UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030482
Receipt number R000034802
Scientific Title Combination chemotherapy of TS-1, oxaliplatin and irinotecan (TIROX) for unresectable gastric cancer; a phase I study
Date of disclosure of the study information 2017/12/20
Last modified on 2020/12/21 09:32:27

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Combination chemotherapy of TS-1, oxaliplatin and irinotecan (TIROX) for unresectable gastric cancer; a phase I study

Acronym

TIROX for unresectable gastric cancer

Scientific Title

Combination chemotherapy of TS-1, oxaliplatin and irinotecan (TIROX) for unresectable gastric cancer; a phase I study

Scientific Title:Acronym

TIROX for unresectable gastric cancer

Region

Japan


Condition

Condition

gastric cancer

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to determine the maximum-tolerated dose and recommended dose

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Phase I


Assessment

Primary outcomes

MTD, RD

Key secondary outcomes

Response rate, Incidence and extent of adverse events, Time to treatment failure, Progressin free survival, Overall survival


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

TS-1 fixed dose
L-OHP fixed dose
CPT-11 dose escalation

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

75 years-old >=

Gender

Male and Female

Key inclusion criteria

"(1) Histological proven adenocarcinoma
(2) unresectable gastric cancer
(3) HER2 untested or negative
(4) PS 0-1
(5) No history of chemotherapy or radiotherapy for unresectable gastric cancer
(6) No massive ascites or massive pleural effusion retention
(7) Patients without brain metastasis
(8) Adequate organ function
(9) Possible oral intake
(10) Expected life span is more than 3 months
(11) Written informed consent from patients
"

Key exclusion criteria

"(1) Synchronous or metachronous (within 5 years) malignancies except for carcinoma in situ or mucosal tumors curatively treated with local therapy.
(2) Recurrence after surgery
(3) Past history of severe hypersensitivity to drugs
(4) Diarrhea (4 or more times per day or watery diarrhea)
(5) Body temperature of over 38 degrees Celsius or active infection
(6) serious bone marrow suppression, a renal damage or a liver damage
(7) Severe complications
(8) Positive HBs antigen
(9) Under treatment with flucytosine or atazanavir
(10) Under treatment with phenytoin or warfarin
(11) Continuous systemic steroid therapy
(12) Pregnant women, women with the possibility of the pregnancy, or men who want their partners to become pregnant
(13) Psychological disorder
(14) Patients judged inappropriate for the study by the physicians
"

Target sample size

18


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masahiro Gotou

Organization

Osaka Medical College Hospital

Division name

Chemotherapy Center

Zip code


Address

2-7 Daigaku-machi, Takatsuki City, Osaka, Japan

TEL

0726-683-1221

Email

in2030@osaka-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tetsuji Terasawa

Organization

Osaka Medical College Hospital

Division name

Chemotherapy Center

Zip code


Address

2-7 Daigaku-machi, Takatsuki City, Osaka, Japan

TEL

072-683-1211

Homepage URL


Email

terasawat@osaka-med.ac.jp


Sponsor or person

Institute

Osaka Medical College Hospital

Institute

Department

Personal name



Funding Source

Organization

Osaka Medical College Hospital

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


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 12 Month 20 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 11 Month 13 Day

Date of IRB

2017 Year 11 Month 13 Day

Anticipated trial start date

2017 Year 11 Month 13 Day

Last follow-up date

2020 Year 11 Month 12 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 12 Month 20 Day

Last modified on

2020 Year 12 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034802


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name