UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006811
Receipt number R000007809
Scientific Title Randomized phaseII study of S-1 and concurrent radiotherapy with versus without induction chemotherapy for locally advanced pancreatic cancer. (JCOG1106)
Date of disclosure of the study information 2011/12/01
Last modified on 2022/08/30 15:59:39

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Basic information

Public title

Randomized phaseII study of S-1 and concurrent radiotherapy with versus without induction chemotherapy for locally advanced pancreatic cancer. (JCOG1106)

Acronym

Randomized phaseII study of S-1 and concurrent radiotherapy with versus without induction chemotherapy for locally advanced pancreatic cancer.
(JCOG1106)

Scientific Title

Randomized phaseII study of S-1 and concurrent radiotherapy with versus without induction chemotherapy for locally advanced pancreatic cancer. (JCOG1106)

Scientific Title:Acronym

Randomized phaseII study of S-1 and concurrent radiotherapy with versus without induction chemotherapy for locally advanced pancreatic cancer.
(JCOG1106)

Region

Japan


Condition

Condition

locally advanced pancreatic cancer

Classification by specialty

Hepato-biliary-pancreatic medicine Hematology and clinical oncology Radiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to evaluate efficacy and safety of S-1 and concurrent radiotherapy with or without induction chemotherapy for locally advanced pancreatic cancer patients.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

overall survival

Key secondary outcomes

CA19-9 response, distant metastasis-free survival, progression-free survival, adverse events, delayed toxicity, treatment-related death, early death, grade 4 non-hematological toxicity


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

NO

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

A:Patients receive concurrent radiotherapy with S-1 followed by additinoal chemotherapy until obvious evidence of disease progression, patient refusal, 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
Additional chemotherapy:
Gemcitabine; 1000 mg/m2/day, days 1, 8, and 15 every 4 weeks

Interventions/Control_2

B:Patients receive induction chemotherapy followed by concurrent radiotherapy with S-1 and additinoal chemotherapy until obvious evidence of disease progression, patient refusal, or unacceptable toxicity.
Induction chemotherapy:
Gemcitabine; 1000 mg/m2/day, days 1, 8, and 15 every 4 weeks
Concurrent radiotherapy with S-1:
S-1; 80mg/m2 on the irradiated day
Radiotherapy; a total dose of 50.4 Gy in 28 fractions
Additional chemotherapy:
Gemcitabine; 1000 mg/m2/day, days 1, 8, and 15 every 4 weeks

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) Histologically or cytologically proven adenocarcinoma and consistent with papillary adenocarcinoma, tubular adenocarcinoma, poor differentiated adenocarcinoma, or adenosquamous carcinoma by diagnostic imaging
2) Without obvious organ metastasis (UICC-M0) by diagnostic imaging
3) Diagnosed as UICC-T4 by abdominal CT or MRI
4) All pancreas lesions and lymph node metastases are included in the radiation field, 10 x 10 cm
5) Without ascites/pleural effusion by abdominal CT/chest X-ray
6) Without gastroduodenal ulcer (except for ulcer scar)
7) Without obvious direct invasion to digestive tract
8) Aged 20 to 80 years old
9) ECOG PS of 0 or 1
10) No prior surgical treatment for pancreatic cancer (except for exploraratory laparotomy, choledochojejunostomy and gastrojejunostomy)
11) No previous chemotherapy or radiotherapy against any other malignancies
12) Adequate organ functions
13) Written informed consent"

Key exclusion criteria

1) Interstitial pneumonia or fibroid lung
2) Watery diarrhea
3) Severe complication, such as heart disease, renal disease, and hepatic disease
4) Patients requiring the administration of flucytosine, phenytoin or warfarin potassium
5) Simultaneous or metachronous (within 5 years) double cancers, with the exception of intramucosal tumor curable with local therapy
6) Active infection requiring systemic therapy
7) Fever over 38 degrees Celsius
8) Pregnant or lactating women or women of childbearing potential and men who want to get partner pregnant
9) Psychosis
10) Patients requiring systemic steroids medication
11) Patients who can' t receive neither iodic drug nor gadolinium because of drug allergy "

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Junji FURUSE

Organization

Kyorin University School of Medicine

Division name

Divison of Mediacl Oncology

Zip code


Address

6-20-2, Shinkawa, Mitaka, Tokyo, 181-8611, Japan

TEL

0422-44-1865

Email

JCOG_sir@ml.jcog.jp


Public contact

Name of contact person

1st name
Middle name
Last name Akira FUKUTOMI

Organization

JCOG1106 Coordinating Office

Division name

Shizuoka Cancer Center, Division of GI Oncology

Zip code


Address

1007 Shimonagakubo Nagaizumi-cho Sunto-gun, Shizuoka, 411-8777

TEL

03-3542-2511

Homepage URL

http://www.jcog.jp/

Email

JCOG_sir@ml.jcog.jp


Sponsor or person

Institute

Japan Clinical Oncology Group (JCOG)

Institute

Department

Personal name



Funding Source

Organization

Labour and Welfare

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan


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

札幌厚生病院(北海道)
栃木県立がんセンター(栃木県)
自治医科大学(栃木県)
埼玉県立がんセンター(埼玉県)
国立がん研究センター東病院(千葉県)
千葉県がんセンター(千葉県)
千葉大学医学部(千葉県)
国立がん研究センター中央病院(東京都)
杏林大学医学部(東京都)
東京女子医科大学(東京都)
がん研究会有明病院(東京都)
帝京大学医学部(東京都)
北里大学東病院(神奈川県)
東海大学医学部(神奈川県)
神奈川県立病院機構(神奈川県)
神奈川県立がんセンター(神奈川県)
横浜市立大学附属市民総合医療センター(神奈川県)
富山大学附属病院(富山県)
静岡県立静岡がんセンター(静岡県)
愛知県がんセンター中央病院(愛知県)
大阪府立病院機構(大阪府)
大阪府立成人病センター(大阪府)
国立病院機構大阪医療センター(大阪府)
関西医科大学附属枚方病院(大阪府)
神戸大学医学部(兵庫県)
国立病院機構四国がんセンター(愛媛県)
国立病院機構九州がんセンター(福岡県)
九州大学病院(福岡県)


Other administrative information

Date of disclosure of the study information

2011 Year 12 Month 01 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

2011 Year 10 Month 14 Day

Date of IRB

2011 Year 11 Month 28 Day

Anticipated trial start date

2011 Year 12 Month 01 Day

Last follow-up date

2015 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

2011 Year 12 Month 01 Day

Last modified on

2022 Year 08 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007809


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name