Unique ID issued by UMIN | UMIN000025747 |
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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 |
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.
Gemcitabine and TS-1 Trial-2
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.
Gemcitabine and TS-1 Trial-2
Japan |
Pancreatic cancer
Hepato-biliary-pancreatic medicine |
Malignancy
NO
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.
Safety,Efficacy
Exploratory
Phase II
Overall survival
Incidence rate of adverse event, incidence rate of serious adverse event, progression-free survival, response rate
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
NO
YES
Institution is considered as adjustment factor in dynamic allocation.
Central registration
2
Treatment
Medicine |
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.
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.
75 | years-old | <= |
Not applicable |
Male and Female
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.
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.
100
1st name | |
Middle name | |
Last name | Hiroshi Ishii |
National Hospital Organization Shikoku Cancer Center
Clinical Research Center
160 Kou, Minamiumemoto-machi, Matsuyama, Ehime, 791-0280, JAPAN
089-999-1111
hirishii@gmail.com
1st name | |
Middle name | |
Last name | Hiroshi Ishii |
National Hospital Organization Shikoku Cancer Center
Clinical Research Center
160 Kou, Minamiumemoto-machi, Matsuyama, Ehime, 791-0280, JAPAN
089-999-1111
hirishii@gmail.com
National Hospital Organization Shikoku Cancer Center
National Hospital Organization
Other
Japan
NO
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)
2017 | Year | 02 | Month | 18 | Day |
https://bmjopengastro.bmj.com/content/5/1/e000187.citation-tools
Unpublished
Terminated
2016 | Year | 12 | Month | 20 | Day |
2017 | Year | 02 | Month | 18 | Day |
2018 | Year | 02 | Month | 16 | Day |
2018 | Year | 02 | Month | 16 | Day |
2017 | Year | 01 | Month | 19 | Day |
2019 | Year | 01 | Month | 21 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029624
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