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

Email



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


Email

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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name