UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001483 |
|---|---|
| Receipt number | R000001796 |
| Scientific Title | Phase I study of oral S-1 plus Gemcitabine and concurrent radiotherapy in patients with locally advanced pancreatic cancer |
| Date of disclosure of the study information | 2008/11/06 |
| Last modified on | 2014/05/06 09:34:39 |
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Basic information
Public title
Phase I study of oral S-1 plus Gemcitabine and concurrent radiotherapy in patients with locally advanced pancreatic cancer
Acronym
Phase I study of oral S-1 plus Gemcitabine and concurrent radiotherapy in patients with locally advanced pancreatic cancer
Scientific Title
Phase I study of oral S-1 plus Gemcitabine and concurrent radiotherapy in patients with locally advanced pancreatic cancer
Scientific Title:Acronym
Phase I study of oral S-1 plus Gemcitabine and concurrent radiotherapy in patients with locally advanced pancreatic cancer
Region
| Japan |
Condition
Condition
Locally advanced pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Our purposes are to evaluate the safety and feasibility and to determine recommended dose of oral S-1 plus Gemcitabine and concurrent radiotherapy in patients with locally advanced pancreatic cancer.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
safety
feasibility
maximum-tolerated dose
recommended dose
Key secondary outcomes
response rate at 4 weeks after accomplishment of whole treatment
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 | Maneuver |
Interventions/Control_1
Radiation: 1.8 Gy x 28 fr
S1: 60-80mg/sq x 28 days (synchronized with Radiation)
GEM: 200-300mg/sq x 6 fr(d1,8,15,22,29,36)
Level 0: S1(60mg/sq)+GEM(200mg/sq)
Level 1: S1(80mg/sq)+GEM(200mg/sq)
Level 2: S1(80mg/sq)+GEM(300mg/sq)
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)A patient who has been diagnosed pancreatic cancer by diagnostic images and has been proven (or has a schedule for being proven) pancreatic adenocarcinoma histologically.
2)Locally advanced pancreatic cancer;
a)UICC stage II with portal or SMV invasion
b)UICC stage III
3)No prior operation, chemotherapy or radiotherapy
4)ECOG performance status of 0 or 1
5)Adequate hematologic, cardiac, pulmonary, hepatic and renal function
6)Total bilirubin level is less or equal 3.0mg/dL.
7)Written informed consent
Key exclusion criteria
1)Consciousness disorder
2)NYHA Class of II, III or IV
3)Interstitial pneumonia or pulmonary fibrosis
4)Liver dysfunction of Child-Pugh C
5)Requiring hemodialysis, or serum creatinine level is greater or equal 2.0mg/dL
6)Severe bleeding tendency
7)Poor nutrition (Lymphocyte count is less than 1200, Albumin level is less or equal 2.7g/dL or Pre-albumin level is less or equal 10mg/dL)
8)Acute inflammation
9)Direct invasion of stomach or bowel
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Goro Honda |
Organization
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Division name
Hepato-Biliary-Pancreatic Surgery
Zip code
Address
3-18-22 Honkomagome, Bunkyo-ku, Tokyo
TEL
03-3823-2101
ghon@cick.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Goro Honda |
Organization
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Division name
Hepato-Biliary-Pancreatic Surgery
Zip code
Address
3-18-22 Honkomagome, Bunkyo-ku, Tokyo
TEL
03-3823-2101
Homepage URL
ghon@cick.jp
Sponsor or person
Institute
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Institute
Department
Personal name
Funding Source
Organization
Japanese foundation for Multidisciplinary Treatment of Cancer
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
Pancreas Research Foundation of Japan
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
| 2008 | Year | 11 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2008 | Year | 07 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2012 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2013 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 11 | Month | 06 | Day |
Last modified on
| 2014 | Year | 05 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001796
| Research Plan | |
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