UMIN-CTR Clinical Trial

Public title

A phase II study of systemic chemotherapy with S-1 and Oxaliplatin followed by gastrectomy with D2 or D2 plus limited para-aortic lymph node dissection in HER2 negative advanced gastric or esophagogastric junction cancer with extensive lymph node metastasis

Acronym

A phase II study of systemic chemotherapy with S-1 and Oxaliplatin followed by gastrectomy with D2 or D2 plus limited para-aortic lymph node dissection in HER2 negative advanced gastric or esophagogastric junction cancer with extensive lymph node metastasis

Scientific Title

A phase II study of systemic chemotherapy with S-1 and Oxaliplatin followed by gastrectomy with D2 or D2 plus limited para-aortic lymph node dissection in HER2 negative advanced gastric or esophagogastric junction cancer with extensive lymph node metastasis

Scientific Title:Acronym

A phase II study of systemic chemotherapy with S-1 and Oxaliplatin followed by gastrectomy with D2 or D2 plus limited para-aortic lymph node dissection in HER2 negative advanced gastric or esophagogastric junction cancer with extensive lymph node metastasis

Region

Japan

Condition

Gastric cancer

Classification by specialty

Gastroenterology	Hematology and clinical oncology	Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate efficacy and safety of gastrectomy with D2 or D2 plus limited para-aortic lymph node dissection in HER2 negative advanced gastric or esophagogastric junction cancer with extensive lymph node metastasis following systemic chemotherapy with S-1 and Oxaliplatin

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Others

Trial characteristics_2

Others

Developmental phase

Phase II

Primary outcomes

3-year overall survival

Key secondary outcomes

Proportion of R0 resection, 5-year overall survival, 3- and 5-year recurrence free survival, Proportion of completion of surgery, Proportion of completion of protocol treatment, Clinical response rate, Pathological response rate, Adverse events from chemotherapy, Operation time, Intraoperative blood loss, Surgical complications, Postoperative hospital stay

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

Maneuver

Interventions/Control_1

Gastrectomy with D2 or D2 plus dissection of para-aortic lymph nodes diagnosed as metastases at initial diagnosis is performed after three or four 21-day cycles of S-1 plus oxaliplatin. S-1 is also given for 1 year after gastrectomy.

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 proven gastric adenocarcinoma
2) HER2 negative (IHC 0 or IHC 1+, or IHC 2+/FISH -)
3) One of the following conditions is fulfilled by enhanced CT
1. Paraaortic lymph node metastasis (No.16a2/ 16b1)
2. Bulky N (at least one node of 3 cm or more in diameter, or at least three consecutive nodes each of diameter 1.5 cm or more, along the coeliac, splenic, common or proper hepatic arteries or superior mesenteric vein.)
3. Both of No.16a2/ 16b1 and bulky lymph node metastasis
4. Thoracic/ abdominal/ pelvic enhanced CT reveals none of the following findings:
i) Mediastinal lymph node metastasis
ii) Lung metastasis
iii) Peritoneal metastasis
iv) Liver metastasis
v) Pleural effusion, ascites beyond the pelvis
vi) Paraaortic No. 16a1 or No. 16b2 swelling 1cm or greater
vii) Other distant metastases (except for No. 13, No. 16a2 or No. 16b1 metastasis)
5) Neither Borrmann type 4 nor large (8cm or more) type 3
6) Length of esophageal invasion less than or equal to 3cm
7) Not stump cancer of stomach.
8) Clinically no sign of distant metastasis
9) No liver or peritoneal metastasis and CY0 by laparoscopy or laparotomy for bypass surgery within 28 days before registration
10) Age between 20 and 75 at registration
11) Performance Status (ECOG) 0 or 1
12) No prior chemotherapy, radiotherapy or endocrinotherapy
13) No prior surgery for gastric carcinoma except for bypass surgery and endoscopic mucosal resection
14) Fair oral intake with or without bypass surgery
15) Adequate organ functions defined as indicated below;
i) WBC >= 4,000/mm3 and <= 12,000/mm3
ii) Neutrophils >= 4,000/mm3
iii) Hb >= 8.0 g/dl
iv) Platelet >= 100,000/mm3
v) AST <= 100IU
vi) ALT <= 100IU
vii) T.bil <= 1.5 mg/dL
viii) Creatinine <= 1.2 mg/dL
viii) Ccr >= 60 mL/min/body
16) Written informed consent

Key exclusion criteria

1) Synchronous or metachronous (within 5 years) malignancies other than carcinoma in situ or mucosal cancer
2) Women during pregnancy or breast-feeding
3) Severe mental disease
4) Under treatment with systemic steroid
5) HBs antigen positive
6) Under treatment with flucytosine, phenytoin, or warfarin
7) Allergy to iodine
8) History of hypersensitivity to oxaliplatin or S-1
9) Peripheral motor neuropathy or peripheral sensory neuropathy by any reason
10) Edema of limbs or trunk by any reason
11) Interstitial pneumonia, pulmonary fibrosis or severe emphysema.
12) Active bacterial or fungal infection
13) Past history of myocardial infarction or unstable angina pectoris within 6 months
14) Uncontrollable hypertension
15) Uncontrollable diabetes mellitus or routine administration of insulin

Target sample size

35

Name of lead principal investigator

1st name
Middle name
Last name	Takeshi Sano

Organization

Cancer Institute Hospital

Division name

Division of gastroenterological surgery

Zip code

Address

3-8-31, Ariake, Koto-ku, Tokyo, 135-8550, Japan

TEL

03-3520-0111

Email

takeshi.sano@jfcr.or.jp

Name of contact person

1st name
Middle name
Last name	Koshi Kumagai

Organization

Cancer Institute Hospital

Division name

Division of gastroenterological surgery

Zip code

Address

3-8-31, Ariake, Koto-ku, Tokyo, 135-8550, Japan

TEL

03-3520-0111

Homepage URL

Email

koshi.kumagai@jfcr.or.jp

Institute

Cancer Institute Hospital

Institute

Department

Personal name

Organization

Self-sustaining fund

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

がん研究会有明病院（東京都）
国立がん研究センター中央病院（東京都）
静岡県立静岡がんセンター（静岡県）
国立がん研究センター東病院（千葉県）
愛知県がんセンター中央病院（愛知県）

Date of disclosure of the study information

2017

Year

07

Month

01

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

2017

Year

05

Month

25

Day

Date of IRB

2019

Year

02

Month

21

Day

Anticipated trial start date

2017

Year

09

Month

01

Day

Last follow-up date

2027

Year

09

Month

28

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2017

Year

05

Month

26

Day

Last modified on

2023

Year

09

Month

07

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031497