UMIN-CTR Clinical Trial

Public title

Phase I/II trial of preoperative TS-1 + CDDP + radiation therapy for large type 3 or type 4 advanced gastric cancer (OGSG 1205)

Acronym

Phase I/II trial of preoperative TS-1 +CDDP+radiation therapy for large type 3 or type 4 gastric cancer (OGSG 1205)

Scientific Title

Phase I/II trial of preoperative TS-1 + CDDP + radiation therapy for large type 3 or type 4 advanced gastric cancer (OGSG 1205)

Scientific Title:Acronym

Phase I/II trial of preoperative TS-1 +CDDP+radiation therapy for large type 3 or type 4 gastric cancer (OGSG 1205)

Region

Japan

Condition

Resectable large type 3 or type 4 Gastric Cancer

Classification by specialty

Gastroenterology	Gastrointestinal surgery	Radiology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate the safety and efficacy of TS-1+CDDP+radiation therapy for large type 3 or type 4 gastric cancer

Phase I : To evaluate the safety and to estimate the recommend dose and schedule of this regimen
Phase II : To evaluate the safety and efficacy in recommend dose

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Phase I,II

Primary outcomes

Phase I : Feasibility of the regimen followed by decision of recommend dose

Phase II : histological response rate of grade 3

Key secondary outcomes

Phase I : histological response rate of grade 3
Phase II : Response Rate, RFS, OS, completion rate of surgical operation, completion rate of curative resection, completion rate of hole regimen, incidence of down staging, incidence of surgical
complications and the grade, and incidence of adverse events and the grade

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

Drug: TS-1, CDDP, and radiation
[Level 0]
TS-1: 60mg/m2 po between day 1 and day 14
CDDP: 60mg/m2 iv on day 1
Radiation:2Gyx5/week X 4
[Level 1]
TS-1: 80mg/m2 po between day 1 and day 14
CDDP: 60mg/m2 iv on day 1
Radiation: 2Gyx5/week X 4
[Level 2]
TS-1: 80mg/m2 po between day 1 and day 14 followed by 1 week rest (one course). Two courses will be done.
CDDP: 60mg/m2 iv on day 1 and day 22
Radiation: 2Gyx5/week X 4

*Surgical operation will be done in 42 days after completion of radiation therapy

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

75

years-old

>=

Gender

Male and Female

Key inclusion criteria

1)Histologically confirmed gastric adenocarcinoma
2)Type 3 or Type 4 gastric cancer
3)The size of type 3 cancer is larger than 8cm
by CT
4)No peritoneal metastases and CY0 by diagnostic laparoscopy
5)Patient expected R0 resection at the registration
6)Esophageal invasion is smaller than 1cm
and no duodenal invasion
7)Age between 20 and 75 years old
8)Performance status (ECOG scale) 0 or 1
9)Without any prior chemotherapy and/or surgical treatment
10)Without bleeding from stomach lesion or stenosis on bowel
11)Adequate baseline organ and marrow function from data within 14 days before registration
a.WBC : >=4.000/mm3 and <12,000/mm3
b.Absolute neutrophil count : >=2,000 / mm3
c.Platelets : >=100,000 / mm3
d.Hemoglobin : >=9.0 g/dL
e.AST (SGOT)/ALT (SGPT) : <100 IU/L
f.Total bilirubin : <2.0mg/dL
g.Creatine clearance : >=60mL/min
*Cockcrft-Gault method is available
12)Patients who can take food orally
13)Patients should sign a written informed consent

Key exclusion criteria

1)with active double cancer within 5 years except intramucosal cancer
2)with a history of severe allergy
3)with active infectious disease(over 38 degrees C)
4)Women in pregnancy, at risk of pregnancy, or hoping to become pregnant.
5)Men who want their partners to become
pregnant
6)with a history of cardiac infarction in recent 6 months
7) with a continuous administration of steroids
8)patient who needs continuous administration of
Flucytosine, fenitoin or walfarin karium
9)with ulceration on digestive tract and/or
bleeding from the ulcer
10)with uncontrollable diarrhea or watery stool
11) with active hepatitis B Ag and/or hepatitis C Ab
12) with serious complication as followings,
-Interstitial pneumonia
-Pulmonary fibrosis
-paralysis on bowel
-ischemic heart diseases
13)Any patients judged by the investigator to be
unfit to participate in the study

Target sample size

30

Name of lead principal investigator

1st name
Middle name
Last name	Hiroshi Furukawa

Organization

Kinki University School of Medicine

Division name

Department of Surgery

Zip code

Address

77-2, Ohnohigashi , Osakasayama, Osaka, 589-8511, Japan

TEL

072-366-0221

Email

hiroshi.furukawa@tokushukai.jp

Name of contact person

1st name
Middle name
Last name	Motohiro Imano

Organization

Kinki University School of Medicine

Division name

Department of Surgery

Zip code

Address

77-2, Ohnohigashi , Osakasayama, Osaka, 589-8511, Japan

TEL

072-366-0221

Homepage URL

Email

imano-m@surg.med.kindai.ac.jp

Institute

Osaka Gastrointestinal cancer chemotherapy Study Group (OGSG)

Institute

Department

Personal name

Organization

Osaka Clinical Study Supporting Organization

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

OGSG参加施設
近畿大学医学部 外科(大阪府)、市立東大阪医療センター(大阪府)、大阪医科大学(大阪府)

Date of disclosure of the study information

2012

Year

09

Month

23

Day

URL releasing protocol

https://academic.oup.com/jjco/article/43/4/431/974739

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

20

Results

Results date posted

Results Delayed

Delay expected

Results Delay Reason

manuscript in preparation

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

Completed

Date of protocol fixation

2012

Year

09

Month

10

Day

Date of IRB

2012

Year

10

Month

25

Day

Anticipated trial start date

2012

Year

11

Month

07

Day

Last follow-up date

2019

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

2019

Year

01

Month

28

Day

Other related information

Registered date

2012

Year

09

Month

23

Day

Last modified on

2020

Year

04

Month

05

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010513