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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009764
Receipt No. R000011441
Scientific Title Phase II study of neoadjuvant chemotherapy with L-OHP and S-1 for locally advanced rectal cancer (NCCSG-09)
Date of disclosure of the study information 2013/01/15
Last modified on 2019/02/03

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Basic information
Public title Phase II study of neoadjuvant chemotherapy with L-OHP and S-1 for locally advanced rectal cancer (NCCSG-09)
Acronym Phase II study of neoadjuvant chemotherapy locally advanced rectal cancer (NCCSG-09)
Scientific Title Phase II study of neoadjuvant chemotherapy with L-OHP and S-1 for locally advanced rectal cancer (NCCSG-09)
Scientific Title:Acronym Phase II study of neoadjuvant chemotherapy locally advanced rectal cancer (NCCSG-09)
Region
Japan

Condition
Condition locally advanced rectal cancer
Classification by specialty
Hematology and clinical oncology 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, curative resection rate, and rate of sphincter-preservation of these two drugs, which combined neoadjuvant chemotherapy with L-OHP and S-1 in patients with locally advanced rectal cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Response rate
Key secondary outcomes Relapse free survival, Overall survival, Resection rate, Safety, Curative resection rate, histological response evaluation, rate of sphincter-preservation

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 Maneuver
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) Main lesion of the tumor is located at the Ra or Rb
2) Histologically confirmed Rectum adenocarcinoma
3) Clinical stage T3, any N, or T4, any N
4) Possigle to R0 resection
5) without metastases
6) without prior anti-tumor therapy (radiation therapy, chemotherapy and hormone therapy)
7) with measurable lesion
8) without ileus
9) age of 20-80 years
10) Eastern Cooperative Oncology Group performance status (PS) 0-1
11) survival period more than 3 months
12) adequate function of important prgans
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. bBil: <=2.0mg/dL
7. cCreatinin: <=1.0mg.DL or creatinin clearance level >= 60mi/min
13) written informed concent
14) 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) were systemically-administered of steroids
15) with jaundice
16) 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 Yasumasa Takii
Organization Niigata Colorectal cancer Chemotherapy Study Group (NCCSG)
Division name Niigata Cancer Center Hospital
Zip code
Address Kawagishicho-2, Chuuo-ku, Niigata City, Niigata Pref.
TEL 025-266-5111
Email takii@niigata-cc.jp

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 Kawagishicho-2, Chuuo-ku, Niigata City, Niigata Pref.
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 non
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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 新潟県立がんセンター新潟病院、新潟大学医師学総合病院消化器一般外科学分野、済生会新潟第二病院、新潟市民病院、日本歯科大学新潟歯学部、新潟県立吉田病院、新潟県立中央病院、厚生連長岡中央総合病院、長岡赤十字病院、新潟県立坂町病院、厚生連村上総合病院、厚生連豊栄病院、新津医療センター、立川総合病院、柏崎総合医療センター、山形県立中央病院

Other administrative information
Date of disclosure of the study information
2013 Year 01 Month 15 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
2013 Year 01 Month 12 Day
Date of IRB
Anticipated trial start date
2013 Year 01 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 01 Month 12 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=R000011441

Research Plan
Registered date File name
2016/07/27 実施計画書_NCCSG-09_v0.3_120827 完成版.doc

Research case data specifications
Registered date File name

Research case data
Registered date File name


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