UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003768 |
|---|---|
| Receipt number | 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 14:36:43 |
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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
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
fjt@med.nagoya-u.ac.jp
Sponsor or person
Institute
Chubu Clinical Oncology Group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004562
