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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030762
Receipt No. R000035115
Scientific Title A Phase II Clinical Trial of Carbon-ion Radiotherapy for Locally Advanced Pancreatic Cancer
Date of disclosure of the study information 2018/01/12
Last modified on 2018/04/13

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Basic information
Public title A Phase II Clinical Trial of Carbon-ion Radiotherapy for Locally Advanced Pancreatic Cancer
Acronym Carbon-ion radiotherapy for pancreatic cancer (iROCK-1702PA)
Scientific Title A Phase II Clinical Trial of Carbon-ion Radiotherapy for Locally Advanced Pancreatic Cancer
Scientific Title:Acronym Carbon-ion radiotherapy for pancreatic cancer (iROCK-1702PA)
Region
Japan

Condition
Condition Locally Advanced Pancreatic Cancer
Classification by specialty
Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of carbon-ion radiotherapy for the patients with 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 Proportion of patients who developed grade 2 or severe adverse events in the upper gastrointestinal tract within a year after irradiation (3 years of observation period)
Key secondary outcomes 1) Overall survival
2) Local control survival
3) Progression free survival
4) Adverse event rate

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;
4.6Gy(RBE) per day, A total of 55.2Gy(RBE) / 12 Fr
Chemotherapy;
Three consecutive administration of Gemcitabine (1000mg/m2) once a week and no administration in the fourth week
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) Patient who is diagnosed as invasive pancreatic ductal adenocarcinoma by cytological* or histopathological biopsy, OR, those who clinically diagnosed as primary malignant tumor in the pancreas, except for lymphoma
* Eligible for class IV or V
2) Patient who shows no distant metastasis by imaging studies (N0-1M0)
3) Patient who fulfills either following conditions;
- Locally advanced pancreatic cancer with non-curative resection
- Locally advanced pancreatic cancer with curative resection, but inoperative case due to complications
- Patients with locally advanced pancreatic cancer who deny the resection
4) 20 years old or more at trial registration
5) 0 to 2 of Performance Status (ECOG)
6) Patient who fulfills all the following conditions if he/she undergoes concomitant chemotherapy
All the laboratory data are measured within 7 days before trial registration.
(a) White blood cells >= 3500 /mm3
(b) Hemoglobin >= 9.0 g/dl
(c) Platelet >= 100000 /mm3
(d) Albumin >= 3.0 g/dl
(e) Total bilirubin
Patient with the history of drainage procedure: =< 2 mg/dl
Patient without the history of drainage procedure: =< 3 mg/dl
(f) GOT(AST)
Patient with the history of drainage procedure: =< 100 IU
Patient without the history of drainage procedure: =< 150 IU
(g) Serum creatinine =< 1.2 mg/dl
*These conditions are NOT required for Patient without concomitant chemotherapy.
7) Patient who is ineligible for other clinical trials including Advanced Medicine Program B (Sen-shin Iryo B)
8) Written consent obtained for the participation in this study
Key exclusion criteria 1) Patient with direct invasion in the gastrointestinal tract which fulfills either following conditions;
(a) Endoscopic findings of obvious invasion in stomach and duodenum
(b) Imaging findings, including those by computed tomography, of invasion inside the gastrointestinal tract
2) Obvious peritoneal dissemination, except for small amount of ascites or negative cytology of ascites
3) Gastric or duodenal ulcer, except for ulcer scar
4) Metallic stent for occlusive jaundice
5) Open injury or active and intractable infection in the target lesion
6) Severe complications such as severe cerebrovascular disease, intractable diabetes, severe cardiovascular disease, angina, myocardial infarction within 3 months from the onset, severe liver dysfunction, severe psychiatric disease if concomitant radiochemotherapy is selected, Severe complication which influences irradiation of carbon-ion beam such as psychiatric disease if carbon-ion radiotherapy alone is selected
7) Active and untreated double cancer, except for intraepithelial carcinoma, intramucinous carcinoma or malignancy controlled for a long-term
8) Medically or psychologically unsuitable conditions
Target sample size 77

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Dr. Hiroyuki Katoh
Organization Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization
Division name Department of Carbon-ion Radiotherapy
Zip code
Address 2-3-2 Nakao, Asahi-ku, Yokohama, Kanagawa Prefecture, JAPAN
TEL 045-520-2222
Email hkatoh@kcch.jp

Public contact
Name of contact person
1st name
Middle name
Last name Dr. Hiroyuki Katoh
Organization Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization
Division name Ion-beam Radiation Oncology Center
Zip code
Address 2-3-2 Nakao, Asahi-ku, Yokohama, Kanagawa Prefecture, JAPAN
TEL 045-520-2222
Homepage URL
Email hkatoh@kcch.jp

Sponsor
Institute Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization
Institute
Department

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
Address
Tel
Email

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
2018 Year 01 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 Open public recruiting
Date of protocol fixation
2017 Year 11 Month 27 Day
Date of IRB
Anticipated trial start date
2017 Year 12 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
2018 Year 01 Month 11 Day
Last modified on
2018 Year 04 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035115

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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