UMIN-CTR Clinical Trial

Public title

Phase I/II trial of neoadjuvant S-1/CDDP with concurrent radiation for locally Advanced gastric cancer

Acronym

Phase i/II trial of neoadjuvant chemoradiotherapy for locally Advanced gastric cancer

Scientific Title

Phase I/II trial of neoadjuvant S-1/CDDP with concurrent radiation for locally Advanced gastric cancer

Scientific Title:Acronym

Phase i/II trial of neoadjuvant chemoradiotherapy for locally Advanced gastric cancer

Region

Japan

Condition

Gastric cancer

Classification by specialty

Gastroenterology	Gastrointestinal surgery	Radiology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

Phase I
Primary objective is to estimate the maximum tolerated dose (MTD) and recommended dose (RD) of neoadjuvant chemoradiotherapy of S-1 with CDDP for locally advanced gastric cancer.
Phase II
Primary objective is to estimate the pathological response rate when administered at recommended dose estimated in Phase I.

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase I

Primary outcomes

Phase I
estimate the maximum tolerated dose (MTD)and recommended dose (RD) of adjuvant chemotherapy of S-1 with CDDP
Phase II
Pathological response rate

Key secondary outcomes

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

[Phase I]
S-1 with CDDP neoadjuvant chemoradiotherapy is conducted. S-1 is orally administered for 14 days followed by 14 days rest according to body surface area. CDDP is administered intravenously in each dosage of level at day 1 and 15. Radiation is delivered a dose of 40 Gy (20 fractions of 2.0 Gy) during 4 weeks.

[Phase II]
At the first course of neoadjuvant TS-1/CDDP with concurrent radiotherapy, TS-1/CDDP is administered at the second course. After more than 3 weeks from last administration of chemotherapy, gastrectomy is executed.
At the chemoradiotherapy, S-1 is orally administered for 14 days followed by 14 days rest according to body surface area. CDDP is administered intravenously in each dosage of level at day 1 and 15. Radiation is delivered a dose of 40 Gy (20 fractions of 2.0 Gy) during 4 weeks.
At the chemotherapy, S-1 is orally administered for 28 days followed by 14 days rest according to body surface area. CDDP 20mg/m2 is administered intravenously at day 1, 15, 29.

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

80

years-old

>

Gender

Male and Female

Key inclusion criteria

1) confirmed gastric cancer by endscopic biopsy
2) eligible to below
i) clinico pathological clasification type is 3 or 4.
ii) has advanced lymph node metastasis
3) with no distant metastasis, liver metastasis, peritoneal metastasis and negative peritoneal cytology
4) esophagus invation <= 3cm
5) age: >=20 and <80
6) P.S. 0 or 1
7) No prior treatment
8) possible to oral intake
9) sufficient function of important organs
10) written informed consent

Key exclusion criteria

1) known sever drug allergies
2) with clinically important infection
3) with diarrhea
4) with intestinal paralysis or ileus
5) with interstitial pneumonia or pulmonary fibrosis
6) has history of radiation to chest or ilium
7) has active carcinoma
8) with uncontrollable diabetes mellitus
9) has complication which is clinically probrem
10) with clinically important mental disorder need to treat
11) pregnant or nursing women or women who like be pregnant and willing to get pregnant
12) administered flucytosine
13) being blood transfusion or need to blood transfusion
14) doctor's decision not to be registered to this study

Target sample size

52

Name of lead principal investigator

1st name
Middle name
Last name	Yuko Kitagawa

Organization

School of Medicine, Keio University

Division name

Department of Surgery

Zip code

Address

35 Shinanomachi, Shinjuku-ku, Tokyo, Japan

TEL

Email

Name of contact person

1st name
Middle name
Last name

Organization

School of Medicine, Keio University

Division name

Department of Surgery

Zip code

Address

TEL

Homepage URL

Email

tsunehiro-t@a8.keio.jp

Institute

School of Medicine, Keio University

Institute

Department

Personal name

Organization

School of Medicine, Keio University

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

2012

Year

09

Month

19

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

Terminated

Date of protocol fixation

2011

Year

03

Month

01

Day

Date of IRB

Anticipated trial start date

2011

Year

05

Month

13

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

09

Month

19

Day

Last modified on

2015

Year

04

Month

21

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010483