UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017521 |
|---|---|
| Receipt number | R000020308 |
| Scientific Title | Phase II study of dynamic tumor tracking intensity-modulated radiotherapy in patients with locally advanced pancreatic cancer |
| Date of disclosure of the study information | 2015/07/01 |
| Last modified on | 2020/11/14 18:56:33 |
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Basic information
Public title
Phase II study of dynamic tumor tracking intensity-modulated radiotherapy in patients with locally advanced pancreatic cancer
Acronym
Phase II study of dynamic tumor tracking IMRT for locally advanced pancreatic cancer
Scientific Title
Phase II study of dynamic tumor tracking intensity-modulated radiotherapy in patients with locally advanced pancreatic cancer
Scientific Title:Acronym
Phase II study of dynamic tumor tracking IMRT for locally advanced pancreatic cancer
Region
| Japan |
Condition
Condition
Pancreatic cancer
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of dynamic tumor tracking intensity-modulated radiotherapy in patients with locally advanced pancreatic cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
1-year freedom from loco-regional progression
Key secondary outcomes
Loco-regional progression-free survival, overall survival, progression-free survival, the incidence of acute adverse events, the incidence of late adverse events, treatment-related morbidity/early mortality , the accuracy in dynamic tumor tracking technique
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 |
Interventions/Control_1
Intensity-modulated radiotherapy(IMRT)
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) Pancreatic cancer pathologically proven with pancreatic juice or biops. 2) Clinical stage IIA, IIB, III (UICC) 3) ECOG PS;0-1
4) Without previous surgical resection for pancreatic cancer or irradiation to upper abdomen
5) adequate oral intake
6) Adequate organ functions;
white blood cells >= 3,000/m3
Neutrophil>=2000/m3
platelets >= 100,000/m3
hemoglobin >= 9.0g/dl
AST<= 150 U/L
ALT<= 150 U/L
total bilirubin <= 2.0mg/dL
Creatinine <= 1.2mg/dL
Albumin >= 3.0 mg/dL
Without fever over 38 degree
7) diagnosed as capable of dynamic tumor tracking with inserted fiducial marker 8) Written Informed Consent
Key exclusion criteria
1) Intersitial pneumonia or pulmonary fibrosis
2) previous irradiation to upper abdomen
3) Severe comorbidity
4) Pleural effusion or Ascites
5) Tumor invasion to stomach, duodenum or intestine
6) Patients with double cancer (double cancer or treated cancer with no more than 3-year disease-free period). However, carcinoma in situ or intra-mucosal cancer-equivalent lesion are not to be included in double cancer
7) Severe allergy history to gold
8) Unstable and Uncontrollable diabetic mellitus, or severe collagen disease
9) Woman during pregnancy or breast-feeding, patient who wish pregnancy
10) Psychiatric disease
11) Inappropriate patients for this study judged by physicians
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Mizowaki |
Organization
Kyoto University Hospital
Division name
Department of Radiation Oncology
Zip code
6068507
Address
54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto, Japan
TEL
075-751-3417
mizo@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Yukinori |
| Middle name | |
| Last name | Matsuo |
Organization
Kyoto University Hospital
Division name
Department of Radiation Oncology and Image-Applied Therapy
Zip code
6068507
Address
54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto, Japan
TEL
075-751-3417
Homepage URL
ymatsuo@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
AMED
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
54 Shogoin-Kawaharacho, Sakyo-ku, Kyoto
Tel
075-753-4680
ethcom@kuhp.kyoto-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
| 2015 | Year | 07 | Month | 01 | 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
Main results already published
Date of protocol fixation
| 2015 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 06 | Month | 24 | Day |
Anticipated trial start date
| 2015 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 11 | Month | 24 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 05 | Month | 12 | Day |
Last modified on
| 2020 | Year | 11 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020308
| Research Plan | |
|---|---|
| Registered date | File name |
| 2020/03/05 | YC1057+膵臓追尾IMRTプロトコール20190613.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
| 2020/03/05 | 2020 AMED-DTT-IMRT-PK0301 upload.xlsx |
