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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008964
Receipt No. R000010513
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)
Date of disclosure of the study information 2012/09/23
Last modified on 2020/04/05

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Basic information
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
Condition Resectable large type 3 or type 4 Gastric Cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
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

Assessment
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

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 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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute Osaka Gastrointestinal cancer chemotherapy Study Group (OGSG)
Institute
Department

Funding Source
Organization Osaka Clinical Study Supporting Organization
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 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)

Other administrative information
Date of disclosure of the study information
2012 Year 09 Month 23 Day

Related information
URL releasing protocol https://academic.oup.com/jjco/article/43/4/431/974739
Publication of results Unpublished

Result
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

Progress
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
Other related information

Management information
Registered date
2012 Year 09 Month 23 Day
Last modified on
2020 Year 04 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010513

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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