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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013821
Receipt No. R000016070
Scientific Title A phase I/II study of preoperative TS-1 combined chemoradiation therapy for patients with large type 3 or type 4 gastric cancer (OGSG 1303)
Date of disclosure of the study information 2014/04/28
Last modified on 2020/01/22

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Basic information
Public title A phase I/II study of preoperative TS-1 combined chemoradiation therapy for patients with large type 3 or type 4 gastric cancer (OGSG 1303)
Acronym A phase I/II study of preoperative TS-1 combined chemoradiation therapy for patients with large type 3 or type 4 gastric cancer (OGSG 1303)
Scientific Title A phase I/II study of preoperative TS-1 combined chemoradiation therapy for patients with large type 3 or type 4 gastric cancer (OGSG 1303)
Scientific Title:Acronym A phase I/II study of preoperative TS-1 combined chemoradiation therapy for patients with large type 3 or type 4 gastric cancer (OGSG 1303)
Region
Japan

Condition
Condition gastric cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To confirm the efficacy and safety of preoperative TS-1 combined chemo-
radiation therapy for patients with large type 3 or type 4 gastric cancer expected curative resection
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Phase I:rate of dose limiting toxicty
Phase II:Response Rate (RR)
Key secondary outcomes Phase I:Response Rate (RR), Safety(frequency of adverse events, ncidence of a postoperative complication)
Phase II:Overall Survival Rate(OS), Progression Free Survival Rate(PFS), Time To Failure(TTF), Disease Control Rate (DCR), Incidence and Grade of Adverse Events, Relative Performance, Rate of Patients who receive next treatment

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 1) Treatment period for chemoradiation is 28 days on level 0 or level 1, and 35 days on level 2.
2) TS-1 is administered twice a day (morning and evening).
On level 0, 60 mg/m2/day of TS-1 is to be administered for 14 days Day 1 to day 14) and to be rest following 14 days.
On level 1, 80 mg/m2/day of TS-1 is to be administered for 14 days and to be rest following 14 days.
On level 2, 80 mg/m2/day of TS-1 is to be administered for 14 days and after 7 days rest, additional 80 mg/m2/day of TS-1 is to be administered for 14 days (day 22 to day 36).
3) Patients undergo a 2.0 Gy/day of radiation for 20 days (day 1 to day 5, day 8 to day 12, day 15 to day 19, and day 22 to day 26)
4) Patients undergo the surgical operation after the chemoradiation until
Day 82.
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
75 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)Age:older than 75 years old at the registration
2) histologically proven gastric carcinoma by endoscopic detection
3) patients with large type 3 or type 4 gastric cancer
Large:the size of cancer is larger than 8 cm
4) without peritoneal metastasis (P0) and negative in lavage cytology (CY0) by laparoscopic examination
5) expected curative resection (R0)
6) without esophageal invasion longer than 1.1 cm or duodenal invasion
7) An Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
8) without any prior chemotherapy, radiation therapy and/or surgical treatment
9) without any bleeding from main lesion or intestinal stenosis
10) with good functions of important organs
a) WBC: =>3000 and <12,000/mm3
b) Neutrophil: =>1,500/mm3
c) Hemoglobin: =>8.0 g/dl
d) Platelet: =>100,000/mm3
e) AST, ALT: =< 100 IU/L
f) T.bil.: =<1.5 mg/dL
g) creatinine clearance: =>40 ml/min
CC by Cockcroft-Gault method is available
When CC is between 40 and 59, TS-1 is to be one-level dose down.
11) Patients can take food orally
12) with written Informed Consent
13) without peritoneal adhesion
Key exclusion criteria 1) with active double cancers excluding carcinoma in situ and/or prior
cancer cured with longer than 5 year interval period
2) with a history of severe allergy against medicine
3) with infectious disease and febrile condition (over 38 centigrade)
4) pregnant or nursing female
5) male expecting pregnancy of partner
6) with a history of cardiac infarction within 6 months
7) under continuous steroids medication
8) Patients who are received systemic continuous administration of flucytosine, phenytoin or warfarin
9) bleeding from gastrointestinal tract
10) with uncontrollable diarrhea (watery stool and/or frequent diarrhea)
11) with HBs antigen+, and/or HCV-antibody+
12) with severe diseases: autoimmune diseases, intestinal paralysis, interstitial pneumonitis/pulmonary fibrosis, ischemic cardiac diseases
13) Any other patients whom the physician in charge of the study judges to be unsuitable
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Motohiro Imano
Organization Kindai University Faculty of Medicine
Division name Department of Surgely
Zip code
Address 77-2, Ohnohigashi , Osakasayama, Osaka, 589-8511, Japan
TEL 072-366-0221
Email imano@med.kindai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Motohiro Imano
Organization Kindai University Faculty of Medicine
Division name Department of Surgely
Zip code
Address 77-2, Ohnohigashi , Osakasayama, Osaka, 589-8511, Japan
TEL 072-366-0221
Homepage URL
Email imano@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 市立東大阪医療センター(大阪府)、近畿大学医学部(大阪府)、堺市立総合医療センター(大阪府)

Other administrative information
Date of disclosure of the study information
2014 Year 04 Month 28 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 10
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

Progress
Recruitment status Completed
Date of protocol fixation
2014 Year 03 Month 31 Day
Date of IRB
2014 Year 03 Month 01 Day
Anticipated trial start date
2014 Year 07 Month 04 Day
Last follow-up date
2021 Year 08 Month 06 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
2014 Year 04 Month 27 Day
Last modified on
2020 Year 01 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016070

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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