UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010128 |
|---|---|
| Receipt number | R000011863 |
| Scientific Title | Safety of the oxaliplatin readministration by the desensitization for metastatic colorectal cancer patients having oxaliplatin allergy |
| Date of disclosure of the study information | 2013/02/28 |
| Last modified on | 2020/09/11 13:08:00 |
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Basic information
Public title
Safety of the oxaliplatin readministration by the desensitization for metastatic colorectal cancer patients having oxaliplatin allergy
Acronym
Safety of the oxaliplatin readministration by the desensitization for metastatic colorectal cancer patients having oxaliplatin allergy
Scientific Title
Safety of the oxaliplatin readministration by the desensitization for metastatic colorectal cancer patients having oxaliplatin allergy
Scientific Title:Acronym
Safety of the oxaliplatin readministration by the desensitization for metastatic colorectal cancer patients having oxaliplatin allergy
Region
| Japan |
Condition
Condition
Colorectal carcinoma
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
to evaluate the safety of the oxaliplatin readministration by the desensitization for metastatic colorectal cancer patients having oxaliplatin allergy
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the rate of oxaliplatin readministration without allergy
Key secondary outcomes
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
desensitization
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) Histopathologically confirmed colorectal adenocarcinoma
(2) Unresectable or recurrent colorectal cancer
(3) Prior chemotherapy history for metastatic colorectal cancer
(4) History of Grade2-3 oxaliplatin allergy,and reappearance Grade2-3 oxaliplatin allergy in spite of premedication with corticosteroids and antagonists of histamine receptors
(5) Treated with oxaliplatin-based chemotherapy
(6) What type of regimen
(7) Life expectancy estimated more than 2 months
(8) Aged over 20 years at the time of registration
(9) Performance status(ECOG) 0-2
(10) With or without measurable region
(11) Adequate organ function
(12) Grade1 toxicity for chemotherapy, radiotherapy or surgery
(13) Written informed consent
Key exclusion criteria
1 History of desensitization for oxaliplatin
2 history of oxaliplatin hypersensitivity Grade4
3 Uncontrollable diabetes mellitus
4 Regularly using steroid
5 Uncontrollable heart disease
6 Other severe complications such as renal failure liver failure and intestinal pneumonitis
7 Symptomatic CNS metastasis
8 Active bacterial or fungous infection
9 Massive pleural effusion or massive ascites
10 Active bleeding
11 Active double cancer
12 Patient evaluated to be inadequate by a attending doctor
13 Other conditions not suitable for this study
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kei Muro |
Organization
Aichi Cancer Center Hospital
Division name
Department of Clinical Oncology
Zip code
Address
1-1 Kanokoden, Chikusa-ku, Nagoya, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yukiya Narita |
Organization
Aichi Cancer Center Hospital
Division name
Department of Clinical Oncology
Zip code
Address
1-1 Kanokoden, Chikusa-ku, Nagoya, Japan
TEL
052-762-6111
Homepage URL
Sponsor or person
Institute
Aichi Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
Aichi Cancer Center Hospital, Department of Clinical Oncology
Organization
Division
Category of Funding Organization
Local Government
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 02 | Month | 28 | 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
Completed
Date of protocol fixation
| 2013 | Year | 02 | Month | 26 | Day |
Date of IRB
| 2013 | Year | 02 | Month | 26 | Day |
Anticipated trial start date
| 2013 | Year | 02 | Month | 28 | Day |
Last follow-up date
| 2019 | 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
| 2013 | Year | 02 | Month | 26 | Day |
Last modified on
| 2020 | Year | 09 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011863
