UMIN-CTR Clinical Trial

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

Elderly patients with metastatic gastric cancer

Classification by specialty

Hepato-biliary-pancreatic medicine

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO

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

Primary outcomes

Overall survival

Key secondary outcomes

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

National Cancer Center Hospital

Institute

Department

Personal name

Organization

Japan Society of Clinical Oncology

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2012

Year

11

Month

19

Day

URL releasing protocol

Publication of results

Published

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

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 related 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