UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003529 |
|---|---|
| Receipt number | R000004287 |
| Scientific Title | Phase II study of neoadjuvant chemotherapy with L-OHP and S-1 for locally advanced colorectal cancer with lymph node metastases |
| Date of disclosure of the study information | 2010/04/26 |
| Last modified on | 2019/02/03 21:24:47 |
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Basic information
Public title
Phase II study of neoadjuvant chemotherapy with L-OHP and S-1 for locally advanced colorectal cancer with lymph node metastases
Acronym
Phase II study of neoadjuvant chemotherapy with L-OHP and S-1 for locally advanced colorectal cancer with lymph node metastases
Scientific Title
Phase II study of neoadjuvant chemotherapy with L-OHP and S-1 for locally advanced colorectal cancer with lymph node metastases
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Toshihumi Wakai |
Organization
Niigata University Medical and Dental Hospital
Division name
professor
Zip code
Address
Asahimachi-dori 1-754, Chuo-ku, Niigata, 951-8520
TEL
025-227-2228
wakait@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasumasa Takii |
Organization
Niigata Cancer Center Hospital
Division name
Department of Surgery
Zip code
Address
Kawagishi-cho 2-15-3, Chuo-ku, Niigata, 951-8566
TEL
025-266-5111
Homepage URL
takii@niigata-cc.jp
Sponsor or person
Institute
Niigata Colorectal cancer
Chemotherapy Study Group (NCCSG)
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Partially 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
| 2009 | Year | 07 | Month | 24 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004287
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