UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000032642 |
|---|---|
| Receipt number | R000037222 |
| Scientific Title | Phase 2 study of S-1 and concurrent breath controlled intensity modulated radiation therapy for locally advanced unresectable pancreatic cancer. |
| Date of disclosure of the study information | 2018/05/21 |
| Last modified on | 2023/11/22 14:37:18 |
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Basic information
Public title
Phase 2 study of S-1 and concurrent breath controlled intensity modulated radiation therapy for locally advanced unresectable pancreatic cancer.
Acronym
Phase 2 study of S-1 and concurrent IMRT for locally advanced unresectable pancreatic cancer.
Scientific Title
Phase 2 study of S-1 and concurrent breath controlled intensity modulated radiation therapy for locally advanced unresectable pancreatic cancer.
Scientific Title:Acronym
Phase 2 study of S-1 and concurrent IMRT for locally advanced unresectable pancreatic cancer.
Region
| Japan |
Condition
Condition
Pancreatic duct adenocarcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hematology and clinical oncology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate efficacy and safety of S-1 and concurrent IMRT for locally advanced unresectable pancreatic cancer patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Response rate
Key secondary outcomes
Completion rate, CA19-9 response rate, Progression free survival, distant metastasis free survival, Overall survival, Rate of adverse event
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
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patients receive concurrent IMRT with S-1.
S-1; 80mg/m2 on the irradiated day
Radiotherapy; a total dose of 70 Gy in 28 fractions at gross tumor volume (GTV) and 50.4 Gy in 28 fractions at border of planning target volume (PTV)
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Histologically or cytologically proven adenocarcinoma and consistent with adenocarcinoma by diagnostic imaging.
2) Diagnosed with locally advanced unresectable by contrast enhancement CT or MRI and suitable for concurrent chemoradiotherapy.
3) Diagnosed with inoperable cancer by gastroenterologist or surgeon.
4) Without obvious organ metastases by EOB-MRI or contrast enhancement CT.
5) ECOG PS of 0, 1 or 2.
6) Preserved oral intake function.
7) Adequate organ function.
8) Written informed consent.
Key exclusion criteria
1) Previous history of radiotherapy for pancreatic cancer.
2) Moderate pleural effusion or ascites or cytologically proven pleural or abdominal dissemination.
3) Gastric or duodenal ulcer due to tumor invasion.
4) Active gastric or duodenal ulcer
5) Watery diarrhea
6) Patients requiring the administration of phenytoin, warfarin potassium or flucytosine.
7) Interstitial pneumonia or lung fibrosis.
8) Active infection.
9) Severe complication, such as heart disease, renal disease, and hepatic disease.
10) Patients requiring systemic steroids medication.
11) Psychosis.
12) Drug allergy.
13) Pregnant or lactating women of women of child bearing potential and men who want to get partner pregnant.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Masanori |
| Middle name | |
| Last name | Someya |
Organization
Sapporo Medical University, School of Mecidine
Division name
Department of Radiology
Zip code
060-8543
Address
S1W16, chuo-ku, Sapporo
TEL
+81-11-611-2111
someya@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | Masanori |
| Middle name | |
| Last name | Someya |
Organization
Sapporo Medical University, School of Mecidine
Division name
Department of Radiology
Zip code
060-8543
Address
S1W16, chuo-ku, Sapporo
TEL
+81-11-611-2111
Homepage URL
http://web.sapmed.ac.jp/hohsyasen/index.html
someya@sapmed.ac.jp
Sponsor or person
Institute
Department of Radiology, Sapporo Medical University, School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional review board
Address
S1W16, chuo-ku, Sapporo
Tel
+81-11-611-2111
ji-rskk@sapmed.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
札幌医科大学付属病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 05 | Month | 21 | 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
10
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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 03 | Month | 30 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 03 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 21 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
As of 5/22/2023, 11 participants are registered
Recruitment of participants ended as protocol treatment is no longer available due to updating of the radiotherapy machine.
Management information
Registered date
| 2018 | Year | 05 | Month | 19 | Day |
Last modified on
| 2023 | Year | 11 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037222
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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