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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003768
Receipt No. R000004562
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)
Date of disclosure of the study information 2010/06/17
Last modified on 2013/01/17

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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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