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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012293
Receipt No. 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

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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
Email 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
Email thayashi69@sapmed.ac.jp

Sponsor
Institute Hokkaido Pancreatic Cancer Study Group (HOPS)
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014362

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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