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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010128
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Aichi Cancer Center Hospital
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011863

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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