UMIN-CTR Clinical Trial

Public title

Feasibility Study of adjuvant chemotherapy of S-1/Oxaliplatin for patients with Stage III gastric cancer patients

Acronym

Feasibility Study of adjuvant chemotherapy of S-1/Oxaliplatin for patients with StageIII gastric cancer patients

Scientific Title

Feasibility Study of adjuvant chemotherapy of S-1/Oxaliplatin for patients with Stage III gastric cancer patients

Scientific Title:Acronym

Feasibility Study of adjuvant chemotherapy of S-1/Oxaliplatin for patients with StageIII gastric cancer patients

Region

Japan

Condition

Gastric cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

We investigate the tolerability of S-1/oxaliplatin combination adjuvant chemotherapy for Stage III gastric cancer patients after D2 gastrectomy.

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Treatment completion rate of up to protocol treatment 5 courses.

Key secondary outcomes

Adverse events occurrence rate

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

cycle
S-1:80-120mg/day.
2-4 cycle
S-1:80-120mg/day.
S-1 was given orally daily 2 weeks of 3week-cycle.Oxaliplatin 100mg/m2 was administered first cycle of 3 week-cycle as same schedule of S-1.

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

80

years-old

>=

Gender

Male and Female

Key inclusion criteria

1) Histological proven gastric cancer
2) Surgical operated by D2 lymphadenectomy and curability A
3) Clinical Stage IIIA,IIIB,IIIC(T2N3, T3N2-3, T4aN1-3, T4bN0-3) according to Japanese Classification of Gastric Cancer 14th edition
4) Age 20-80 years
5) No pretreatment (radiotherapy, chemotherapy, hormone therapy etc.) except surgery
6) Capable of protocol therapy within 56 days after gastrectomy.
7) PS(ECOG) 0 or 1
8) Capable oral food uptake.
9) Clear to the criteria as below within 14days after registration.
Hemoglobin:> 9.0 g/dL
Leukocyte: >3,000 /mm3 <12,000 /mm3
Neutrophil: >1,500 /mm3
Blood platelet count: >100,000/mm3
Total bilirubin: <1.5mg/dl
AST(GOT) ALT(GPT): <100 IU/L
Creatinine clearance: >60 mL/min
10) Capable to have given written informed consent to participate in this study

Key exclusion criteria

1) Active synchronous metachronous malignancy with longer than 5year interval period without below written cases
Carcinoma in situ of cervical cancer and focal cancer in adenoma of colorectal cancer.
2) Contraindication of S-1 and Oxaliplatin
3) Regular use of flucytosine, phenytoin or warfarin potassium
4) Active infection with over 38 degree fever
5) History of serious drug hypersensitivity
6) Any other serious illness or medical conditions including interstitial paresis, intestinal obstruction, pneumonitis, pulmonary fibrosis, uncontrolled diabetes, renal failure, liver failure.
7) HIV positive or active hepatitis
8) Severe diarrhea (over 4 times/day or watery diarrhea)
9) Pregnancy or lactation
10) Male intension that get with child
11) Patients who are recognized as inadequate patients by doctor with responsibility in this study.

Target sample size

25

Name of lead principal investigator

1st name
Middle name
Last name	Kinji Kamiya

Organization

Hamamatsu University Hospital

Division name

2nd department of surgery

Zip code

Address

1-20-1 Handayama Higashi-ku Hamamatsu City Shizuoka prif. Japan 431-3192

TEL

053-435-2279

Email

kamikin@hama-med.ac.jp

Name of contact person

1st name
Middle name
Last name	Kinji Kamiya

Organization

Hamamatsu University Hospital

Division name

2nd department of surgery

Zip code

Address

1-20-1 Handayama Higashi-ku Hamamatsu City Shizuoka prif. Japan 431-3192

TEL

053-435-2279

Homepage URL

Email

kamikin@hama-med.ac.jp

Institute

Hamamatsu University School of Medicine

Institute

Department

Personal name

Organization

Hamamatsu University School of Medicine

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

Date of disclosure of the study information

2016

Year

07

Month

25

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

Open public recruiting

Date of protocol fixation

2016

Year

05

Month

23

Day

Date of IRB

Anticipated trial start date

2016

Year

09

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

2016

Year

07

Month

20

Day

Last modified on

2017

Year

09

Month

22

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026806