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

Email

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

Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name