UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011438 |
|---|---|
| Receipt number | R000013104 |
| Scientific Title | Exploratory Research on Prognosis Factors and Risk-factors of Adverse Drug Reactions in the Adjuvant Chemotherapy with S-1 for Patients with Curatively Resected Gastric Cancer |
| Date of disclosure of the study information | 2013/08/12 |
| Last modified on | 2020/07/21 10:14:10 |
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Basic information
Public title
Exploratory Research on Prognosis Factors and Risk-factors of Adverse Drug Reactions in the Adjuvant Chemotherapy with S-1 for Patients with Curatively Resected Gastric Cancer
Acronym
JACCRO GC-07 AR
Scientific Title
Exploratory Research on Prognosis Factors and Risk-factors of Adverse Drug Reactions in the Adjuvant Chemotherapy with S-1 for Patients with Curatively Resected Gastric Cancer
Scientific Title:Acronym
JACCRO GC-07 AR
Region
| Japan |
Condition
Condition
Gastric Cancer
Classification by specialty
| Gastroenterology | Hematology and clinical oncology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the following items using the background factors such as clinical examination before start of administration and dosage form in the patients registered on JACCRO GC-07 study. 1. Predicting prognosis factors in the adjuvant therapies containing S-1 2. Risk-factors of adverse drug reactions in the adjuvant therapies containing S-1 3. Factors affecting the continuities of drug administration in the adjuvant therapies containing S-1
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Correlations between the following items A and B
A:
1. 3-year and 5-year relapse-free survival
2. 3-year and 5-year overall survival
3. time to treatment failure
4. side-effects
5. continuity of S-1 administration
B:
1. 1) clinical examination: WBC, ANC, Lymphocite, PLF, Hb, bilirubin, AST, ALT, ALP, albumin, CRP, eGFR, creatinine, CCR, 2) Age,3) Sex, 4) Height, 5) Weight, 6) Surgical method, type of surgery, type of re-constraction, 7) number of resected lymphnodes, number of metastatic lymphnodes,8) Stage, 9) Histological classification, 10) lymphatic invasion, vein invasion, 11) tumor markers, 12) PS, 13) medication status and dosage of S-1, 14) medication status of docetaxel.
2. Prognostic nutritional index
3. Glasgow prognostic score
4. Neutrophili/lymphocite ratio
5. body weight loss
6. body mass index
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Among the patients who were registered in JACCRO GC-07 (UMIN000010337), those who meet the following criteria.
1. following items within 14 days before surgery were obtained
1) WBC, ANC, Lymphocyte, ALP, Albumin, CRP
2) Weight
2. CEA and CA19-9 within 28 days before surgery were obtained
3. Written informed Consent
Key exclusion criteria
1. Patients who are judged as inadequate for study enrollment by investigators
Target sample size
880
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Sano |
Organization
Cancer Institute Hospital
Division name
Department of Digestive Surgery
Zip code
135-8550
Address
3-8-31 Ariake, Koto-ku, Tokyo, Japan
TEL
03-3520-0111
takeshi.sano@jfcr.or.jp
Public contact
Name of contact person
| 1st name | Masashi |
| Middle name | |
| Last name | Fujii |
Organization
Nonprofit Organization Japan Clinical Cancer Research Organization
Division name
Office
Zip code
104-0061
Address
1-14-5 Ginza, Chuo-ku, Tokyo 104-0061, Japan
TEL
03-5579-9882
Homepage URL
gc07.dc@jaccro.or.jp
Sponsor or person
Institute
Nonprofit Organization Japan Clinical Cancer Research Organization
Institute
Department
Personal name
Funding Source
Organization
TAIHO PHARMACEUTICAL CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japan Clinical Cancer Research Organization Institutional Review Board
Address
7F Ginza Wing Bil., 1-14-5 Ginza, Chuo-ku, Tokyo 104-0061, Japan
Tel
03-5579-9882
jaccro@jaccro.or.jp
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
がん研有明病院（東京都）ほか、JACCRO参加施設
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 08 | Month | 12 | 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
609
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
No longer recruiting
Date of protocol fixation
| 2013 | Year | 06 | Month | 11 | Day |
Date of IRB
| 2013 | Year | 06 | Month | 11 | Day |
Anticipated trial start date
| 2013 | Year | 07 | Month | 17 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 02 | Month | 28 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 06 | Month | 30 | Day |
Other
Other related information
Exploratory Research on Prognosis Factors and Risk-factors of Adverse Drug Reactions in the Adjuvant Chemotherapy with S-1 for Patients with Curatively Resected Gastric Cancer
Prospective Study
Management information
Registered date
| 2013 | Year | 08 | Month | 10 | Day |
Last modified on
| 2020 | Year | 07 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013104
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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