UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004701 |
|---|---|
| Receipt number | R000005596 |
| Scientific Title | A randomized phase II trial of adjuvant therapy with S-1 plus Hotyu-ekki-to (TJ41) versus S-1 alone for stage II/III gastric cancer |
| Date of disclosure of the study information | 2011/02/01 |
| Last modified on | 2019/04/20 21:46:14 |
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Basic information
Public title
A randomized phase II trial of adjuvant therapy with S-1 plus Hotyu-ekki-to (TJ41) versus S-1 alone for stage II/III gastric cancer
Acronym
A randomized phase II trial of adjuvant therapy with S-1 plus Hotyu-ekki-to (TJ41) versus S-1 alone for stage II/III gastric cancer (KUGC07)
Scientific Title
A randomized phase II trial of adjuvant therapy with S-1 plus Hotyu-ekki-to (TJ41) versus S-1 alone for stage II/III gastric cancer
Scientific Title:Acronym
A randomized phase II trial of adjuvant therapy with S-1 plus Hotyu-ekki-to (TJ41) versus S-1 alone for stage II/III gastric cancer (KUGC07)
Region
| Japan |
Condition
Condition
Stage II or III gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate alleviative effects of Hotyu-ekki-to on adjuvant chemotherapy with S-1 for stage II or III gastric cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
completion rate of one year adjuvant treatment with S-1
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
S-1:80mg/m2 PO bid (morning and evening) for 4 weeks with 2 weeks rest
For one year after surgery
Interventions/Control_2
S-1:80mg/m2 PO bid (morning and evening) for 4 weeks with 2 weeks rest,
Hotyu-ekki-to:7.5g/day (2.5gx3) PO everyday
For one year after surgery
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
(1)Histologically proven gastric cancer
(2) pStage II/III (except for T3N0 tumor) after R0 resection
(3) Patient with negative peritoneal washing cytology, and without liver metastasis
(4) Age 20-80 years old
(5) Patient who can start S-1 within 8 weeks after surgery.
(6)Adequate organ functions defined as indicated below
(i)WBC >= 3,000 /mm3 , WBC <= 12,000 /mm3
(ii)neutrophil >= 1,500 /mm3
(iii)hemoglobin >=9 g/dL
(iv)Plt >= 100,000 /mm3
(v) T.Bil <= 1.5 mg/dL
(vi) AST(GOT) , ALT(GPT) <= 100 IU/L
(vii) Ccr >= 60 mL/min
(7) Written informed consent
Key exclusion criteria
(1)Patient with active double cancer (synchronous double cancer and metachronous double cancer), excluding carcinoma in situ (lesions equal to intraepithelial or intramucosal cancer) judged to have been cured with local treatment.
(2)Patient who was diagnosed as cStage IV at any time during preoperative treatment
(3)Patient with administration contraindication of S-1
(4)Patient with regular use of H2-blocker, proton pump inhibitor, flucytosine, phenytoin, or warfarin.(5)Patients with past history of severe allergic reactions.
(6)Patient with severe complications, such as paralytic ileus, bowel obstruction, interstitial pneumonitis, pulmonary fibrosis, or uncontrollable diabetes mellitus, heart failure, renal failure, or liver cirrhosis
(7)Severe watery diarrhea.
(8)Pregnant or nursing patient or with intent to bear baby
(9) Men with partner willing to get pregnant
(10)Exclude patients who are recognized as inadequate patients by doctors with responsibility in this trial.
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | Yoshiharu |
| Middle name | |
| Last name | Sakai |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Surgery
Zip code
6068507
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, JAPAN
TEL
075-366-7595
ysakai@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Okabe |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Surgery
Zip code
6068507
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, JAPAN
TEL
075-366-7595
Homepage URL
hokabe@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Surgery
Graduate School of Medicine, Kyoto University
Institute
Department
Personal name
Funding Source
Organization
None
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
Kyoto University Ethics comittiee
Address
54 Shogoin Kawaharacho, sakyo-ku, Kyoto
Tel
075-753-4680
ethcom@kuhp.kyoto-u.ac.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
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 02 | Month | 01 | Day |
Related information
URL releasing protocol
https://www.frontiersin.org/articles/10.3389/fonc.2019.00294/full?&utm_source=Email_to_authors_&utm_
Publication of results
Published
Result
URL related to results and publications
https://www.frontiersin.org/articles/10.3389/fonc.2019.00294/full?&utm_source=Email_to_authors_&utm_
Number of participants that the trial has enrolled
113
Results
Results: We randomly assigned 56 patients to group ST and 57 patients to group S.
The completion rates of S-1 were 54.5 and 50.9%, the median relative dose intensities
were 89.2 and 71.9%, and adverse events of grade 3 or 4 occurred in 45.5 and 54.5%
in groups ST and S, respectively. There was no significant difference in 3-year OS or RFS
between the two groups.
Results date posted
| 2019 | Year | 04 | Month | 20 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2019 | Year | 04 | Month | 17 | Day |
Baseline Characteristics
Characteristic S-1 plus TJ-41 S-1 only P*
(N = 55) (N = 55)
Sex 1.000
Male 37 (67.3) 37 (67.3)
Female 18 (32.7) 18 (32.7)
Age (median, range) 65, 49 to 76 64, 35 to 77 0.322
Neoadjuvant Chemotherapy 0.185
No 48 (87.3) 52 (94.5)
Yes 7 (12.7) 3 (5.5)
Type of Surgery 0.699
Distal/proximal gastrectomy 33 (60.0) 31 (58.4)
Total gastrectomy 22 (40.0) 24 (43.6)
T Category 0.088
T1 3 (5.5) 1 (1.8)
T2 9 (16.4) 16 (29.1)
T3 13 (23.6) 19 (34.5)
T4 30 (54.6) 19 (34.5)
N Category 0.281
N0 8 (14.5) 6 (10.9)
N1 13 (23.6) 19 (34.5)
N2 13 (23.6) 17 (30.9)
N3 21 (38.2) 13 (23.6)
Stage 0.561
II 21 (38.2) 24 (43.6)
III 34 (61.8) 31 (56.4)
Participant flow
We randomly assigned 56 patients to group ST and 57 patients to group S.
Adverse events
Adverse events of grade 3 or 4 occurred in 45.5 and 54.5% in TJ-41 and control group.
Outcome measures
The completion rates of S-1 were 54.5 and 50.9%,in TJ-41 and control group.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2010 | Year | 12 | Month | 07 | Day |
Date of IRB
| 2011 | Year | 01 | Month | 18 | Day |
Anticipated trial start date
| 2011 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 12 | Month | 10 | Day |
Last modified on
| 2019 | Year | 04 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005596
