UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008888 |
|---|---|
| Receipt number | R000010419 |
| Scientific Title | Neoadjuvant radiation therapy concurrent with S-1 followed by systemic S-1/Gemcitabine therapy for Borderline resectable pancreatic cancer patients; A pilot study |
| Date of disclosure of the study information | 2012/09/14 |
| Last modified on | 2013/08/15 10:35:57 |
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Basic information
Public title
Neoadjuvant radiation therapy concurrent with S-1 followed by systemic S-1/Gemcitabine therapy for Borderline resectable pancreatic cancer patients; A pilot study
Acronym
The pilot study of neoadjuvant S1+RT followed by systemic GS therapy for Borderline resectable pancreatic cancer patients
Scientific Title
Neoadjuvant radiation therapy concurrent with S-1 followed by systemic S-1/Gemcitabine therapy for Borderline resectable pancreatic cancer patients; A pilot study
Scientific Title:Acronym
The pilot study of neoadjuvant S1+RT followed by systemic GS therapy for Borderline resectable pancreatic cancer patients
Region
| Japan |
Condition
Condition
pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
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 GS therapy for borderline resectable pancreatic cancer patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
completion rate
Key secondary outcomes
R0 resection rate , pathological response rate , survival rate, Response rate, adverse effect
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.
S-1+gemcitabine:
Gemcitabine(1000mg/m2) is given by intravenous infusion over 30 min on days 1, 8. S-1(80mg/m2) is given orally for 14 days followed by 1-week rest. This cycle was repeated 6 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 or diagnostic imaging proven diagnosis of pancreatic cancer
2) Definition of a Borderline respectable pancreatic cancer is filled in NCCN guidelines 2012 pancreatic adenocarcinoma
3) Patients of age =>20 and 75=>
4) Performance Status: 0-1(ECOG)
5) Patients who have not undergone chemotherapy and/or radiotherapy
6) All pancreas lesions and lymphnode metastases are included in the radiation field, 10 x 10 cm
7) Adequate oral intake
8) Biliary drainage was applied adequately in patients with obstructive jaundice
9) Without obvious direct invasion to digestive tract
10) Sufficient organ functions 14 days before registration
11) Written informed consent
Key exclusion criteria
1) Patients who have previously administered S-1 or gemcitabine
2) Patients who have previous history of radiotherapy to the abdomen
3) Uncontrollable watery or chornic diarrhea
4) Regular use of frucitocin, fenitoin or warfarin
5) Patients who can' t receive neither iodic drug because of drug allergy
6) Lung fibrosis or interstitial pneumonia which accompanied by clinical symptoms or are evident in imaging findings
7) Massive pleural or abdominal effusion
8) Those with Active infectious diseases
9) Uncontrolled diabetes
10) Simultaneous or metachronous (within 3 years) double cancers
11) Hemorrhagic peptic ulcer
12) Severe complications
13) Patients requiring systemic steroids medication
14) Severe mental disorders
15) Severe drug hypersensitivity
16) Pregnant or lactating women, or women with known or suspected pregnancy and men who want let to pregnancy
17) Patients seems inadequate for this study by investigators
18) Treatment history of a collagen disease or undergoing medical treatment
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasutoshi Kimura |
Organization
Sapporo Medical University Hospital
Division name
Department of Surgical Oncology and Gastroenterological Surgery
Zip code
Address
S1 W16, Chuoku, Sapporo city, Hokkaido, Japan
TEL
011-611-2111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Sapporo Medical University Hospital
Division name
Department of Surgical Oncology and Gastroenterological Surgery
Zip code
Address
TEL
Homepage URL
kimuray@sapmed.ac.jp
Sponsor or person
Institute
Department of Surgical Oncology and Gastroenterological Surgery, Sapporo Medical University Hospital
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
| 2012 | Year | 09 | Month | 14 | 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
Terminated
Date of protocol fixation
| 2012 | Year | 09 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 09 | Month | 10 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 09 | Month | 10 | Day |
Last modified on
| 2013 | Year | 08 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010419
