UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006332 |
|---|---|
| Receipt number | R000007484 |
| Scientific Title | Phase II study of induction chemotherapy with gemcitabine and S-1 followed by chemoradiotherapy with S-1 in patients with locally advanced pancreatic cancer |
| Date of disclosure of the study information | 2011/09/12 |
| Last modified on | 2016/04/12 19:51:11 |
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Basic information
Public title
Phase II study of induction chemotherapy with gemcitabine and S-1 followed by chemoradiotherapy with S-1 in patients with locally advanced pancreatic cancer
Acronym
Phase II study of induction chemotherapy with gemcitabine and S-1 followed by chemoradiotherapy with S-1 in patients with locally advanced pancreatic cancer
Scientific Title
Phase II study of induction chemotherapy with gemcitabine and S-1 followed by chemoradiotherapy with S-1 in patients with locally advanced pancreatic cancer
Scientific Title:Acronym
Phase II study of induction chemotherapy with gemcitabine and S-1 followed by chemoradiotherapy with S-1 in patients with locally advanced pancreatic cancer
Region
| Japan |
Condition
Condition
locally advanced pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This phase II study was designed to assess the efficacy and safety of induction chemotherapy with gemcitabine and S-1 followed by chemoradiotherapy with S-1 in patients with locally advanced pancreatic cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1-year survival rate
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
Induction GS:
S-1 60/80/100 mg/day based on BSA, from the evening of day 1 to the morning of day 15, q3w, GEM 1000 mg/m2, day8 and 15
S-1+RT:
S-1 80/100/120 mg/day based on BSA, day1-14 and 22-35
RT 1.8Gy/day, 28fractions, total 50.4Gy
Maintenance chemotherapy with S-1:
S-1 80/100/120 mg/day based on BSA, day1-14, q3w
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1)Histologically or cytologically proven adenocarcinoma
(2)unresectable locally advanced pancreatic cancer without distant metastases
(3)no evidence of gastroduodenal invasion or obstruction
(4)ECOG PS 0 or 1
(5)No prior chemotherapy or radiotherapy
(6)Written informed consent
(7)Adequate organ function
Key exclusion criteria
(1)severe concurrent disease
(2)interstitial pneumonia, severe pulmonary emphysema or active pnemonia
(3)mental disorder
(4)active concomitant malignancy
(5)moderate or severe diarrhea, hemorrhagic colitis or peptic ulcer
(6)severe drug hypersensitibity
(7)pregnant or lactating females
(8)regular use of phenytoin, warfarin or frucitocin
(9)Under treatment with systemic steroid
(10)fever of 38 degrees centigrade or higher, or infection requiring systemic treatment
(11)inappropriate for entry onto the study, as diagnosed by primary physician
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Taketo Yamaguchi |
Organization
Chiba Cancer Center
Division name
Gastroenterology
Zip code
Address
666-2, Nitona-cho, Chuo-ku, Chiba, Chiba pref, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Chiba Cancer Center
Division name
Gastroenterology
Zip code
Address
TEL
Homepage URL
kesudou-gi@umin.ac.jp
Sponsor or person
Institute
Chiba Cancer Center
Institute
Department
Personal name
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
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
| 2011 | Year | 09 | Month | 12 | 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
| 2011 | Year | 08 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 09 | Month | 28 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 09 | Month | 12 | Day |
Last modified on
| 2016 | Year | 04 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007484
