UMIN-CTR Clinical Trial

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

locally advanced pancreatic cancer

Classification by specialty

Hepato-biliary-pancreatic medicine	Hematology and clinical oncology	Radiology

Classification by malignancy

Malignancy

Genomic information

NO

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

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

Study type

Interventional

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

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

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

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

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

Institute

Japan Clinical Oncology Group (JCOG)

Institute

Department

Personal name

Organization

Labour and Welfare

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

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）

Date of disclosure of the study information

2011

Year

12

Month

01

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

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 related 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