UMIN-CTR Clinical Trial

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000004701
Receipt No. 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 (Ver. 13)

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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
Last 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
Email ysakai@kuhp.kyoto-u.ac.jp

Public contact
1st 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
Email hokabe@kuhp.kyoto-u.ac.jp

Sponsor
Institute Department of Surgery
Graduate School of Medicine, Kyoto University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005596