UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011930
Receipt number R000013650
Scientific Title Multicentral phase II study which verifies the completion rate of adjuvant S-1 chemotherapy in elderly patients with gastric cancer.
Date of disclosure of the study information 2013/11/01
Last modified on 2013/10/01 16:20:18

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Basic information

Public title

Multicentral phase II study which verifies the completion rate of adjuvant S-1 chemotherapy in elderly patients with gastric cancer.

Acronym

SISCO-GC 01

Scientific Title

Multicentral phase II study which verifies the completion rate of adjuvant S-1 chemotherapy in elderly patients with gastric cancer.

Scientific Title:Acronym

SISCO-GC 01

Region

Japan


Condition

Condition

Gastric cancer

Classification by specialty

Gastroenterology Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the feasibility of adjuvant S-1 chemotherapy in alderly patients with stageII/III gastric cancer.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

Feasibility (Treatment completion rate)

Key secondary outcomes

OS, RFS, Safety


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

To find out the safety and efficacy of the anti-cancer drug for elderly patients with gastric cancer

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

75 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1)Histopathologically confirmed gastric cancer.
2)Curability A (R0).
3)Stage II (excluded T3N0) / III (Japanese classification).
4)No hepatic, peritoneal, or distant metastasis; no tumor cells in peritoneal fluid on cytologic analysis.
5)age:75.
6)No previous treatment(radiation therapy, chemotherapy, hormone therapy) for cancer except for the initial gastric resection for the primary lesion.
7)Oral administration is possible within 12 weeks after gastric resection.
8)Without any other severe diseases and adequate organ functions.
Leu: >=4,000 /mm3, <=ULN
Plt: >= 100,000 /mm3
T-bil: <= 1.5 g/dL
ALT<=ULNx2.5
AST<=ULNx2.5
Ccr: >= 30 mg/min
9)With written informed consent.

Key exclusion criteria

1)Active double cancer and/or past history of other cancer.
2)Flucytosin, phenytoin, or warfarin potassium administration.
3)Allergic more than and equal to grade3.
4)Patients with significant complications.
5)History of serious allergic reaction with S-1.
6)Men who have willing to become partner's pregnant.
7)Patients with HIV,HBV.
8)Not appropriate for the study at the physician's assessment.

Target sample size

65


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masahide Ikeguchi

Organization

Tottori University

Division name

Divsion of Surgical Oncology

Zip code


Address

36-1 nishi-cho, Yonago, 683-8504, Japan

TEL

0859-38-6567

Email

masaike@med.tottori-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hiroaki Saito

Organization

Tottori University

Division name

Divsion of Surgical Oncology

Zip code


Address

36-1 nishi-cho, Yonago, 683-8504, Japan

TEL

0859-38-6567

Homepage URL


Email

sai10@med.tottori-u.ac.jp


Sponsor or person

Institute

Tottori University, Divsion of Surgical Oncology

Institute

Department

Personal name



Funding Source

Organization

non

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

鳥取市立病院(鳥取県)、鳥取生協病院(鳥取県)、西伯病院(鳥取県)、島根大学医学部附属病院(島根県)、
公立八鹿病院(兵庫県)、鳥取大学医学部附属病院(鳥取県)、鳥取県立中央病院(鳥取県)、島根県立中央病院(島根県)、鳥取赤十字病院(鳥取県)、松江赤十字病院(島根県)、山陰労災病院(鳥取県)、米子医療センター(鳥取県)、鳥取県立厚生病院(鳥取県)、浜田医療センター(島根県)、益田地域医療センター医師会病院(島根県)、益田赤十字病院(島根県)、松江生協病院(島根県)、松江市立病院(島根県)、日野病院(鳥取県)、済生会江津総合病院(島根県)、公立雲南総合病院(島根県)、出雲市立総合医療センター島根県)、医療法人十字会野島病院(鳥取県)、医療法人同愛会博愛病院(鳥取県)


Other administrative information

Date of disclosure of the study information

2013 Year 11 Month 01 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

Open public recruiting

Date of protocol fixation

2010 Year 04 Month 09 Day

Date of IRB


Anticipated trial start date

2010 Year 08 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 10 Month 01 Day

Last modified on

2013 Year 10 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013650


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name