UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000012296
Receipt No. 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 (Ver. 7)

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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
Email 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
Email tohno@gunma-u.ac.jp

Sponsor
Institute Gunma University Heavy Ion Medical Center
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014379