UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006742 |
|---|---|
| Receipt number | R000007966 |
| Scientific Title | Efficacy and Safety study of adjuvant therapy with capecitabine plus oxaliplatin (XELOX) for the Japanese patient with Stage III curative resection Colon cancer -Phase II study |
| Date of disclosure of the study information | 2011/11/20 |
| Last modified on | 2021/05/25 15:54:57 |
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Basic information
Public title
Efficacy and Safety study of adjuvant therapy with capecitabine plus oxaliplatin (XELOX) for the Japanese patient with Stage III curative resection Colon cancer -Phase II study
Acronym
Efficacy and Safety study of adjuvant therapy with XELOX for the Japanese patient with StageIII curative resection Colon cancer
Scientific Title
Efficacy and Safety study of adjuvant therapy with capecitabine plus oxaliplatin (XELOX) for the Japanese patient with Stage III curative resection Colon cancer -Phase II study
Scientific Title:Acronym
Efficacy and Safety study of adjuvant therapy with XELOX for the Japanese patient with StageIII curative resection Colon cancer
Region
| Japan |
Condition
Condition
Colon cancer
Classification by specialty
| Gastroenterology | Hematology and clinical oncology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Efficacy and Safety study of adjuvant therapy with capecitabine plus oxaliplatin (XELOX) for the Japanese patient with Stage III curative resection Colon cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
3 year disease free survival
Key secondary outcomes
Completion rate of treatment,Safety, Duration of administration of oxaliplatin, Incidence of Peripheral neuropathy and hand foot syndrome, Incidence and Survival of hand foot syndrome, dose intensity,Efficacy of Stage IIIa, IIIb
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Adjuvant chemotherapy with capecitabine plus oxaliplatin
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Histologically proved colon cancer(adenocarcinoma)
2) Stage III colon cancer or RS
3) >=D2 lymph node dissection
4) Pathological curability is A
5) >=20years-old
6) ECOG performance status 0-1
7) No prior chemotherapy or radiotherapy
8) Enough oral food intake possible
9) Adequate organ function
10) Able to start within 8 weeks after surgery
11) Written informed consent
Key exclusion criteria
1) Present with diarrhea
2) synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ
3) CTCAE v4.0>Grade1 of peripheral neuropathy
4) regular use of insulin
5) uncontrollable congestive heart failure, angina,hypertension, arrhythmia
6) Severe mental disease
7) active infection
8) Pregnant or breast-feeding women
9) Woman might be pregnant
10) Inadequate physical condition, as diagnosed by primary physician
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | katsuki |
| Middle name | |
| Last name | Danno |
Organization
Minoh City Hospital
Division name
Department of Surgery
Zip code
562-0014
Address
5-7-1 Kayano, Minoh, Osaka 562-0014, Japan
TEL
072-728-2001
k.danno@minoh-hp.jp
Public contact
Name of contact person
| 1st name | Mamoru |
| Middle name | |
| Last name | Uemura |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Surgery
Zip code
565-0871
Address
2-2 Yamadaoka, Suita, Osaka 565-0871,Japan
TEL
06-6879-3251
Homepage URL
muemura@gesurg.med.osaka-u.ac.jp
Sponsor or person
Institute
Multicenter Study Group of Osaka (MCSGO), Colorectal Cancer Treatment Group
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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The ethics committee of Osaka University
Address
2-15 Yamadaoka Suita-city Osaka,Japan
Tel
06-6879-5685
rinri@hp-crc.med.osaka-u.ac.jp
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
| 2011 | Year | 11 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
195
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
No longer recruiting
Date of protocol fixation
| 2011 | Year | 11 | Month | 09 | Day |
Date of IRB
| 2011 | Year | 11 | Month | 09 | Day |
Anticipated trial start date
| 2011 | Year | 11 | Month | 10 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 11 | Month | 17 | Day |
Last modified on
| 2021 | Year | 05 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007966
| Research Plan | |
|---|---|
| Registered date | File name |
| 2016/07/06 | StageⅢ結腸癌治癒切除例に対する術後補助化学療法XELOX療法の有効性・安全性の検討－PhaseⅡ試験－.zip |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
