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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000001827
Receipt No. R000002206
Scientific Title Double-blind Randomized Multi-center Trial Regarding the Effects of Solution for Gemcitabine on Frequency and Degree of Vascular Pain in Patients with Cancer
Date of disclosure of the study information 2009/03/31
Last modified on 2010/04/02

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Basic information
Public title Double-blind Randomized Multi-center Trial Regarding the Effects of Solution for Gemcitabine on Frequency and Degree of Vascular Pain in Patients with Cancer
Acronym Double-blind Randomized Multi-center Trial Regarding the Effects of Solution for Gemcitabine on Frequency and Degree of Vascular Pain in Patients with Cancer (TUTRCDC001)
Scientific Title Double-blind Randomized Multi-center Trial Regarding the Effects of Solution for Gemcitabine on Frequency and Degree of Vascular Pain in Patients with Cancer
Scientific Title:Acronym Double-blind Randomized Multi-center Trial Regarding the Effects of Solution for Gemcitabine on Frequency and Degree of Vascular Pain in Patients with Cancer (TUTRCDC001)
Region
Japan

Condition
Condition Non-small-cell lung cancer, Bile duct cancer, Pancreatic cancer
Classification by specialty
Hepato-biliary-pancreatic medicine Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To study the effects of gemcitabine solutions, saline and 5% of glucose solution, on the frequency and degree of vascular pain in patients with non-small-cell lung cancer, bile duct cancer, or pancreatic cancer
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Frequency and degree of vascular pain
Key secondary outcomes Adverse effects equal to or more than Grade 2 in CTCAEv3.0

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Active
Stratification NO
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Patients with cancer are randomized to gemcitabine diluted with saline or 5% glucose solution at the first time after enrollment. Furthermore, those who are treated with gemcitabine diluted with saline at the first time will be treated with gemcitabine with 5% glucose solution at the next time by cross-over fashion.
Interventions/Control_2 Patients with cancer are randomized to gemcitabine diluted with saline or 5% glucose solution at the first time after enrollment. Furthermore, those who are treated with gemcitabine diluted with 5% of glucose solution at the first time will be treated with gemcitabine with saline solution at the next time by cross-over fashion.
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) The diagnosis of non-small cell lung cancer was confirmed with histological or cytological examination. However, the diagnosis of pancreatic cancer and bile duct cancer can be confirmed with clinical finding including radiological methods without histological or cytological diagnosis;
(2) Scheduled chemotherapy with gemcitabine;
(3) Good performance status: a performance status (PS) of 0-2 according to the Eastern Cooperative Oncology Group (ECOG) scale;
(4) Informed consent to receive chemotherapy with gemcitabine and enrollment into this study were obtained;
Key exclusion criteria (1) Without active interstitial pneumonitis or uncontrollable lung fibrosis
(2) No concurrent thoracic radiotherapy during chemotherapy;
(3) Without uncontrollable infectious disease;
(4) No severe complication including heart failure, renal insufficiency, liver dysfunction, hemorrhagic digestive tract ulcer, ileus, and uncontrollable diabetic mellitus
(5) Without pregnancy or nurse
(6) No uncontrollable mental disease
(7) No inappropriate patient judged by a medical doctor for enrollment into this study
Target sample size 90

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyasu Yasuda
Organization Tohoku University Translational Research Center
Division name Department of clinical application
Zip code
Address 1-1 Seiryo-machi, Aoba-ku, Sendai, 980-8574, Japan
TEL 022-717-7122
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hiroki Nagai
Organization Kyoto University Hospital
Division name Department of Respiratory Medicine
Zip code
Address 54 Shogoin-Kawahara-cho, Sakyo-ku, Kyoto, 606-8507, Japan
TEL 075-751-3830
Homepage URL http://www.hosp.tohoku.ac.jp/tr_center/DC/index.html
Email hirokiwithe@yahoo.co.jp

Sponsor
Institute Tohoku University Translational Research Center
Institute
Department

Funding Source
Organization Ministry of Education, Science and Culture (19689018, and 17790524) of the Japanese government, and The Kanae Foundation for the Promotion of Medical Science
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Tohoku University Hospital, Kyoto University Hospital
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
2009 Year 03 Month 31 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
2009 Year 02 Month 16 Day
Date of IRB
Anticipated trial start date
2009 Year 03 Month 01 Day
Last follow-up date
2011 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 03 Month 31 Day
Last modified on
2010 Year 04 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002206

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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