UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025824 |
|---|---|
| Receipt number | R000029656 |
| Scientific Title | Treatment using Oxaliplatin and S-1 Adjuvant chemotherapy for Stage III gastric cancer trial |
| Date of disclosure of the study information | 2017/01/30 |
| Last modified on | 2023/07/30 10:21:29 |
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Basic information
Public title
Treatment using Oxaliplatin and S-1 Adjuvant chemotherapy for Stage III gastric cancer trial
Acronym
TOSA trial
Scientific Title
Treatment using Oxaliplatin and S-1 Adjuvant chemotherapy for Stage III gastric cancer trial
Scientific Title:Acronym
TOSA trial
Region
| Japan |
Condition
Condition
Gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy and safety of adjuvant chemotherapy using S-1 + Oxaliplatin for Stage III gastric cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Three-year Relapse-Free Survival
Key secondary outcomes
Overall Survival
Incidence of Adverse events
Grading of neuropathy in each treatment cycle
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
S-1 was given orally twice daily for the first 2 weeks of a 3-week cycle. The dosage was 80 mg/day for body surface area (BSA) less than 1.25 m2, 100 mg/day for BSA ranging from 1.25 m2 to less than 1.5 m2, and 120 mg/day for BSA of 1.5 m2 or greater. On day 1 of second 21-day cycle, patients received 100 mg/m2 of Oxaliplatin followed by 80 mg/m2 of S-1 (maximum 8 cycles). Then, the patients received 80 mg/m2 of S-1 per day, for 4 weeks, followed by 2 weeks of no chemotherapy. This 6-week
cycle was repeated during the first year after surgery.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Histologically proven, Stage III resectable gastric adenocarcinoma.
2. D2 or more extensive lymph-node dissection with R0 surgery (with the result of no residual tumor)
3. No hepatic, peritoneal, or distant
metastasis; no tumor cells in peritoneal fluid on cytologic analysis.
4. An age of 20 years and over.
5. A performance status of 0-1 according to the Eastern Cooperative Oncology Group
(ECOG) scale.
6. Patients who recived surgery during the previous 6 weeks, being possible peroral administration.
7. No previous treatment for cancer except for the initial gastric resection for the primary lesion.
8. Adequate organ function during the previous 14 days.
9. All patients gave written informed consent.
Key exclusion criteria
1. Synchronous or metachronous malignant disease, or multicentric cancer.
2. Serious postoperative morbidity such as serious infection, anastomotic leakage, gastrointestinal bleeding and so on.
3. Serious concurrent disease such as intestinal palsy, small bowel obstraction, interstitial pneumonia, pulmonary fibrosis, uncontrolable diabetes mellitus, heart failure, renal failure, liver cirrhosis, hepatic failure, and so on.
4. Active infectious disease.
5. Positive of HBs antigen or HCV antibody.
6. Continuous treatment with steroids.
7. Serious diarrhea.
8. A medical history of serious allergy to any drug.
9. Ascites beyond the pelvic cavity or
pleural effusion.
10. Brain metastasis.
11. Taking flucytosine or phenytoin.
12. Needs of taking warfarin potassium.
13. Sensory neuropathy caused by any drug.
14. A history of blood transfusion or administration of granulocyte-colony stimulating factor within 3 weeks before enrollment.
15. Women who are pregnant or hope to become pregnant during the study period.
16. Patients judged inappropriate for the study by their physicians.
Target sample size
75
Research contact person
Name of lead principal investigator
| 1st name | Tsutomu |
| Middle name | |
| Last name | Namikawa |
Organization
Kochi Medical School
Division name
Department of Surgery
Zip code
783-8505
Address
Kohasu, Oko-cho, Nankoku, Kochi 783-8505, Japan
TEL
+81-88-880-2370
tsutomun@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | Tsutomu |
| Middle name | |
| Last name | Namikawa |
Organization
Kochi Medical School
Division name
Department of Surgery
Zip code
783-8505
Address
Kohasu, Oko-cho, Nankoku, Kochi 783-8505, Japan
TEL
+81-88-880-2370
Homepage URL
http://www.kochi-ms.ac.jp/~fm_srgr1/index.html
tsutomun@kochi-u.ac.jp
Sponsor or person
Institute
Department of Surgery, Kochi Medical School
Institute
Department
Personal name
Funding Source
Organization
Department of Surgery, Kochi Medical School
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kochi Medical School
Address
Kohasu, Oko-cho, Nankoku, Kochi 783-8505, Japan
Tel
088-880-2370
tsutomun@kochi-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
| 2017 | Year | 01 | Month | 30 | 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
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
| 2017 | Year | 01 | Month | 22 | Day |
Date of IRB
| 2017 | Year | 01 | Month | 16 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 30 | Day |
Last follow-up date
| 2023 | Year | 07 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 01 | Month | 24 | Day |
Last modified on
| 2023 | Year | 07 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029656
