UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025747 |
|---|---|
| Receipt number | R000029624 |
| Scientific Title | A randomized controlled trial of gemcitabine hydrochloride plus S-1 combination (GS) therapy and gemcitabine hydrochloride (Gem) therapy alone for patients with pancreatic cancer who are 75 years or older. |
| Date of disclosure of the study information | 2017/02/18 |
| Last modified on | 2019/01/21 09:09:48 |
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Basic information
Public title
A randomized controlled trial of gemcitabine hydrochloride plus S-1 combination (GS) therapy and gemcitabine hydrochloride (Gem) therapy alone for patients with pancreatic cancer who are 75 years or older.
Acronym
Gemcitabine and TS-1 Trial-2
Scientific Title
A randomized controlled trial of gemcitabine hydrochloride plus S-1 combination (GS) therapy and gemcitabine hydrochloride (Gem) therapy alone for patients with pancreatic cancer who are 75 years or older.
Scientific Title:Acronym
Gemcitabine and TS-1 Trial-2
Region
| Japan |
Condition
Condition
Pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare the efficacy and safety of gemcitabine hydrochloride (Gem) plus S-1 combination therapy (GS therapy) with standard Gem therapy alone in patients with pancreatic cancer who are 75 years old or older in good performance status in a randomized controlled trial.
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
Incidence rate of adverse event, incidence rate of serious adverse event, progression-free survival, response rate
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Group A (a group for Gem therapy alone): Gem is intravenously administered at a dose of 1,000 mg/m^2/day in 30 minutes on day 1, day 8 and day 15 as 4 weeks (28 days) for 1 course, until it satisfies any of the discontinuation criteria. The observation period is the period from the start of treatment to the completion of the later of 6 courses and 24 weeks.
Interventions/Control_2
Group B (a group for GS therapy): Gem is intravenously administered at a dose of 1,000 mg/m^2/day in 30 minutes on day 1 and day 8. S-1 is orally administered at a dose according to body surface (60 mg, 80 mg or 100 mg/day) in 2 divided doses after breakfast and after supper for 14 days continuously, followed by the rest period of 7 days. Treatment is continued as 2 weeks (14 days) for 1 course until it satisfies any of the discontinuation criteria. The observation period is the period from the start of treatment to the completion of the later of 8 courses and 24 weeks.
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
| 75 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients who are diagnosed with adenocarcinoma in tissue biopsy or cytology and whose image diagnosis do not contradict any of papillary adenocarcinoma, tubular adenocarcinoma, poorly differentiated adenocarcinoma or adenous squamous cell carcinoma.
2. Patients who are diagnosed with either locally advanced (UICC T4N0-1 M0: stage III), distant metastasis (UICC M1: stage IV) or recurrent (after resection) pancreatic cancer in clinical and image diagnoses.
3. Patients without retention of body cavity fluid (pleural effusion, ascites) which requires puncture drainage on chest x-rays and abdominal CT.
4. Patients who are 75 years old or older at the time of registration.
5. Patients with performance status (ECOG) of grade 0 or 1.
6. Patients without a history of chemotherapy for pancreatic cancer.
7. Patients who have had rest period of a half year or more since the end of prior treatment of either chemotherapy or radiotherapy for other cancer types.
8. Patients who satisfies all of the following conditions.
1).White blood cell count => 3,000 /mm^3 and <= 12,000 /mm^3
2).Hemoglobin => 9.0 g/dL (without transfusion within 14 days until the time of registration)
3).Number of platelets => 10*10^4 /mm^3
4).Albumin => 3.0g/dL
5).Total bilirubin without preoperative biliary drainage: <= 2.0 mg/dL, with preoperative biliary drainage: <= 3.0 mg/dL
6).AST without preoperative biliary drainage: <= 100 IU/L, with preoperative biliary drainage <= 150 IU/L
7).ALT without preoperative biliary drainage: <= 100 IU/L, with preoperative biliary drainage: <= 150 IU/L
8).Creatinine clearance => 50 mL/min/body
9).CRP <= 2.0 mg/dL
9. Patients who provided written consents for this study by themselves.
Key exclusion criteria
1. Patients to whom gemcitabine hydrochloride plus nab-paclitaxel (brand name: Abraxane) can be introduced at the discretion of the attending doctor under consent of the patient.
2. Patients with active advanced multiple primary cancers with life expectancy within a half year.
3. Patients with a bacterial infection which requires systemic treatment by intravenous administration of antibiotic.
4. Patients with a complication of psychosis or psychiatric symptoms (including dementia) who are decided not suitable for participation in this study.
5. Patients who have undergone continuous systemic administration of steroids.
6. Patients with pulmonary fibrosis or interstitial pneumonia.
7. Patients with serious complications.
8. Patients with a complication of unstable angina or a history of myocardial infarction within 6 months.
9. Patients who require continuous administration of flucytosine, phenytoin and warfarin potassium.
10. Patients to whom neither iodine drug nor gadolinium can be used for drug allergy.
11. Patients for whom the principal investigator or other investigators decided not suitable for participation in this study.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Ishii |
Organization
National Hospital Organization Shikoku Cancer Center
Division name
Clinical Research Center
Zip code
Address
160 Kou, Minamiumemoto-machi, Matsuyama, Ehime, 791-0280, JAPAN
TEL
089-999-1111
hirishii@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Ishii |
Organization
National Hospital Organization Shikoku Cancer Center
Division name
Clinical Research Center
Zip code
Address
160 Kou, Minamiumemoto-machi, Matsuyama, Ehime, 791-0280, JAPAN
TEL
089-999-1111
Homepage URL
hirishii@gmail.com
Sponsor or person
Institute
National Hospital Organization Shikoku Cancer Center
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
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
北海道がんセンター(北海道)、水戸医療センター(茨城県)、高崎総合医療センター(群馬県)、渋川医療センター(群馬県)、まつもと医療センター(長野県)、敦賀医療センター(福井県)、京都医療センター(京都府)、大阪医療センター(大阪府)、神戸医療センター(兵庫県)、米子医療センター(鳥取県)、岡山医療センター(岡山県)、福山医療センター(広島県)、関門医療センター(山口県)、岩国医療センター(山口県)、四国がんセンター(愛媛県)、小倉医療センター(福岡県)、九州がんセンター(福岡県)、九州医療センター(福岡県)、熊本南病院(熊本県)、別府医療センター(大分県)、南九州病院(鹿児島県)、がん研究会有明病院(東京都)、神奈川県立がんセンター(神奈川県)、大阪府立成人病センター(大阪府)、横浜医療センター(神奈川県)
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 02 | Month | 18 | Day |
Related information
URL releasing protocol
https://bmjopengastro.bmj.com/content/5/1/e000187.citation-tools
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
| 2016 | Year | 12 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 02 | Month | 18 | Day |
Last follow-up date
| 2018 | Year | 02 | Month | 16 | Day |
Date of closure to data entry
| 2018 | Year | 02 | Month | 16 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 01 | Month | 19 | Day |
Last modified on
| 2019 | Year | 01 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029624
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