UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010888 |
|---|---|
| Receipt number | R000012743 |
| Scientific Title | Multidisciplinary team approach in management of Regorafenib toxicities for patients with metastatic colorectal cancer: Multi-institutional joint research in Shizuoka |
| Date of disclosure of the study information | 2013/06/06 |
| Last modified on | 2013/06/06 00:18:17 |
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Basic information
Public title
Multidisciplinary team approach in management of Regorafenib toxicities for patients with metastatic colorectal cancer: Multi-institutional joint research in Shizuoka
Acronym
T-ReX
Scientific Title
Multidisciplinary team approach in management of Regorafenib toxicities for patients with metastatic colorectal cancer: Multi-institutional joint research in Shizuoka
Scientific Title:Acronym
T-ReX
Region
| Japan |
Condition
Condition
Metastatic colorectal cancer
Classification by specialty
| Hematology and clinical oncology | Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Multidisciplinary team approach in management of regorafenib toxicities for patients with metastatic colorectal cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Reduce the regorafenib toxicities by multidisciplinary team approach.
Key secondary outcomes
1) Toxicities
2) Dose intensity
3) Response rate, Progression-free survival
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
Reduce the regorafenib toxicities
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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Age > and 18 years old
2) Histological proven colon carcinoma
3) Patients had to have received standard therapies(fl uoropyrimidine,oxaliplatin, irinotecan, and bevacizumab;and cetuximab or panitumumab for patients who had KRAS wild-type tumours) and to have disease progression.
4) There is not adaptation of the radical operation.
5) ECOG-PS: 0 or 1
6) Patients want to be treated with regorafenib.
7) No prior treatment of regorafenib
8) No severe skin toxicity
9) life expectancy of at least
12 weeks
10) Adequate organ functions defined as indicated below
(1)neutrophil >= 1,500 /mm3
(2)Plt >= 100,000 /mm3
(3) T.Bil <= 1.5 mg/dL
(4) AST(GOT) , ALT(GPT) <= 100 IU/L
(5) Cr < 1.5 mg/dL
(6) Urine protein <= 2+
11) Written informed consent
Key exclusion criteria
1) No Hepatitis virus infection
2) No liver cirrhosis
3) No use of warfarin regularly
4) Patient with active double cancer (synchronous double cancer and metachronous double cancer), excluding carcinoma in situ (lesions equal to intraepithelial or intramucosal cancer) judged to have been cured with local treatment.
5) No chronic infection
6) Patient with severe complications, such as paralytic ileus, bowel obstruction, interstitial pneumonitis, pulmonary fibrosis, or uncontrollable diabetes mellitus, arrhythmias, heart failure, liver cirrhosis, and active hepatitis)
7) Pregnant or nursing patient or with intent to bear baby
8) Exclude the patients who are recognized as inadequate patients by doctors with responsibility in this trial.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keisei Taku |
Organization
Shizuoka General Hospital
Division name
Division of Medical Oncology
Zip code
Address
4-27-1 Kitaandou, Aoi-ku, Shizuokashi, Shizuoka 420-8527 Japan
TEL
054-247-6111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keisei Taku |
Organization
Shizuoka General Hospital
Division name
Division of Medical Oncology
Zip code
Address
4-27-1 Kitaandou, Aoi-ku, Shizuokashi, Shizuoka 420-8527 Japan
TEL
054-247-6111
Homepage URL
http://www.shizuoka-pho.jp/sogo/
Sponsor or person
Institute
Shizuoka General Hospital
Institute
Department
Personal name
Funding Source
Organization
Shizuoka Prefectural Hospital Organization
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
静岡県立総合病院 静岡市立静岡病院 藤枝市立総合病院
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 06 | Month | 06 | 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
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
Enrolling by invitation
Date of protocol fixation
| 2013 | Year | 06 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 06 | Month | 06 | Day |
Last follow-up date
| 2015 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 05 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 06 | Month | 06 | Day |
Last modified on
| 2013 | Year | 06 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012743
