UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026939 |
|---|---|
| Receipt number | R000030898 |
| Scientific Title | A Phase II Clinical Trial of Carbon-ion Radiotherapy Combined with Gemcitabine for Locally Advanced Pancreatic Cancer |
| Date of disclosure of the study information | 2017/04/12 |
| Last modified on | 2024/01/05 15:26:10 |
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Basic information
Public title
A Phase II Clinical Trial of Carbon-ion Radiotherapy Combined with Gemcitabine for Locally Advanced Pancreatic Cancer
Acronym
Carbon-ion Radiotherapy wih Gemcitabine for Pancreatic Cancer (iROCK1605PA)
Scientific Title
A Phase II Clinical Trial of Carbon-ion Radiotherapy Combined with Gemcitabine for Locally Advanced Pancreatic Cancer
Scientific Title:Acronym
Carbon-ion Radiotherapy wih Gemcitabine for Pancreatic Cancer (iROCK1605PA)
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 the efficacy and safety of carbon-ion radiotherapy for locally advanced pancreatic cancer in Kanagawa Cancer Center
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Three-year overall survival
Key secondary outcomes
1) Local control period
2) Progression free period
3) Incidence of adverse events
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Carbon-ion radiotherapy with a total of 55.2Gy(RBE), consisting of 12 fractions for 4.6Gy(RBE) each
Chemotherapy with gemcitabine (1000mg/m2/week) for 3 weeks
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) Diagnosed as invasive pancreatic ductal adenocarcinoma by cytology (*1) or histopathology
*1: Class IV or V for cytology
2) No metastasis found by imaging studies: N0-1M0
3) Invasion into celiac trunk or superior mesenteric artery observed in abdominal CT or MRI: T4(UICC)
4) 20 years old or older and 80 years old or less of age at trial registration
5) 0 to 2 of Performance Status(ECOG)
6) No prior treatment of surgical resection (*2), chemotherapy or radiotherapy for pancreatic cancer
*2: Except for single laparotomy, gastrojejunostomy and choledochojejunostomy
7) Patients fulfilled all the following criteria of clinical laboratory. The clinical laboratory test should be performed within 7 day before registration.
(a) 3500/mm3 or more of white blood cell count
(b) 9.0g/dl or more of hemoglobin concentration
(c) 100000/mm3 or more of platelet count
(d) 3.0g/dL or more of albumin
(e) Total bilirubin
*2 mg/dl or more if subjects underwent no biliary drainage
*3 mg/dl or more if subjects underwent biliary drainage
(f) GOT (AST)
*100 IU or more if subjects underwent no biliary drainage
*150 IU or more if subjects underwent biliary drainage
(g) 1.2mg/dL or less of serum creatinine
8) No eligibility for other clinical studies on the Advanced Medical Care B(Senshin-Iryo B)
9) Obtained written informed consent
Key exclusion criteria
1) Finding of direct invasion in gastrointestinal duct as followings:
(a) Obvious finding of invasion in the stomach or duodenum in gastrointestinal endoscopy
(b) Invasive lesion protruding inside of gastrointestine in imaging studies such as computed tomography (CT)
2) Ascites found by the abdominal-pelvic CT
3) Gastric or duodenal ulcer except for ulcer scar
4) Patient with metallic stent for occlusive jaundice
5) Open wound or active and intractable infection in the target lesion of irradiation
6) Severe complications such as severe stroke, diabetes, heart disease, angina, myocardial infarction developed within 3 months, severe liver dysfunction and psychologic disease
7) Active double cancer including concurrent or metachronous tumor within two years, except for lesion equivalent to carcinoma in situ or intramucosal cancer which is completely treated by local therapeutic procedure.
8) Previous history of radiotherapy for targeted lesion
9) Conditions that attending physicians consider unsuitable for this clinical study due to medical or psychological issues
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Katoh |
Organization
Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization
Division name
Department of Carbon-ion Radiotherapy
Zip code
241-8515
Address
2-3-2 Nakao, Asahi-ku, Yokohama, Kanagawa Prefecture, JAPAN
TEL
045-520-2222
hkatoh@kcch.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Katoh |
Organization
Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization
Division name
Ion-beam Radiation Oncology Center
Zip code
241-8515
Address
2-3-2 Nakao, Asahi-ku, Yokohama, Kanagawa Prefecture, JAPAN
TEL
045-520-2222
Homepage URL
hkatoh@kcch.jp
Sponsor or person
Institute
Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization
Institute
Department
Personal name
Funding Source
Organization
Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
N/A
Name of secondary funder(s)
N/A
IRB Contact (For public release)
Organization
Kanagawa Cancer Center IRB
Address
2-3-2 Nakao, Asahi-ku, Yokohama, Kanagawa Prefecture
Tel
045-520-2222
clinical_trials@kcch.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
地方独立行政法人神奈川県立病院機構 神奈川県立がんセンター
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 04 | 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
Terminated
Date of protocol fixation
| 2017 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 30 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 12 | Day |
Last follow-up date
| 2020 | Year | 02 | Month | 07 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This clinical trial was terminated for reasons of the facility.
Management information
Registered date
| 2017 | Year | 04 | Month | 11 | Day |
Last modified on
| 2024 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030898
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
