UMIN-CTR Clinical Trial

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
Institute	Japan Clinical Oncology Group (JCOG)
Institute
Department

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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007809