UMIN-CTR Clinical Trial

Public title

Feasibility study of adjuvant chemotherapy with TS-1 followed by DCS (DTX+CDDP+S-1) for stage III gastric cancer

Acronym

Feasibility study of adjuvant chemotherapy with TS-1 followed by DCS (DTX+CDDP+S-1) for stage III gastric cancer

Scientific Title

Feasibility study of adjuvant chemotherapy with TS-1 followed by DCS (DTX+CDDP+S-1) for stage III gastric cancer

Scientific Title:Acronym

Feasibility study of adjuvant chemotherapy with TS-1 followed by DCS (DTX+CDDP+S-1) for stage III gastric cancer

Region

Japan

Condition

Gastric Cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate the completion rate , efficacy and safety of adjuvant chemotherapy with TS-1 followed by DCS (DTX+CDDP+S-1) for StageIII gastric cancer

Basic objectives2

Others

Basic objectives -Others

completion rate

Trial characteristics_1

Confirmatory

Trial characteristics_2

Developmental phase

Phase II

Primary outcomes

Treatment completion rate after 2 cycle of S-1, DTX plus CDDP

Key secondary outcomes

Overall Survival, Relapse Free Survival, Completion rate of S-1 for 1year, Safety

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

1st course (S-1 alone): S-1 80mg/m2 d1-14, q3w
Treatment consisted of 2nd and 3rd courses of S-1 (80 mg/m2/day, b.i.d.) for 14 days followed by a 7-day rest. Docetaxel (35 mg/m2 iv) and Cisplatin (35 mg/m2 iv) on day 1 and 15, q4w.

After 3rd course, S-1 alone e is given until 1 year post surgery.

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) Histopathologically proven gastric cancer
(2) D2 lymph-node dissection woti R0 surgery
(3) Patients with StageIIIA, StageIIIB or StageIIIC gastric cancer
(4) No previous treatment (chemotherapy, radootherapy) for any cancer
(5) ECOG performance status 0 or 1.
(6) 20 years of age and older
(7) Patients who can take medecine orally
(8) Without any other severe diseases
WBC: 3,500 - 12,000 /mm3
ANC: > 2,000 /mm3
Hgb: > 9.0 g/dL
Platelets: > 100,000 /mm3
total bilirubin: < 1.5xULN
Total bilirubin: < 1.5xULN
AST and ALT: < 2.5xULN
Creatinine: < 1.2 mg/dL
(9)Written informed consent

Key exclusion criteria

(1) Synchronous or metachronous (within 5 years) malignancies other than carcinoma in situ or mucosal carcinoma, and multicentric cancer.
(2) Patients who are contraindicated to S-1, CDDP, and DTX.
(3) Patient is taking flucytosine and phenytoin.
(4) Patients with the history of severe drug hypersensitivity.
(5) Patients with severe complication (intestinal paralysis, intestinal obstruction, interstitial pneumonitis, pulmonary fibrosis, severe diabetes, heart failure, renal failure, liver cirrhosis, liver failure, etc.).
(6) Patients with diarrheal disease or watery diarrhea.
(7) Pregnant and/or nursing women
(8) Patients with positive HBs antigen
(9) Any subject judged by the investigator to be unfit for any reason to participate in the study.

Target sample size

30

Name of lead principal investigator

1st name
Middle name
Last name	Noriyuki Hirahara, M.D., Ph.D.

Organization

Shimane University Hospital

Division name

Digestive and General Surgery

Zip code

Address

89-1, Enya-cho, Izumo, Shimane, 693-8501, Japan

TEL

0853-20-2232

Email

norinori@med.shimane-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Noriyuki Hirahara, M.D., Ph.D.

Organization

Shimane University Hospital

Division name

Digestive and General Surgery

Zip code

Address

89-1, Enya-cho, Izumo, Shimane, 693-8501, Japan

TEL

0853-20-2232

Homepage URL

Email

norinori@med.shimane-u.ac.jp

Institute

Shimane University Hospital

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

Date of disclosure of the study information

2014

Year

01

Month

08

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

2013

Year

03

Month

01

Day

Date of IRB

Anticipated trial start date

2013

Year

06

Month

24

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2014

Year

01

Month

08

Day

Last modified on

2014

Year

01

Month

08

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014936