UMIN-CTR Clinical Trial

Public title

A Phase II Study of TS-1 + CDDP + Lentinan combination chemotherapy for unresectable or recurrent gastric cancer

Acronym

A Phase II Study of TS-1 + CDDP + Lentinan in advanced gastric cancer

Scientific Title

A Phase II Study of TS-1 + CDDP + Lentinan combination chemotherapy for unresectable or recurrent gastric cancer

Scientific Title:Acronym

A Phase II Study of TS-1 + CDDP + Lentinan in advanced gastric cancer

Region

Japan

Condition

unresectable or recurrent gastric cancer

Classification by specialty

Gastroenterology	Hematology and clinical oncology	Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate the safety and efficacy of TS-1 + CDDP + Lentinan combination chemotherapy for unresectable or recurrent gastric cancer.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Time to Treatment Failure (TTF)

Key secondary outcomes

Response Rate (RR)
Overall survival (OS)
Progression Free Survival (PFS)
Safety

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

TS-1 : 80mg/m2/day po on Days 1-14
Cisplatin : 60mg/m2 iv on Day 1
Lentinan : 2mg/body iv on Day 1 , 8, 15

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

20

years-old

<=

Age-upper limit

75

years-old

>

Gender

Male and Female

Key inclusion criteria

1. Histologically confirmed gastric adenocarcinoma.
2. Measurable or evaluable lesion is confirmed within 28 days before enrollment. Presence of measurable and evaluable lesion is not required.
3. No prior chemotherapy or radiotherapy for gastric cancer.
4. Adequate baseline organ and marrow function within 14 days before enrollment as defined below;
a. Hemoglobin : >= 8.0g/dL
b. Leukocytes : 3,500-12,000/mm3
c. Absolute neutrophil count : >= 2,000/mm3
d. Platelets : >= 100,000/mm3
e. Total bilirubin : <= 1.5mg/dL
f. AST (SGOT)/ALT (SGPT) : < 100IU/L
g. ALP : <= twice institution baseline
h. Creatinine clearance : >= 60mL/min
5. Performance status (ECOG scale) 0 &#8211; 2
6. Expected survival : >= 3 months
7. Age 20-75
8. Patients able to take orally
9. Patients should sign a written informed consent.

Key exclusion criteria

1. Patients who are contraindicated to S-1, CDDP, and Lentinan.
2. Patients with active infection.
3. Patient with a previous history of congestive heart failure.
4. Serious complication as followings ;
a. Short bowel obstruction
b. Interstitial pneumonia, Pulmonary fibrosis
c. Uncontrolled diabetes mellitus
d. Renal failure
e. Hepatic failure
5. Patients with massive ascites or pleural effusion.
6. Patient with bone metastasis.
7. Patient with brain metastases or previous history of brain metastasis.
8. Patients with fresh bleeding from gastric cancer and/or the digestive tract.
9. Patients with diarrhea (4 or more times per day or watery diarrhea).
10. Patients who take psychotropic drug.
11. Patients with second primary malignancy.
12. Women in pregnancy, at risk of pregnancy, hoping to become pregnant.
13. Men who want their partners to become pregnant.
14. Any patients judged by the investigator to be unfit to participate in the study.

Target sample size

35

Name of lead principal investigator

1st name
Middle name
Last name	Hirokazu Kiyozaki

Organization

Jichi Medical University, Saitama Medical Center

Division name

Department of Surgery

Zip code

Address

1-847 Amanuma-cho, Saitama city, Saitama pref., Japan

TEL

Email

Name of contact person

1st name
Middle name
Last name	Hirokazu Kiyozaki

Organization

Jichi Medical University, Saitama Medical Center

Division name

Department of Surgery

Zip code

Address

1-847 Amanuma-cho, Saitama city, Saitama pref., Japan

TEL

Homepage URL

Email

Institute

Jichi Medical University

Institute

Department

Personal name

Organization

none

Organization

Division

Category of Funding Organization

Self funding

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

2013

Year

05

Month

15

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Open public recruiting

Date of protocol fixation

2012

Year

04

Month

01

Day

Date of IRB

Anticipated trial start date

2012

Year

04

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2013

Year

05

Month

15

Day

Last modified on

2013

Year

05

Month

15

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012534