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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000010088
Receipt No. R000011817
Scientific Title Phase II study of Gemcitabine plus alternate-day administrations of S-1 in patients with unresectable advanced pancreatic cancer.
Date of disclosure of the study information 2013/02/21
Last modified on 2013/02/21

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Basic information
Public title Phase II study of Gemcitabine plus alternate-day administrations of S-1 in patients with unresectable advanced pancreatic cancer.
Acronym Phase II study of GEM + alternate-day S-1 treatment for pancreatic cancer.
Scientific Title Phase II study of Gemcitabine plus alternate-day administrations of S-1 in patients with unresectable advanced pancreatic cancer.
Scientific Title:Acronym Phase II study of GEM + alternate-day S-1 treatment 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 the efficacy and safety of Gemcitabine plus alternate-day administrations of S-1 in patients with advanced unresectable pancreatic cancer.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Response Rate
Key secondary outcomes Overall Survival
Progression-free Survival
Disease Control Rate
Safety

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 GEM 1,000mg/m2 day1
TS-1 50-120mg/day alternate-day (Mondays, Wednesdays, Fridays and Sundays)
q2W
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)Either histologically or cytologically confirmed adenocarcinoma and adenosquamous carcinoma. Or radiologically confirmed pancreatic cancer.
(2)Unresectable pancreatic cancer (including locally advanced or metastatic pancreatic cancer).
(3)Patients with no previous treatment (radiotherapy, chemotherapy etc) for pancreatic cancer, except resection.
Palliative bypass operation and biliary stent will be permitted.
Intra-operative radiotherapy during resection of pancreatic cancer will be permitted, although registration must be done at least 4 weeks after the radiotherapy.
Patients who have undergone preoperative/postoperative adjuvant chemotherapy can be enrolled if relapse is diagnosed beyond 24 weeks (168days) after the final administration.
(4)Patients with measurable lesions
(5)Age of 20 years or older.
(6)ECOG Performance Status (PS) of 0 or 1.
(7)Adequate major organ functions within 14 days before registration, as defined below:
White blood cell count >= 3500/mm3
Neutrophil count >= 2000/mm3
Hemoglobin >= 9.0 g/dL
Platelet count >= 100,000/mm3
Total bilirubin <= 2.0 mg/dL*
*3.0 mg/dL in patients treated by biliary drainage for obstructive jaundice.
AST and ALT <= 150 U/L
Serum creatinine <= 1.2 mg/dL
Creatinine clearance <= 50mL/min.
(8) Sufficient oral intake.
(9) No clinically abnormal ECG findings within 28 days (4 weeks) before registration.
(10) Patients must have signed an informed consent document.
Key exclusion criteria (1) Contraindication of Gemsitabine and S-1.
(2) Pulmonary fibrosis or interstitial pneumonia (to be confirmed by chest X-ray within 28 days before registration).
(3)Watery diarrhea.
(4)Active infections (e.g. patients with pyrexia of 38 degree centigrade or greater), excluding viral hepatitis.
(5)Serious complications (e.g. heart failure, renal failure, hepatic failure, hemorrhagic peptic ulcer, intestinal paralysis, intestinal obstruction or poorly controlled diabetes).
(6)Moderate or severe (requiring drainage) ascites or pleural effusion requiring treatment.
(7) Metastasis in the CNS.
(8) 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.
(9) Current use of flucytosine, phenytoin or warfarin potassium.
(10) For female subject: Positive Pregnancy test, presently breast feeding or unwilling to use effective contraceptive measure. For male subjects: intent to procreate during the duration of the study or unwilling to use effective contraceptive measure.
(11) Severe mental disorder.
(12) Severe drug allergies.
(13)Decision of not eligible determined by principle investigator or attending doctor.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mitsukazu Gotoh
Organization Fukushima Medical University, School of medicine
Division name Department of Regenerative Surgery
Zip code
Address 1 Hikariga-oka, Fukushima City, Fukushima Prefecture 960-1295 JAPAN
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Takao Tsuchiya
Organization Fukushima Medical University Hospital, School of medicine
Division name Department of Regenerative Surgery
Zip code
Address 1 Hikariga-oka, Fukushima City, Fukushima Prefecture 960-1295 JAPAN
TEL 024-547-1111
Homepage URL
Email

Sponsor
Institute Fukushima medical University Hospital, School of medicine
Institute
Department

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
Email

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
2013 Year 02 Month 21 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 Open public recruiting
Date of protocol fixation
2012 Year 12 Month 10 Day
Date of IRB
Anticipated trial start date
2013 Year 02 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 21 Day
Last modified on
2013 Year 02 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011817

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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