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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000001982
Receipt No. R000002419
Scientific Title Multicenter phase I trial of the preoperative UFT/LV medical treatment and radiotherapy for the resectable T3 and T2N1-2 rectum cancer
Date of disclosure of the study information 2009/05/19
Last modified on 2010/01/29

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Basic information
Public title Multicenter phase I trial of the preoperative UFT/LV medical treatment and radiotherapy for the resectable T3 and T2N1-2 rectum cancer
Acronym Phase I trial of the preoperative UFT/LV medical treatment and radiotherapy for the resectable T3 and T2N1-2 rectum cancer
Scientific Title Multicenter phase I trial of the preoperative UFT/LV medical treatment and radiotherapy for the resectable T3 and T2N1-2 rectum cancer
Scientific Title:Acronym Phase I trial of the preoperative UFT/LV medical treatment and radiotherapy for the resectable T3 and T2N1-2 rectum cancer
Region
Japan

Condition
Condition Rectal Cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We perform phase I trial to research recommended dose and safety of UFT for the operable T3 and T2N1-2 rectum cancer in the UFT/LV medical treatment and radiotherapy.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase I

Assessment
Primary outcomes The decision of maximal tolerated dose (MTD) and recommended dose (RD) of UFT
Safety (the degree and grade of the adverse event and the surgical complication)
Key secondary outcomes Antitumor effect (objective response rate)
The rate of pathological CR

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 Chemotherapy:
UFT:240, 300 mg/m2/day
LV:75 mg/body/day Day 1-28
Radiotherapy:
1.8 Gy/day, Day 1-5 every 7 days, 25 times, total 45Gy
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) The case of T3 and T2N1-2 rectum cancer proved for histopathology (Besides Rs)
(2) The first time chemotherapy case
(3) The case without the past of the radiation therapy
(4) The case without the high obstacle for the marrow, the liver, the kidney and cardiac function(judging from the laboratory data within 14 days before registration)
(5) The case without the ileus
(6) The case performance status (ECOG) is 0-1
(7) The case that survival time is expected to be more than three months from a treatment start day
(8) Age at the time of the consent acquisition is over 20 years old.
(9) Written informed consent
Key exclusion criteria (1) The case with a serious myelosuppression
(2) The case that it is clear to have pneumonitis, pulmonary fibrosis with a chest x-ray film, or the case having these anamneses
(3) The pleural or pericardial effusion requiring drainage (The case to need tube drainage or waste fluid by the puncture)
(4) The case with the double cancer (The cancer in the epithelium and the skin cancer are removed.)
(5) The infectious disease, the intestinal paralysis and the ileus
(6) Diarrhea (water-like mail)
(7) It is during treatment or a control poor diabetes case by continuous use of the insulin
(8) The case having a complication (heart failure, liver failure, renal failure)
(9) The brain metastasis case of the existence symptom
(10) The pregnant or nursing patients and patients who may be a pregnant
(11) The case with having experienced serious drug allergy in the past
(12) Exclude the patients who are recognized as inadequate patients by doctors with responsibility in this trial
Target sample size 6

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Kamigaki
Organization Kobe University Graduate School of Medicine
Division name Division of Gastrointestinal Surgery
Zip code
Address 7-5-1 Kusunoki-cho, Chuo-ku, Kobe city, Hyogo
TEL 078-382-5925
Email

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Kamigaki
Organization Kobe University Graduate School of Medicine
Division name Division of Gastrointestinal Surgery
Zip code
Address 7-5-1 Kusunoki-cho, Chuo-ku, Kobe city, Hyogo
TEL 078-382-5925
Homepage URL http://www.med.kobe-u.ac.jp/surg1/index.html
Email

Sponsor
Institute Division of Gastrointestinal Surgery,
Kobe University Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
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
2009 Year 05 Month 19 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 No longer recruiting
Date of protocol fixation
2009 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 04 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 05 Month 19 Day
Last modified on
2010 Year 01 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002419

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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