UMIN-CTR Clinical Trial

Public title

A clinical trial of S-1 and concurrent radiotherapy for locally advanced pancreatic cancer

Acronym

S-1 and concurrent radiotherapy for locally advanced pancreatic cancer

Scientific Title

A clinical trial of S-1 and concurrent radiotherapy for locally advanced pancreatic cancer

Scientific Title:Acronym

S-1 and concurrent radiotherapy for locally advanced pancreatic cancer

Region

Japan

Condition

Locally advanced pancreatic cancer

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

The aim of this study is to evaluate the efficacy and toxicity of S-1 and concurrent radiotherapy for locally advanced pancreatic cancer.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Developmental phase

Primary outcomes

Survival and adverse events

Key secondary outcomes

Progression free survival, response rate.

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Concurrent radiotherapy with S-1 and maintenance therapy of S-1 was administered until disease progression or unacceptable toxicity.
Concurrent radiotherapy with S-1:
S-1; 80mg/m2 on the irradiated day.
Radiotherapy; a total dose of 50.4 Gy in 28 fractions over 5.5 weeks.
Maintenance therapy of S-1:
80mg/m2 for 28 days, followed by a rest period of 14 days.

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

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Patients eligible for study entry had locally advanced pancreatic cancer.
Eligibility criteria were:
1)Histologically or cytologically proven adenocarcinoma
2)No prior treatment for pancreatic cancer
3)All pancreas lesions and lymph node metastases are included in the radiation field, 10 x 10 cm
4)Aged 20 years or over
5)An Eastern Cooperative Oncology Group performance status of 0-2
6)Adequate oral intakes
7)Sufficient organ function: leukocytes >= 3,500 /mm3, hemoglobin >= 9 g/dL, platelets >= 100,000 /mm3, serum albumin >= 3.0 g/dL, serum total bilirubin <= 2.0 mg/dL (or 3.0mg/dL if biliary drainage were present), serum transaminases (aspartate aminotransferase (AST) / alanine aminotransferase (ALT)) <= 100 U/L (or 150U/L if biliary drainage were present), and serum creatinine <= upper normal limit
8)Written informed consent.

Key exclusion criteria

1)Watery diarrhea
2)Use of phenytoin, warfarin potassium, or flucytosine
3)Pleural effusion or ascites
4)Active infection
5)Active concomitant malignancy
6)Active gastroduodenal ulcer
7)Severe complication, such as heart disease, renal disease, and hepatic disease
8)Severe mental disorder
9) Severe allergic reaction to drug
10)Active concomitant malignancy, pregnant and lactating females, and females of childbearing age unless using effective contraception

Target sample size

10

Name of lead principal investigator

1st name
Middle name
Last name	Tatsuichi An MD

Organization

BELL LAND General Hospital

Division name

Department of Gastroenterology

Zip code

Address

500-3 Higashiyama, Naka-ku,Sakai-city, Osaka 599-8247, Japan

TEL

072-234-2001

Email

Name of contact person

1st name
Middle name
Last name	Yoshinobu Hasegawa, MD.

Organization

S-1 Radiation Office

Division name

Department of Gastroenterology, BELL LAND General Hospital

Zip code

Address

500-3 Higashiyama, Naka-ku,Sakai-city, Osaka 599-8247, Japan

TEL

072-234-2001

Homepage URL

Email

h-yoshitomo@kb3.so-net.ne.jp

Institute

Department of Gastroenterology, BELL LAND General Hospital

Institute

Department

Personal name

Organization

Department of Gastroenterology, BELL LAND General Hospital

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

ベルランド総合病院（大阪府）/ BELL LAND General Hospital（Osaka）

Date of disclosure of the study information

2011

Year

04

Month

11

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Enrolling by invitation

Date of protocol fixation

2011

Year

01

Month

01

Day

Date of IRB

Anticipated trial start date

2011

Year

01

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2011

Year

04

Month

10

Day

Last modified on

2011

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=R000005923