UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012634 |
|---|---|
| Receipt number | R000014772 |
| Scientific Title | A Randomised Phase II trial investigating the duration of adjuvant therapy(6 versus 12 months) with S-1 for patients after resection of pancreatic cancer |
| Date of disclosure of the study information | 2013/12/20 |
| Last modified on | 2017/06/23 14:14:40 |
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Basic information
Public title
A Randomised Phase II trial investigating the duration of adjuvant therapy(6 versus 12 months) with S-1 for patients after resection of pancreatic cancer
Acronym
Postoperative Adjuvant Chemotherapy S-1 : PACS-1
Scientific Title
A Randomised Phase II trial investigating the duration of adjuvant therapy(6 versus 12 months) with S-1 for patients after resection of pancreatic cancer
Scientific Title:Acronym
Postoperative Adjuvant Chemotherapy S-1 : PACS-1
Region
| Japan |
Condition
Condition
Resected pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of the duration of adjuvant therapy (6 versus 12 months) with S-1 for patients after resection of pancreatic cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
2-year overall survival rate
Key secondary outcomes
DFS, OS, Dose Intensity, Complete rate of each treatment point (3 and 6, 9, 12 months), Safety
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
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
S-1 40 mg/m2 is given orally twice a day for four weeks, followed by a two-week rest. This course is repeated until 6 months or to meet discontinuation criteria.
Interventions/Control_2
S-1 40 mg/m2 is given orally twice a day for four weeks, followed by a two-week rest. To be repeated until 12 months or to meet discontinuation criteria.
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) Patients with written informed consent
2) Patients who are judged to be suitable for receiving this protocol therapy by the physician
3) Resected cases with histologically proven invasive ductal carcinoma of the pancreas
4) According to the UICC 7th classification;
- Stage I or II, or III in whom celiac artery resection was performed
- R0 or R1
- Cancer negative for washing cytology of the abdominal cavity
5) No distant metastasis nor malignant ascites
6) Adequate oral intakes
7) Aged 20 years and older
8) An Eastern Cooperative Oncology Group performance status of 0 or 1
9) No prior history of chemotherapy nor radiation therapy within three years
10) Within 10 weeks after operation
11) Sufficient organ function of bone marrow, liver, and kidney:
12) Patients with laboratory data within 14days before enrollment as follows;
Leukocytes >= 3,000 /mm3 and <= 12,000 /mm3, Platelets >= 100,000 /mm3, Hemoglobin >= 8.0 g/dL, Serum total bilirubin <= 2.0 mg/dL, Serum aspartate aminotransferase (AST) <= 100 IU/L, Serum alanine aminotransferase (ALT) <= 100 IU/L, and Serum creatinine <= 1.2 mg/dL
Key exclusion criteria
1) Previously treated by chemotherapy for locally advanced pancreatic cancer
2) Prior history of S-1 therapy
3) History of serious drug hypersensitivity or a history of drug allergy
4) Patients with contraindication for the medication of S-1
5) Serious complications ( ex. interstitial pneumonitis, pulmonary fibrosis, renal failure, liver failure, intractable diabetes, intractable hypertension)
6) Recurrent disease before enrollment
7) Moderate or ascites or pleural effusion
8) Plumonary fibrosis or interstitial pneumonia diagnosed by chest X-ray.
9) Serious diarrhea
10) Myocardial infarction within six months
11) Active infection(fever up; over 38 degree)
12) Blood transfusion within 2 weeks before enrollment
13) Severe mental disorder
14) Active double cancer (synchronous double cancer or asynchronous double cancer with disease-free survival of 5 years or less).
15) Pregnant or lactating woman and man who hope for partner's pregnancy
16) Patients who need flucytosine, phenytoin or warfarin potassium.
17) Requiring continous steroid administration
18) Not appropriate for the study at the physician's assessment
Target sample size
170
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshihiko MAEHARA |
Organization
Graduate School of Medical Sciences, Kyushu University
Division name
Department of Surgery and Science
Zip code
Address
3-1-1, Maidashi, Higashi-Ku, Fukuoka 812-8582, Japan
TEL
092-642-5466
abesato@surg2.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Norifumi HARIMOTO |
Organization
Graduate School of Medical Sciences, Kyushu University
Division name
Department of Surgery and Science
Zip code
Address
3-1-1, Maidashi, Higashi-Ku, Fukuoka 812-8582, Japan
TEL
092-642-5466
Homepage URL
abesato@surg2.med.kyushu-u.ac.jp
Sponsor or person
Institute
Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University
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
九州大学病院（福岡県）、済生会福岡総合病院（福岡県）、九州中央病院（福岡県）、九州がんセンター（福岡県）、福岡市民病院（福岡県）、飯塚病院（福岡県）、大分赤十字病院（大分県）、大分県立病院（大分県）、別府医療センター（大分県）、熊本大学大学院生命科学研究部（熊本県）、済生会熊本病院（熊本県）、広島赤十字・原爆病院（広島県）、徳島大学大学院ヘルスバイオサイエンス研究部（徳島県）、松山赤十字病院（愛媛県）、東京慈恵会医科大学（東京都）、群馬大学大学院（群馬県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 12 | Month | 20 | 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
No longer recruiting
Date of protocol fixation
| 2013 | Year | 12 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 12 | Month | 20 | 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 | 12 | Month | 20 | Day |
Last modified on
| 2017 | Year | 06 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014772
