UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008614 |
|---|---|
| Receipt number | R000010049 |
| Scientific Title | Phase II study of preoperative intensity modulated radiotherapy with gemcitabine and S-1 in patients with locally advanced pancreas cancer |
| Date of disclosure of the study information | 2012/08/04 |
| Last modified on | 2017/08/09 15:46:31 |
* 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
Phase II study of preoperative intensity modulated radiotherapy with gemcitabine and S-1 in patients with locally advanced pancreas cancer
Acronym
Preoperative IMRT with gemcitabine and S-1 in patients with pancreas cancer
Scientific Title
Phase II study of preoperative intensity modulated radiotherapy with gemcitabine and S-1 in patients with locally advanced pancreas cancer
Scientific Title:Acronym
Preoperative IMRT with gemcitabine and S-1 in patients with pancreas cancer
Region
| Japan |
Condition
Condition
Pancreas cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery | Radiology |
| Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Improvement of overall survival
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall survival
Key secondary outcomes
Resection rate
Tumor response rate
Local recurrence rate
Progression free survival
Adverse event rate
QOL
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Other |
Interventions/Control_1
Gemcitabine, S-1, Intensity modulated radiation therapy
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) Pathologically or cytlogically proven diagnosis of pancreas cancer.
2) A CT or A MRI with contrast of the thorax, abdomen and pelvis exclude distance metastases and peritoneum dissemination.
3) Zubroad performance status is 0-2.
4) Patients have not prior radiotherapy to upper abdomen.
5) Patients must provide clinical condition and have the ability to comprehend and informed consent prior to study entry.
Key exclusion criteria
1) Patients have four months or less life expectancy.
2) Patients have severe co-morbidities disease.
3) Woman of child bearing potential, expectant or nursing woman.
4) Patients have a history of severe drug allergy.
5) Patients have synchronous active cancer.
6) Patients had distant metastases after induction chemotherapy.
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akihiko Tsuchida |
Organization
Tokyo Medical University
Division name
3rd department of surgery
Zip code
Address
6-7-1 Nish-Shinjyuku Shinjyuku Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuichi Nakakawa |
Organization
Tokyo Medical University
Division name
3rd department of surgery
Zip code
Address
TEL
Homepage URL
naga@tokyo-med.ac.jp
Sponsor or person
Institute
3rd department of surgery
Tokyo Medical University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical University
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
| 2012 | Year | 08 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pubmed/28378027
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
| 2012 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | Month | 30 | 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
| 2012 | Year | 08 | Month | 04 | Day |
Last modified on
| 2017 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010049
