UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009349
Receipt number R000010981
Scientific Title Multicenter phase II study of combination therapy with oral S-1 plus cisplatin in elderly patients with metastatic gastric cancer
Date of disclosure of the study information 2012/11/19
Last modified on 2017/05/22 19:08:25

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Basic information

Public title

Multicenter phase II study of combination therapy with oral S-1 plus cisplatin in elderly patients with metastatic gastric cancer

Acronym

Phase II of S-1 plus CDDP for elderly gastric cancer (SPEL)

Scientific Title

Multicenter phase II study of combination therapy with oral S-1 plus cisplatin in elderly patients with metastatic gastric cancer

Scientific Title:Acronym

Phase II of S-1 plus CDDP for elderly gastric cancer (SPEL)

Region

Japan


Condition

Condition

Elderly patients with metastatic gastric cancer

Classification by specialty

Hepato-biliary-pancreatic medicine Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy and safety of combination therapy with S-1 plus cisplatin in elderly patients with metastatic gastric cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

Overall survival

Key secondary outcomes

Response rate, progression-free survival, time to treatment failure, adverse events


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

5-week cycle of intravenous cisplatin (30-60 mg/m2 on day 8) and oral administration of S-1(25-60mg, twice a day, between days 1 and 21)

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

76 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1) Pathologically proven adenocarcinoma (papillary, tubular, or poorly differentiated), signet ring cell carcinoma, mucinous adenocarcinoma, or hepatoid adenocarcinoma
2) Unresectable advanced or recurrent disease
3) Age over 76 years
4) ECOG performance status (PS) of 0 or 1
5) No previous chemotherapy, or radiotherapy except post-operative adjuvant chemotherapy with fluoropyrimidine alone or fluoropyrimidine/leucovorin as long as it was completed at least 24 weeks prior to registration, or either hormone therapy as long as it was completed at least 24 weeks prior to registration
6) Adequate food intake
7) Negative HER2 status
8) Adequate organ function as defined below:
a) Neutrophil count >= 1,500 /mm3
b) Platelet count >= 100000 /mm3
c) Total bilirubin =< 1.5 mg/dL
d) AST =< 100 IU/L (<200 IU/L in patients with liver metastasis)
e) ALT =< 100 IU/L (<200 IU/L in patients with liver metastasis)
f) Serum creatinine =< 1.5 mg/dL and Ccr >= 30mL/min
9) Written informed consent

Key exclusion criteria

1) Synchronous or metachronous (within 5 years) malignancies other than carcinoma in situ or mucosal carcinoma
2) Body temperature >= 38C
3) Severe mental disease
4) Current treatment with systemic steroids
5) Uncontrolled diabetes mellitus
6) Unstable angina pectoris within the past 3 weeks, or previous myocardial infarction within the past 6 months
7) Evidence of any other serious disease; renal failure, hepatic failure, interstitial pneumonia, or pulmonary fibrosis
8) Active bleeding
9) Massive ascites
10) Massive pleural effusion
11) Judged ineligible by the clinical investigators

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tetsuya Hamaguchi

Organization

National Cancer Center Hospital

Division name

Gastrointestinal Oncology Division

Zip code


Address

5-1-1 Tsukiji, Chuo-ku, Tokyo

TEL

03-3542-2511

Email

thamaguc@ncc.go.jp


Public contact

Name of contact person

1st name
Middle name
Last name Satoru Iwasa

Organization

National Cancer Center Hospital

Division name

Gastrointestinal Oncology Division

Zip code


Address

5-1-1 Tsukiji, Chuo-ku, Tokyo

TEL

03-3542-2511

Homepage URL


Email

siwasa@ncc.go.jp


Sponsor or person

Institute

National Cancer Center Hospital

Institute

Department

Personal name



Funding Source

Organization

Japan Society of Clinical Oncology

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

2012 Year 11 Month 19 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

http://meetinglibrary.asco.org/content/175179-195

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

Main results already published

Date of protocol fixation

2012 Year 11 Month 06 Day

Date of IRB


Anticipated trial start date

2012 Year 11 Month 19 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

2012 Year 11 Month 17 Day

Last modified on

2017 Year 05 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010981


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name