UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000003795
Receipt number R000004517
Scientific Title Phase I study of preoperative chemo-radiotherapy with alternate-day administrations of S-1 and radiation in patients with pancreatic cancer
Date of disclosure of the study information 2010/06/22
Last modified on 2014/05/08 14:44:38

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Basic information

Public title

Phase I study of preoperative chemo-radiotherapy with alternate-day administrations of S-1 and radiation in patients with pancreatic cancer

Acronym

Phase I study of preoperative chemo-radiotherapy in patients with pancreatic cancer

Scientific Title

Phase I study of preoperative chemo-radiotherapy with alternate-day administrations of S-1 and radiation in patients with pancreatic cancer

Scientific Title:Acronym

Phase I study of preoperative chemo-radiotherapy in patients with pancreatic cancer

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 evaluate the efficacy and feasibilty for S1 and radiotherapy as neoadjuvant against pancreatic cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase I


Assessment

Primary outcomes

Safety,Efficacy

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Dose comparison

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

preoperative chemoradiotherapy with 1 course of S-1

Interventions/Control_2

preoperative chemoradiotherapy with 2course of S-1

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

80 years-old >=

Gender

Male and Female

Key inclusion criteria

1)Confirmed boarder-line resectable pancreatic cancer as adenocarcinoma by histological, cytological, or radiological examinations
2)Confirmed target region
3)No prior treatment
4)Age 20-80
5)PS 0/1
6)Adequate organ functions
neutrophils >=1,500/mm3
leukocytes >=4,000/mm3, =<12,000/mm3
platelets >=100,000/mm3
hemoglobin >=10.0g/dL
AST(GOT)/ALT(GPT)/ALP within 3 times of normal limits
total bilirubin <=1.5mg/dL
BUN <= 25mg/dl
serum creatinine <=1.5mg/dL
creatinine clearance >=50mL/min
6)PS(ECOG) 0-2
7)Sufficient oral intake
8)With written informed consent
9)Estimated life expectancy of at least 3 months

Key exclusion criteria

1)Active double cancer
2)Severe diarrhea
3)Symptomatic pulmonary fibrosis or interstitial pneumonia. Marked pleural or peritoneal effusion
4)Metastasis in central nervous system
5)para-aortic lymph node metastasis
6)Severe complications, such as ileus, heart failure and renal failure
7)Pregnant females, possibly pregnant females, females wishing to become pregnant and nursing mothers. Males that are currently attempting to produce a pregnancy
8)History of severe anaphylaxies
9)Active infection
10)Severe mental disorder
11)Patients under treatment with flucytosine, phenytoin or warfarin potassium
12)Inadequate physical condition, as diagnosed by primary physician

Target sample size

12


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masaji Tani

Organization

Wakayama Medical University, School of Medicine

Division name

Second Department of Surgery

Zip code


Address

811-1 Kimiidera,Wakayama 641-8510, Japan

TEL

073-447-2300

Email

srg2@wakayama-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Masaji Tani

Organization

Wakayama Medical University, School of Medicine

Division name

Second Department of Surgery

Zip code


Address

811-1 Kimiidera,Wakayama 641-8510, Japan

TEL

073-447-2300

Homepage URL


Email

srg2@wakayama-med.ac.jp


Sponsor or person

Institute

Wakayama Medical University, School of Medicine

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


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

2010 Year 06 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

Completed

Date of protocol fixation

2010 Year 04 Month 16 Day

Date of IRB


Anticipated trial start date

2010 Year 05 Month 01 Day

Last follow-up date

2013 Year 12 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2010 Year 06 Month 21 Day

Last modified on

2014 Year 05 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004517


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name