UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053195 |
|---|---|
| Receipt number | R000060713 |
| Scientific Title | A phase II clinical trial of neoadjuvant gemcitabine and S-1 with concurrent radiotherapy in patients with resectable and borderline resectable pancreatic ductal adenocarcinoma |
| Date of disclosure of the study information | 2023/12/22 |
| Last modified on | 2023/12/22 13:03:03 |
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Basic information
Public title
A phase II clinical trial of neoadjuvant gemcitabine and S-1 with concurrent radiotherapy in patients with resectable and borderline resectable pancreatic ductal adenocarcinoma
Acronym
A phase II clinical trial of neoadjuvant gemcitabine and S-1 with concurrent radiotherapy in patients with resectable and borderline resectable pancreatic ductal adenocarcinoma
Scientific Title
A phase II clinical trial of neoadjuvant gemcitabine and S-1 with concurrent radiotherapy in patients with resectable and borderline resectable pancreatic ductal adenocarcinoma
Scientific Title:Acronym
A phase II clinical trial of neoadjuvant gemcitabine and S-1 with concurrent radiotherapy in patients with resectable and borderline resectable pancreatic ductal adenocarcinoma
Region
| Japan |
Condition
Condition
resectable and borderline resectable (BR-PV) pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of preoperative chemoradiotherapy with gemcitabine and S-1 for resectable pancreatic cancer and borderline resectable pancreatic ductal adenocarcinoma
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Pathological tumor response to neoadjuvant chemoradiotherapy
Key secondary outcomes
Completion and adverse event rate, pathological tumor response, histological curative resection (R0 ratio), morbidity rate, recurrence free survival, overall survival
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
To investigate the pathological tumor response of cases that underwent neoadjuvant chemoradiation treatment using gemcitabine(800mg/m2) and S1(60mg/m2) combined with radiotherapy(50Gy/25fr) followed by curative pancreatic resection for resectable and borderline resectable (BR-PV) pancreatic ductal adenocarcinoma
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
| 86 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patients with radiologically defined patentially resectable or borderline resectable (BR-PV) pancreatic ductal adenocarcinoma
2) Patients who have not undergone radiotherapy to the abdomen
3) Patients who have not undergone chemotherapy within 6 months
4) Patients with Performance status of 0/1
5) Patients with sustained organ function
6) Patients who received informed consent
Key exclusion criteria
1) Patients with pulmonary fibrosis or interstitial pneumonia
2) Patients with other active cancers
3) Patients who can not take medicine orally
4) Patients with severe allergies
5) Patients with watery diarrhea
6) Patients with severe co-morbid disease
7) Patients seems inadequate for this study by investigator(s)
Target sample size
64
Research contact person
Name of lead principal investigator
| 1st name | Keiichi |
| Middle name | |
| Last name | Okano |
Organization
Faculty of Medicine, Kagawa University
Division name
Department of Gastroenterological Surgery
Zip code
761-0793
Address
1750-1, Ikenobe, Miki-cho, Kita-gun, Kagawa, Japan
TEL
087-898-5111
okano.keiichi@kagawa-u.ac.jp
Public contact
Name of contact person
| 1st name | Hironobu |
| Middle name | |
| Last name | Suto |
Organization
Faculty of Medicine, Kagawa University
Division name
Department of Gastroenterological Surgery
Zip code
761-0793
Address
1750-1, Ikenobe, Miki-cho, Kita-gun, Kagawa, Japan
TEL
087-898-5111
Homepage URL
suto.hironobu@kagawa-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterological Surgery, Faculty of Medicine, Kagawa University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Faculty of Medicine, Kagawa University
Address
1750-1, Ikenobe, Miki-cho, Kita-gun, Kagawa, Japan
Tel
087-898-5111
kenkyushien@kagawa-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
| 2023 | Year | 12 | Month | 22 | 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
| 2023 | Year | 02 | Month | 27 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 27 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2029 | 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
| 2023 | Year | 12 | Month | 22 | Day |
Last modified on
| 2023 | Year | 12 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060713
