UMIN-CTR Clinical Trial

Public title

A PhaseII study of XP(capecitabine plus cisplatin) combination therapy for HER2 negative advanced/recurrent gastric cancer

Acronym

SGCSG G-04

Scientific Title

A PhaseII study of XP(capecitabine plus cisplatin) combination therapy for HER2 negative advanced/recurrent gastric cancer

Scientific Title:Acronym

SGCSG G-04

Region

Japan

Condition

HER2 negative advanced/recurrent gastric cancer

Classification by specialty

Gastroenterology

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

Efficacy and safety assessment of XP therapy for HER2 negative advenced and recurrent gastric cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Primary outcomes

Response rate

Key secondary outcomes

Time to response, Disease control rate, Progression free survival, Time to treatment failure, Overall survival, Relative dose intensity, safety

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

CDDP80mg/m2, Day1
Capecitabine2000mg/m2, Day1-15
Tri-weekly, until PD

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

Not applicable

Gender

Male and Female

Key inclusion criteria

(1)Non-curative resected or recurrent gastric cancer histologically proven adenocarcinoma(included EGJ cancer).
(2)Negatibe HER2 status if tested.
(3)Written informed consent to receive this chemotherapy.
(4)20 years old or more than 20 years old.
(5)Eastern Cooperative Oncology Group(ECOG) performance status 0-2.
(6)Life expectancy of at least 3 months after registration.
(7)Case which has lesions to be measureable and non-measureable according to RECIST(Response Evaluation Criteria in Solid Tumors) guideline.
(8)Adequate organ function as follows:
1.Nuetrophils count more than 1,500/mm3
2.Platelet count more than 100,000/m3
3.Serum bilirubin level than 1,5mg/dl
4.AST and ALT less than 100IU/l
5.Serum creatinine level less than 1.2mg/dl
6.Cretinine clearance more than 50mL/min
(9)Without previous chemotherapy(except adjuvant chemotherapy).

Key exclusion criteria

(1)Forbidden case to use capecitabine and cisplatin.
(2)R1 operation(histologically positive PM, OM, LM, VM).
(3)Infection or inflammatory case.
(4)Severe heart disease.
(5)Severe complicated case such as ileus, intestitial pneumonia, uncontrolled DM, liver cirrhosis etc.
(6)Difficulty to join the trial due to psychosis nervous system damage.
(7)Complicated other active cancer.
(8)patient who want to be pregnant and/or pregnant woman.
(9)Intend to make pregnant.
(10)Active hepatitis type HB positive(HBs antigen, HBc antibody and HBs antibody).
(11)Otherwise determined by investigators or site principal investigators to be unsuitable for participation in study).

Target sample size

36

Name of lead principal investigator

1st name
Middle name
Last name	Noriyuki Hirahara

Organization

Shimane university faculty of medicine

Division name

Department of digestive and general surgery

Zip code

Address

89-1 Enya-cho, Izumo city, Shimane prefecture, 693-8501, Japan

TEL

0853-20-2232

Email

norinori@med.shimane-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Noriyuki Hirahara

Organization

Shimane university faculty of medicine

Division name

Department of digestive and general surgery

Zip code

Address

89-1 Enya-cho, Izumo city, Shimane prefecture, 693-8501, Japan

TEL

0853-20-2232

Homepage URL

Email

norinori@med.shimane-u.ac.jp

Institute

SGCSG:Shimane Gstroenterological Vancer Study Group

Institute

Department

Personal name

Organization

SGCSG:Shimane Gstroenterological Vancer Study Group

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

2014

Year

04

Month

08

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

Enrolling by invitation

Date of protocol fixation

2013

Year

12

Month

03

Day

Date of IRB

Anticipated trial start date

2014

Year

04

Month

08

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2014

Year

04

Month

08

Day

Last modified on

2014

Year

04

Month

08

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015951