UMIN-CTR Clinical Trial

Public title

Feasibility study of adjuvant chemotherapy with alternate-day administrations of S-1 in patients with resected pancreatic cancer

Acronym

Feasibility study of adjuvant alternate-day S-1 therapy for pancreatic cancer

Scientific Title

Feasibility study of adjuvant chemotherapy with alternate-day administrations of S-1 in patients with resected pancreatic cancer

Scientific Title:Acronym

Feasibility study of adjuvant alternate-day S-1 therapy for pancreatic cancer

Region

Japan

Condition

pancreatic cancer

Classification by specialty

Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate treatment completion rate, efficacy and safety of alternate-day administrations of S-1 in patients with pancreatic cancer

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Phase II

Primary outcomes

Treatment completion rate

Key secondary outcomes

Overall Survival
Relapse-free Survival
Incidence and Severity of Adverse Events

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

S-1 is administered orally twice daily after morning and evening meals at a dose of 80-150 mg/day on Mondays, Wednesdays, Fridays and Sundays. The study treatment is repeated for 24 weeks.

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

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) Resected cases with histologically proven invasive ductal carcinoma of the pancreas
2) According to the UICC classification,
a) Stage I, II, or III
b) R0 or R1
3) No distant metastasis
4) No prior history of chemotherapy nor radiation therapy for pancreatic cancer
5) Age of 20 years or older
6) An Eastern Cooperative Oncology Group performance status of 0 or 1
7) Sufficient organ function:
Neutrophil count >= 1,500 /mm3
Platelet count >= 100,000 /mm3
Hemoglobin >= 9.0 g/dL
Serum total bilirubin <= 2.0 mg/dL,
AST <= 150 IU/L
ALT <= 150 IU/L
Serum creatinine <= 1.2 mg/dL
Creatinine clearance >= 50 mL/min
8) Within 10 weeks after surgery
9) Adequate oral intakes
10) Written informed consent

Key exclusion criteria

1) Contraindication of S-1
2) 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
3)Pulmonary fibrosis or interstitial pneumonia
4)Watery diarrhea
5)Active infections (e.g. patients with pyrexia of 38 degree centigrade or greater), excluding viral hepatitis
6)Serious complications (e.g. heart failure, renal failure, hepatic failure, hemorrhagic peptic ulcer, intestinal paralysis, intestinal obstruction or poorly controlled diabetes).
7)Moderate or severe (requiring drainage) ascites or pleural effusion
8) Current use of flucytosine
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) Severe drug allergies.
12) Positive HBs antigen and/or HCV antibody.
13)Physician concludes that the patient's participation in this trial is inappropriate.

Target sample size

30

Name of lead principal investigator

1st name
Middle name
Last name	Seiichi Takenoshita

Organization

Fukushima Medical University Hospital, School of medicine

Division name

Department of Organ Regulatory Surgery

Zip code

Address

1 Hikariga-oka, Fukushima City, Fukushima Prefecture 960-1295 JAPAN

TEL

024-547-1111

Email

Name of contact person

1st name
Middle name
Last name	Tatsuo Shimura

Organization

Fukushima Medical University Hospital, School of medicine

Division name

Department of Organ Regulatory Surgery

Zip code

Address

1 Hikariga-oka, Fukushima City, Fukushima Prefecture 960-1295 JAPAN

TEL

024-547-1111

Homepage URL

Email

Institute

Fukushima Medical University Hospital, School of medicine

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

福島県立医科大学附属病院(福島県)
大原綜合病院（福島県）
北福島医療センター（福島県）
社会保険二本松病院（福島県）
星総合病院（福島県）
寿泉堂綜合病院（福島県）

Date of disclosure of the study information

2013

Year

02

Month

02

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Terminated

Date of protocol fixation

2012

Year

12

Month

10

Day

Date of IRB

Anticipated trial start date

2013

Year

05

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2013

Year

02

Month

02

Day

Last modified on

2018

Year

08

Month

15

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011638