotherapy with L-OHP 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 L-OHP 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. of these two drugs, which combined neoadjuvant chemotherapy with L-OHP and S-1 in patients with advanced colorectal cancer.
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, histological response evaluation

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 L-OHP 100mg/m2 on day 1 every 21 days is administered for 3 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)histologically confirmed colorectal cancer 2)locally advanced colorectal cancer with lymph node metastases 3)with measurable lesion 4)without ileus 5)without prior chemotherapy 6)without radiation therapy 7)age of 20-80 years 8)Eastern Cooperative Oncology Group performance status (PS) 0-1 9)survival period more than 3 months 10)adequate function of important organs 1. WBC: >=3,000/mm3 and 12,000/mm3 2. Neutrophil: >=1,500/mm3 3. Platelet: >=100,000/mm3 4. Hemoglobin: >=9.0g/dL 5. AST, ALT: <100IU/L 6. sBil:<=2.0mg/dL 7. sCreatinin: <=1.0mg/dL or creatinine clearance level >= 60ml/min 11)written informed consent 12)with ability of oral intake
Key exclusion criteria	1) with sensory neuropathy 2) with active double cancer 3) had active infection disease (over 38.0 degree) 4) with sever diarrhea 5) had serious complication (e.g. interstitialpneumonia, or pulmonary fibrosis, kidney injury, hepatic failure, uncontrolled diabetes mellitus, uncontrolled hypertension) 6) with previous serious drug hyperseneitivity 7) with significant abnormal electrocardiogram or cardiovascular disease (e.g. heart failure, myocardial infarction, angina pectoris) 8) with myelosupression 9) with chickenpox 10) had pleural effusion or ascites which need therapy 11) receiving Flucytosine 12) Pregnant or lactating women, women who are capable of pregnancy, intend to get pregnant or men who want to get their partners pregnant 13) had a previous serious drug allergies 14) .clinical evidence of CNS metastases or had a history of brain metastasis 15) were systemically-administered of steroids 16) with jaundice 17) 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	Toshihumi Wakai
Organization	Niigata University Medical and Dental Hospital
Division name	professor
Address	Asahimachi-dori 1-754, Chuo-ku, Niigata, 951-8520
TEL	025-227-2228
Email	wakait@med.niigata-u.ac.jp

Public contact
Name of contact person	Yasumasa Takii
Organization	Niigata Cancer Center Hospital
Division name	Department of Surgery
Address	Kawagishi-cho 2-15-3, Chuo-ku, Niigata, 951-8566
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 (NCCSG)
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	新潟大腸癌化学療法研究会 (NCCSG)

Other administrative information
Date of disclosure of the study information	2010 Year 04 Month 26 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2009 Year 07 Month 24 Day
Anticipated trial start date	2010 Year 04 Month 01 Day
Last follow-up date	2016 Year 03 Month 01 Day
Date of closure to data entry	2019 Year 03 Month 01 Day
Date trial data considered complete	2019 Year 06 Month 01 Day
Date analysis concluded	2019 Year 08 Month 01 Day

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2010 Year 04 Month 24 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=R000004287