UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042932 |
|---|---|
| Receipt number | R000046908 |
| Scientific Title | A phase I/II study of neoadjuvant chemoradiotherapy for pancreatic cancer. |
| Date of disclosure of the study information | 2021/01/31 |
| Last modified on | 2021/08/01 16:43:51 |
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Basic information
Public title
A phase I/II study of neoadjuvant chemoradiotherapy for pancreatic cancer.
Acronym
J-PACS 05
Scientific Title
A phase I/II study of neoadjuvant chemoradiotherapy for pancreatic cancer.
Scientific Title:Acronym
J-PACS 05
Region
| Japan |
Condition
Condition
Pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the safety and efficacy of GnP therapy combined with IMRT for locally advanced pancreatic cancer including BR pancreatic cancer and UR-LA pancreatic cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Phase I; Setting the optimal radiation dose
Phase II; Conversion ratio
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Gemcitabine + NabPTx: Gemcitabine 1000mg / m2 and NabPTx 125mg / m2 are intravenously infused on the same day, and the treatment is given once a week for 3 consecutive weeks, and the drug is withdrawn in the 4th week.
Intensity-modulated radiotherapy (IMRT): Start after the end of 2nd GnP administration and before the end of 1 course (Day 28). The irradiation dose is 1.8 Gy at a time, and it is administered 23 to 30 times.
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) Patients with pancreatic cancer confirmed by histology or cytology
2) Patients with locally advanced pancreatic cancer without distant metastases and considered difficult to resect curatively.
3) No prior treatment history (surgical excision, chemotherapy, radiation, etc.)
4) Age at registration is 20 years old or older and under 80 years old
5) Performance status (ECOG) is 0, 1
6) Expected to survive for 3 months or more from the start of treatment
7) The functions of major organs (bone marrow, liver, kidney, lung, etc.) are maintained.
8) Sufficient urine volume is secured (approximate: 1200 ml / day or more)
9) Cases that can be taken orally
10) Written consent of the person has been obtained
Key exclusion criteria
1) Exclude non-curative factors found during radical resection
2) Have overt pulmonary fibrosis or interstitial pneumonia
3) Concomitant with active infectious diseases (HB, HCV, HIV infection, etc.)
4) Have uncontrollable diabetes, heart failure, angina, arrhythmia and myocardial infarction within 6 months of onset
5) Have watery diarrhea
6) Cases using flucytosine and phenytoin
7) Pregnant, lactating and likely or willing to become pregnant
8) Have a serious drug allergy
9) Have active double cancer (not applicable to cases 5 years after complete cure)
10) Have other serious complications
11) Have severe neuropsychiatric symptoms, renal impairment, hearing impairment
12) Chickenpox patients
13) Previous treatment history (surgical excision, chemotherapy, radiation, etc.) for this disease
14) In addition, the doctor in charge judged that it was inappropriate to carry out this study safely.
Target sample size
58
Research contact person
Name of lead principal investigator
| 1st name | Tadashi |
| Middle name | |
| Last name | Uwagawa |
Organization
The Jikei University school of medicine
Division name
Department of Surgery
Zip code
105-8461
Address
3-25-8, Nishi-shinbashi, Minatoku, Tokyo
TEL
0334331111
uwatadashi@msn.com
Public contact
Name of contact person
| 1st name | Tadashi |
| Middle name | |
| Last name | Uwagawa |
Organization
The Jikei University school of medicine
Division name
Department of Surgery
Zip code
105-8461
Address
3-25-8, Nishi-shinbashi, Minatoku, Tokyo
TEL
0334331111
Homepage URL
uwatadashi@msn.com
Sponsor or person
Institute
The Jikei University school of medicine
Institute
Department
Personal name
Funding Source
Organization
The Jikei University school of medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Jikei University Certified Review Board
Address
3-25-8, Nishi-shinbashi, Minatoku, Tokyo
Tel
0334331111
crb@jikei.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
| 2021 | Year | 01 | Month | 31 | 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
| 2020 | Year | 10 | Month | 06 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 15 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 06 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 01 | Month | 06 | Day |
Last modified on
| 2021 | Year | 08 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046908
