UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009936 |
|---|---|
| Receipt number | R000011638 |
| Scientific Title | Feasibility study of adjuvant chemotherapy with alternate-day administrations of S-1 in patients with resected pancreatic cancer |
| Date of disclosure of the study information | 2013/02/02 |
| Last modified on | 2018/08/15 15:01:06 |
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Basic information
Public title
Feasibility study of adjuvant chemotherapy with alternate-day administrations of S-1 in patients with resected pancreatic cancer
Acronym
Feasibility study of adjuvant alternate-day S-1 therapy for pancreatic cancer
Scientific Title
Feasibility study of adjuvant chemotherapy with alternate-day administrations of S-1 in patients with resected pancreatic cancer
Scientific Title:Acronym
Feasibility study of adjuvant alternate-day S-1 therapy for pancreatic cancer
Region
| Japan |
Condition
Condition
pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate treatment completion rate, efficacy and safety of alternate-day administrations of S-1 in patients with pancreatic cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Treatment completion rate
Key secondary outcomes
Overall Survival
Relapse-free Survival
Incidence and Severity of Adverse Events
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
S-1 is administered orally twice daily after morning and evening meals at a dose of 80-150 mg/day on Mondays, Wednesdays, Fridays and Sundays. The study treatment is repeated for 24 weeks.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Resected cases with histologically proven invasive ductal carcinoma of the pancreas
2) According to the UICC classification,
a) Stage I, II, or III
b) R0 or R1
3) No distant metastasis
4) No prior history of chemotherapy nor radiation therapy for pancreatic cancer
5) Age of 20 years or older
6) An Eastern Cooperative Oncology Group performance status of 0 or 1
7) Sufficient organ function:
Neutrophil count >= 1,500 /mm3
Platelet count >= 100,000 /mm3
Hemoglobin >= 9.0 g/dL
Serum total bilirubin <= 2.0 mg/dL,
AST <= 150 IU/L
ALT <= 150 IU/L
Serum creatinine <= 1.2 mg/dL
Creatinine clearance >= 50 mL/min
8) Within 10 weeks after surgery
9) Adequate oral intakes
10) Written informed consent
Key exclusion criteria
1) Contraindication of S-1
2) Active double cancer (synchronous double cancer or asynchronous double cancer with disease-free duration of 3 years or less). Carcinoma in situ and lesions of intramucosal carcinoma will not be included in active double cancer and will be permitted for registration
3)Pulmonary fibrosis or interstitial pneumonia
4)Watery diarrhea
5)Active infections (e.g. patients with pyrexia of 38 degree centigrade or greater), excluding viral hepatitis
6)Serious complications (e.g. heart failure, renal failure, hepatic failure, hemorrhagic peptic ulcer, intestinal paralysis, intestinal obstruction or poorly controlled diabetes).
7)Moderate or severe (requiring drainage) ascites or pleural effusion
8) Current use of flucytosine
9) Pregnant females, possibly pregnant females, females wishing to become pregnant and nursing mothers. Males that are currently attempting to produce a pregnancy.
10) Severe mental disorder.
11) Severe drug allergies.
12) Positive HBs antigen and/or HCV antibody.
13)Physician concludes that the patient's participation in this trial is inappropriate.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Seiichi Takenoshita |
Organization
Fukushima Medical University Hospital, School of medicine
Division name
Department of Organ Regulatory Surgery
Zip code
Address
1 Hikariga-oka, Fukushima City, Fukushima Prefecture 960-1295 JAPAN
TEL
024-547-1111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tatsuo Shimura |
Organization
Fukushima Medical University Hospital, School of medicine
Division name
Department of Organ Regulatory Surgery
Zip code
Address
1 Hikariga-oka, Fukushima City, Fukushima Prefecture 960-1295 JAPAN
TEL
024-547-1111
Homepage URL
Sponsor or person
Institute
Fukushima Medical University Hospital, School of medicine
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
福島県立医科大学附属病院(福島県)
大原綜合病院（福島県）
北福島医療センター（福島県）
社会保険二本松病院（福島県）
星総合病院（福島県）
寿泉堂綜合病院（福島県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 02 | Month | 02 | 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
Terminated
Date of protocol fixation
| 2012 | Year | 12 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 05 | 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
| 2013 | Year | 02 | Month | 02 | Day |
Last modified on
| 2018 | Year | 08 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011638
