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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000025824
Receipt No. 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 2017/01/24

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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
Middle name
Last name Tsutomu Namikawa
Organization Kochi Medical School
Division name Department of Surgery
Zip code
Address Kohasu, Oko-cho, Nankoku, Kochi 783-8505, Japan
TEL +81-88-880-2370
Email tsutomun@kochi-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tsutomu Namikawa
Organization Kochi Medical School
Division name Department of Surgery
Zip code
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
Email tsutomun@kochi-u.ac.jp

Sponsor
Institute Department of Surgery, Kochi Medical School
Institute
Department

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
Address
Tel
Email

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 Preinitiation
Date of protocol fixation
2017 Year 01 Month 22 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 30 Day
Last follow-up date
2019 Year 01 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
2017 Year 01 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029656

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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