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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000007451
Receipt No. R000008782
Scientific Title A feasibility study of TS-1 schedule modification in patients with metastatic and locally advanced pancreatic cancer
Date of disclosure of the study information 2012/03/05
Last modified on 2012/03/05

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Basic information
Public title A feasibility study of TS-1 schedule modification in patients with metastatic and locally advanced pancreatic cancer
Acronym A feasibility study of TS-1 schedule modification in patients with metastatic and locally advanced pancreatic cancer
Scientific Title A feasibility study of TS-1 schedule modification in patients with metastatic and locally advanced pancreatic cancer
Scientific Title:Acronym A feasibility study of TS-1 schedule modification in patients with metastatic and locally advanced pancreatic cancer
Region
Japan

Condition
Condition Metastatic or locally advanced pancreatic cancer
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the feasibility, efficacy, and safety of TS-1 Schedule modification for 1st-line metastatic and locally advanced pancreatic cancer
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Administration Rate of TS-1
Key secondary outcomes Response rate(RR), Disease control rate(DCR), Progression-free survival(PFS), Overall survival(OS), Time to treatment failure(TTF), Adverse event, Receive rate of the 2nd line treatment, Clinical benefit response(CBR), QOL(EQ-5D)

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 TS-1 was administered orally at 40 mg/m2 twice daily for 28 days with a rest period of 14 days as one course.
When it corresponds to administration change criteria, TS-1 was administered orally at 40 mg/m2 twice daily for 5 days with a rest period of 2 days.
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
75 years-old >
Gender Male and Female
Key inclusion criteria 1) Pancreatic carcinoma histologically determined to be adenocarcinoma or adenosquamous carcinoma.
2) Advanced unresectable pancreatic (including pancreatic cancer with local progression and recurrent pancreatic cancer). Presence/absence of measurable lesions is not considered. Patients with measurable lesions must undergo diagnostic imaging tests within 28 days before registration.
3) Patients with no previous treatment (radiotherapy, chemotherapy etc) for pancreatic cancer, except resection. Intra-operative radiotherapy during resection of pancreatic cancer will be permitted, although registration must occur at least 4 weeks after the radiotherapy. Patients that have undergone preoperative/postoperative adjuvant chemotherapy may be enrolled if relapse is diagnosed beyond week 24 after the final administration (on day 169 when the day following the final day is set as day 1).
4) Age: 20 years to 74 years.
5) ECOG Performance Status (PS) of 0 or 1.
6) Sufficient function of major organs as defined below. (The following criteria are satisfied in laboratory tests conducted within 14 days before registration. Laboratory tests conducted 2 weeks before registration (on the same weekday) will be included.)
White blood cell count &#8805; 3500/mm3
Neutrophil count &#8805; 2000/mm3
Hemoglobin &#8805; 9.0 g/dL
Platelet count &#8805; 100000/mm3
Total bilirubin&#8804; 2.0 mg/dL*
*&#8804; 3.0 mg/dL in patients treated by biliary drainage for obstructive jaundice.
AST and ALT&#8804; 150 U/L
Serum creatinine &#8804; 1.2 mg/dL
Creatinine clearance &#8805; 50mL/min.**
**Measured values will be used if available. Otherwise, values calculated by the Cockcroft-Gault method will be used.Formula for estimation:body weight (kg) x [140 - age (years) / 72 x serum creatinine (mg/dL)] *Estimated value will be multiplied by 0.85 for females.
7) Able to take capsules orally.
8) No clinically abnormal ECG findings within 28 days (4 weeks)before registration.
9) Voluntarily signed the written consent form.
Key exclusion criteria 1) Pulmonary fibrosis or interstitial pneumonia (to be confirmed by chest X-ray within 28 days before enrollment).
2) Watery diarrhea.
3) Active infections (e.g. patients with pyrexia of 38 degrees C or greater), excluding viral hepatitis.
4) Serious complications (e.g. heart failure, renal failure,hepatic failure, haemorrhagic peptic ulcer, intestinal paralysis, intestinal obstruction or poorly controlled diabetes).
5) Moderate or severe (requiring drainage) ascites or pleural effusion requiring treatment.
6) Metastasis in the CNS.
7) 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.
8) Patients under treatment with flucytosine, phenytoin or warfarin potassium.
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) Judged ineligible by physicians for participation in the study from a safety viewpoint.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroaki yanagimoto
Organization Kansai Medical University
Division name Department of surgery
Zip code
Address 2-3-1 Shinmachi, Hirakata-city, Osaka.
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kansai Medical University
Division name Department of surgery
Zip code
Address 2-3-1 Shinmachi, Hirakata-city, Osaka.
TEL
Homepage URL
Email

Sponsor
Institute Department of surgery, Kansai Medical University.
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
2012 Year 03 Month 05 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
2011 Year 12 Month 09 Day
Date of IRB
Anticipated trial start date
2012 Year 01 Month 01 Day
Last follow-up date
2014 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 03 Month 05 Day
Last modified on
2012 Year 03 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008782

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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