UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007452
Receipt number R000008783
Scientific Title A feasibility study of TS-1 schedule modification in elderly patients with metastatic and locally advanced pancreatic cancer
Date of disclosure of the study information 2012/03/05
Last modified on 2012/03/05 21:56:14

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Basic information

Public title

A feasibility study of TS-1 schedule modification in elderly patients with metastatic and locally advanced pancreatic cancer

Acronym

A feasibility study of TS-1 schedule modification in elderly patients with metastatic and locally advanced pancreatic cancer

Scientific Title

A feasibility study of TS-1 schedule modification in elderly patients with metastatic and locally advanced pancreatic cancer

Scientific Title:Acronym

A feasibility study of TS-1 schedule modification in elderly 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

75 years-old <=

Age-upper limit


Not applicable

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: 75 years or older.
5) ECOG Performance Status (PS) of 2.
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 or person

Institute

Department of surgery, Kansai Medical 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


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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008783


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name