UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030762 |
|---|---|
| Receipt number | 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 | 2023/12/27 11:27:40 |
* 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
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 | 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
| 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
30
Results
This study confirmed safety and efficacy comparable to those reported from prior facilities.
Results date posted
| 2023 | Year | 12 | Month | 27 | Day |
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
| 2017 | Year | 11 | Month | 27 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 28 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 28 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2026 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 01 | Month | 11 | Day |
Last modified on
| 2023 | Year | 12 | Month | 27 | Day |
Link to view the page
Value
https://center6.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 |
