UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010088
Receipt number 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 09:27:56

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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 or person

Institute

Fukushima medical University Hospital, School of medicine

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

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

Value
https://center6.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