UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034410 |
|---|---|
| Receipt number | R000039240 |
| Scientific Title | A phase 2 study of induction chemotherapy followed by chemoradiotherapy for patients with borderline resectable pancreatic cancer |
| Date of disclosure of the study information | 2018/10/10 |
| Last modified on | 2019/04/10 17:20:10 |
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Basic information
Public title
A phase 2 study of induction chemotherapy followed by chemoradiotherapy for patients with borderline resectable pancreatic cancer
Acronym
A phase 2 study of induction chemotherapy followed by chemoradiotherapy for patients with borderline resectable pancreatic cancer
Scientific Title
A phase 2 study of induction chemotherapy followed by chemoradiotherapy for patients with borderline resectable pancreatic cancer
Scientific Title:Acronym
A phase 2 study of induction chemotherapy followed by chemoradiotherapy for patients with borderline resectable pancreatic cancer
Region
| Japan |
Condition
Condition
Pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate that the efficacy of the induction chemotherapy followed by chemoradiotherapy for borderline resectable pancreatic cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
R0 resection rate
Key secondary outcomes
Relapse-free survival
Overall survival
Treatment completion rate
Adverse effect
Pathological response
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
A total of three courses of nab-Paclitaxel and Gemcitabine followed by TS-1 with concurrent radiotherapy of 45Gy for 5 weeks
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Histologically proven or radiologically confirmed pancreatic cancer
2) No prior treatment for pancreatic cancer
3) Age between 20 to 85
4) ECOG performance status 0/1
5) White blood cell count above 3000/mm3
Neutrophil count above 1000/mm3
Platelet count above 100000/mm3
Hemoglobin above 8.0 g/dl
Total billirubin below 3.0 mg/dl
AST, ALT below 150 IU/L
Creatinine below 1.5 mg/dl
6) No exclusion criteria
7) Proper informed consent
Key exclusion criteria
1) Contraindication of nab-PTX, GEM, TS-1
2) Pleuritic effusion refractory to diuretics
3) Presence of distant metastasis
4) Presence of concurrent advanced cancer
5) Presence of clinically obvious infection
6) Prior radiotherapy to abdominal lesions
7) Previous history of myocardial infarction within three months
8) Severely mental retardation
9) Current status of pregnancy and lactation, or the possibility of these statuses.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Minoru |
| Middle name | |
| Last name | Kitago |
Organization
Keio University School of Medicine
Division name
Department of Surgery
Zip code
1608582
Address
Shinanomachi 35, Shinjuku, Tokyo
TEL
03-3353-1211
dragonpegasus@keio.jp
Public contact
Name of contact person
| 1st name | Minoru |
| Middle name | |
| Last name | Kitago |
Organization
Keio University School of Medicine
Division name
Department of Surgery
Zip code
1608582
Address
Shinanomachi 35 Shijuku Tokyo
TEL
0333531211
Homepage URL
dragonpegasus@keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Keio University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Surgery, Tochigi Medical Center
Department of Surgery, Ichikawa General Hospital, Tokyo Dental College
Department of Surgery, Tokyo Medical Center
Department of Surgery, Saitama National Hospital
Department of Surgery, Hiratsuka City Hospital
Department of Surgery, Fussa Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical committee, Keio University
Address
Shinanomachi 35, Shinjuku, Tokyo
Tel
03-3353-1211
med-rinri-jimu@adst.keio.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
独立行政法人 国立病院機構 栃木医療センター 外科 (栃木）
東京歯科大学市川総合病院 外科 （千葉）
独立行政法人国立病院機構東京医療センター 外科 （東京）
独立行政法人 国立病院機構 埼玉病院 外科 （埼玉）
平塚市民病院 外科 （神奈川）
公立福生病院 外科 （東京）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 10 | Month | 10 | 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
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 10 | Month | 09 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 25 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 25 | Day |
Last follow-up date
| 2023 | Year | 12 | 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
| 2018 | Year | 10 | Month | 09 | Day |
Last modified on
| 2019 | Year | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039240
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