UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001827
Receipt number 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 12:00:36

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments

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 or person

Institute

Tohoku University Translational Research Center

Institute

Department

Personal name



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

Value
https://center6.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