UMIN-CTR Clinical Trial

Basic information
Public title	A phase II trial of adjuvant chemotherapy with 5-FU liver perfusion chemotherapy via the portal vein followed by gemcitabine plus S-1 (F-GS therapy) for patients with resectable pancreatic cancer (CCOG-1001)
Acronym	A phase II trial of adjuvant chemotherapy with 5-FU liver perfusion chemotherapy via the portal vein followed by gemcitabine plus S-1 (F-GS therapy) for patients with resectable pancreatic cancer
Scientific Title	A phase II trial of adjuvant chemotherapy with 5-FU liver perfusion chemotherapy via the portal vein followed by gemcitabine plus S-1 (F-GS therapy) for patients with resectable pancreatic cancer (CCOG-1001)
Scientific Title:Acronym	A phase II trial of adjuvant chemotherapy with 5-FU liver perfusion chemotherapy via the portal vein followed by gemcitabine plus S-1 (F-GS therapy) for patients with resectable pancreatic cancer
Region	Japan

Condition
Condition	resectable pancreatic cancer
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and feasibility for 5-FU liver perfusion chemotherapy followed by gemcitabine plus S-1 (F-GS therapy) as adjuvant chemotherapy for resectable pancreatic cancer
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	disease free survival, adverse effect, proportion of treatment completion, relative dose intensity, rate of liver metastasis

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Adjuvant chemotherapy with 5-FU liver perfusion chemotherapy via the portal vein followed by gemcitabine plus S-1
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) invasive ductal carcinoma of the pancreas 2) resectable (R0/1) stage III or IV pancreatic cancer (classification of Japan Pancreas Society) 3) no prior therapy except pancreatectomy 4) ECOG PS: 0-1 5) sufficient organ functions within a week before surgery WBC > 4000/mm3, < 12000/mm3 Neutrophil > 2000/mm3 Plt > 100000/mm3 Hb > 9.5g/dl T-Bil < 2.0mg/dl AST,ALT < 150 IU/L Creatinine clearance > 60mL/min 6) no liver damage, Child-Pugh Grade A 7) no abnormal electrocardiogram 8) enable to oral intake 9) written informed consent
Key exclusion criteria	1) serious intra- or postoperative complications 2) regular use of fenitoin, warfarin or frucitocin 3) systemic administration of other fluorouracil 4) intractable watery diarrhea 5) severe psychological disease 6) active infection 7) serious complications (bowel paralysis, bowel obstruction, uncontrollable diabetes mellitus, heart failure, renal failure, active peptic ulcer, deep venous thrombosis and so on) 8) serious myelosuppression 9) interstitial pneumonia or pulmonary fibrosis 10) radiotherapy to the chest 11) pleural effusion or ascites 12) active malignancy in other organ 13) allergic reaction for gemcitabine or S-1 14) chronic liver damage 15) impossible insertion of the catheter to the portal vein 16) pregnant or breast feeding 17) Patients judged inappropriate for the study by the physicians
Target sample size	45

Research contact person
Name of lead principal investigator	1st name Middle name Last name Akimasa Nakao
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Surgery II (Gastroenterological surgery)
Zip code
Address	65,Tsurumai-cho,Showa-ku,Nagoya,Aichi
TEL
Email

Public contact
Name of contact person	1st name Middle name Last name Tsutomu Fujii
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Surgery II (Gastroenterological surgery)
Zip code
Address
TEL
Homepage URL
Email	fjt@med.nagoya-u.ac.jp

Sponsor
Institute	Chubu Clinical Oncology Group
Institute
Department

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	2010 Year 06 Month 17 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	2010 Year 02 Month 15 Day
Date of IRB
Anticipated trial start date	2010 Year 06 Month 01 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	2010 Year 06 Month 17 Day
Last modified on	2013 Year 01 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004562

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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