UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013821 |
|---|---|
| Receipt number | 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 22:26:19 |
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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
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
imano@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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016070
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