UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012293 |
|---|---|
| Receipt number | R000014362 |
| Scientific Title | Neoadjuvant radiation therapy concurrent with S-1 followed by systemic Gemcitabine therapy for Borderline resectable pancreatic cancer patients; A phase2 study |
| Date of disclosure of the study information | 2013/11/15 |
| Last modified on | 2017/08/07 08:50:43 |
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Basic information
Public title
Neoadjuvant radiation therapy concurrent with S-1 followed by systemic Gemcitabine therapy for Borderline resectable pancreatic cancer patients; A phase2 study
Acronym
A phase2 study of neoadjuvant S1+RT followed by systemic Gem therapy for Borderline resectable pancreatic cancer patients
Scientific Title
Neoadjuvant radiation therapy concurrent with S-1 followed by systemic Gemcitabine therapy for Borderline resectable pancreatic cancer patients; A phase2 study
Scientific Title:Acronym
A phase2 study of neoadjuvant S1+RT followed by systemic Gem therapy for Borderline resectable pancreatic cancer patients
Region
| Japan |
Condition
Condition
pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hematology and clinical oncology | Hepato-biliary-pancreatic surgery |
| Radiology | Operative medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To verify the safety, the efficacy and the feasibility of neoadjuvant radiation concurrent with S-1 followed by systemic Gemcitabine therapy for borderline resectable pancreatic cancer patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
R0 resection rate
Key secondary outcomes
completion rate, pathological effect , Response rate, CA19-9 response rate, progression free survival, distant metastasis free survival, overall survival, adverse effect, surgical complication
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
Concurrent radiotherapy with S-1: S-1 (80mg/m2) on the irradiated day, Radiotherapy; a total dose of 50.4 Gy in 28 fractions.
Systemic Gemcitabine therapy: Gemcitabine (1000mg/m2) is given by intravenous infusion over 30 min on days 1, 8, 15 every 4 week. This cycle was repeated 3 cycles.
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Pathologically or cytologically proven diagnosis of pancreas cancer.
2) Definition of a Borderline resectable pancreatic cancer is filled in NCCN guidelines 2012 pancreatic adenocarcinoma
3) No hepatic metastasis by EOB-MR
4) Patients of age =>20 and 75>
5) Performance Status:0-1 (ECOG)
6) Adequate oral intake
7) Good main organ function
8) Written informed consent
Key exclusion criteria
1) treatment history of a pancreatic cancer (chemotherapy, radiotherapy, surgical)
2) treatment history of other malignant tumors (chemotherapy, radiotherapy)
3) Patients who can' t receive neither iodic drug because of drug allergy
4) Including in an exposure field is impossible with contrast enhanced CT
5) Massive pleural or abdominal effusion
6) Pleural membranes and peritoneum sowing are proved by cytological diagnosis
7) Existence of tumor exposure with CT or Endoscope
8) Hemorrhagic peptic ulcer
9) Watery diarrhea
10) Regular use of frucitocin, fenitoin or warfarin
11) Lung fibrosis or intestinal pneumonia, and anamnesis or imaging findings
12) Severe infection
13) Serious complications (e.g. heart failure, hepatic failure, intestinal paralysis, intestinal obstruction)
14) Uncontrolled diabetes
15) Simultaneous or metachronous (within 3 years) double cancers
16) Patients requiring systemic steroids medication
17) Severe mental illness
18) Severe drug hypersensitivity
19) Males that are currently attempting to produce a pregnancy
20) Pregnant females, possibly pregnant females, females wishing to become pregnant
21) Patients seems inadequate for this study by investigators
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tsuyoshi Hayashi |
Organization
Sapporo Medical University
Division name
Department of Medical Oncology and Hematology
Zip code
Address
S1, W16, Chuoku, Sapporo, Hokkaido, Japan
TEL
011-611-2111
thayashi69@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tsuyoshi Hayashi |
Organization
Sapporo Medical University
Division name
Department of Medical Oncology and Hematology
Zip code
Address
S1, W16, Chuoku, Sapporo, Hokkaido, Japan
TEL
011-611-2111
Homepage URL
thayashi69@sapmed.ac.jp
Sponsor or person
Institute
Hokkaido Pancreatic Cancer Study Group (HOPS)
Institute
Department
Personal name
Funding Source
Organization
none
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
Address
Tel
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
| 2013 | Year | 11 | Month | 15 | 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
Completed
Date of protocol fixation
| 2013 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 11 | Month | 15 | Day |
Last follow-up date
| 2017 | Year | 04 | Month | 28 | Day |
Date of closure to data entry
| 2017 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 11 | Month | 14 | Day |
Last modified on
| 2017 | Year | 08 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014362
