UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008964 |
|---|---|
| Receipt number | 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 | 2025/05/25 16:58:36 |
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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
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
imano-m@surg.med.kindai.ac.jp
Sponsor or person
Institute
Osaka Gastrointestinal cancer chemotherapy Study Group (OGSG)
Institute
Department
Personal name
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
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
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1245/s10434-024-16845-x
Number of participants that the trial has enrolled
20
Results
In total, 19 patients underwent the protocol surgery; 2 (10.5%) achieved a pathological complete response. There were no treatment-related deaths; 3- and 5-year overall survival rates were 70.0 and 50.0%, respectively.
Results date posted
| 2025 | Year | 05 | Month | 25 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2025 | Year | 01 | Month | 15 | Day |
Baseline Characteristics
Patient with +clinically resectable type 4 or large type 3 gastric cancer (GC)
Participant flow
A total of six patients were enrolled in the phase I study. In phase II, 20 patients were enrolled from November 2012 to April 2018.
Adverse events
Grade 3/4 leukopenia and nonhematologic adverse events occurred in 35% and 5% of the patients, respectively. There were no treatment-related deaths.
Outcome measures
3- and 5-year overall survival rates were 70.0 and 50.0%, respectively.
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
| 2025 | Year | 05 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010513
