UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012296 |
|---|---|
| Receipt number | R000014379 |
| Scientific Title | Phase II trial of carbon-ion radiotherapy with Gemcitabine for locally advanced pancreatic cancer (GUNMA1301) |
| Date of disclosure of the study information | 2013/11/14 |
| Last modified on | 2019/11/20 08:26:35 |
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Basic information
Public title
Phase II trial of carbon-ion radiotherapy with Gemcitabine for locally advanced pancreatic cancer (GUNMA1301)
Acronym
Carbon-ion radiotherapy with Gemcitabine for locally advanced pancreatic cancer (GUNMA1301)
Scientific Title
Phase II trial of carbon-ion radiotherapy with Gemcitabine for locally advanced pancreatic cancer (GUNMA1301)
Scientific Title:Acronym
Carbon-ion radiotherapy with Gemcitabine for locally advanced pancreatic cancer (GUNMA1301)
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
To evaluate safety and efficacy of carbon-ion radiotherapy with Gemcitabine for locally advanced pancreatic cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
overall survival rate
Key secondary outcomes
Response rate
Local control rate at two year
Progression free survival rate
Acute and late toxicity
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 | Other |
Interventions/Control_1
Carbon-ion radiation therapy
Chemotherapy (Gemcitabine)
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) Pathologically diagnosed pancreatic invasive ductal carcinoma.
2) Locally advanced (unresectable) disease.
3) No distant metastasis except for paraaortic lymphnode.
4) No invasion to mocosal membrane of stomach or intestine.
5) Measureable tumor
6) PS0-2
7) good function of other organs
8) Informed consent
Key exclusion criteria
1) Past history of irradiation to the target region
2) Infection around the target
3) Metalic stent at the bile duct
4) Pleural effusions or ascites
5) Past history of chemotherapy within 4 weeks before start of this treatment
6) Uncontrolled severe complication
7) Active ulcer of stomach or duodenum
8) Active double cancers
9) Interstitial pneumonia
10) In pregnancy or during the lactation preiod
11) Other medical or psychological unsuitable reasons
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Nakano |
Organization
Gunma University
Division name
Gunma University Heavy Ion Medical Center
Zip code
371-8511
Address
3-39-22 Showa, Maebashi, Gunma
TEL
027-220-8378
tnakano@med.gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Tatsuya |
| Middle name | |
| Last name | Ohno |
Organization
Gunma University
Division name
Gunma University Heavy Ion Medical Center
Zip code
371-8511
Address
3-39-22 Showa, Maebashi, Gunma
TEL
027-220-8378
Homepage URL
tohno@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University Heavy Ion Medical Center
Institute
Department
Personal name
Funding Source
Organization
MEXT
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gunma Univ. IRB
Address
3-39-15 Showa machi, Maebashi, Gunma
Tel
027-220-8740
mkunimine@gunma-u.ac.jp
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
| 2013 | Year | 11 | Month | 14 | Day |
Related information
URL releasing protocol
NIA
Publication of results
Unpublished
Result
URL related to results and publications
NIA
Number of participants that the trial has enrolled
21
Results
MST=16.5M
Overall survival 1y 69%, 2y 23%
Local control 1y 93%, 2y 72%
In favorable group (CA19-9 <1000, D95>52.8G),
Overall survival 1y 84%, 2y 47%
Local control 1y 100%, 2y 76%
MST 22.2M
Results date posted
| 2019 | Year | 11 | Month | 20 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
age: 69.5 (39-80)
tumor volume 23.4 (1.7-130)cc
CA19-9 114( 1-3675)
Participant flow
median follow up 14.6M
Adverse events
Gastric ulcer grade 3 2cases
Cholangitis grade3 2cases
Outcome measures
Overall survival
Local control rate
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 06 | Month | 10 | Day |
Date of IRB
| 2013 | Year | 06 | Month | 30 | Day |
Anticipated trial start date
| 2013 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 11 | 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
| 2013 | Year | 11 | Month | 14 | Day |
Last modified on
| 2019 | Year | 11 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014379
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