UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028749
Receipt number R000032844
Scientific Title A phase II study of perioperative capecitabine plus Oxaliplatin(CapeOx) therapy for advanced gastric cancer with multiple lymph node metastases (OGSG 1701)
Date of disclosure of the study information 2017/09/01
Last modified on 2022/08/28 17:59:57

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Basic information

Public title

A phase II study of perioperative capecitabine plus Oxaliplatin(CapeOx) therapy for advanced gastric cancer with multiple lymph node metastases
(OGSG 1701)

Acronym

A phase II study of perioperative capecitabine plus Oxaliplatin(CapeOx) therapy for advanced gastric cancer with multiple lymph node metastases
(OGSG 1701)

Scientific Title

A phase II study of perioperative capecitabine plus Oxaliplatin(CapeOx) therapy for advanced gastric cancer with multiple lymph node metastases
(OGSG 1701)

Scientific Title:Acronym

A phase II study of perioperative capecitabine plus Oxaliplatin(CapeOx) therapy for advanced gastric cancer with multiple lymph node metastases
(OGSG 1701)

Region

Japan


Condition

Condition

Gastric Cancer

Classification by specialty

Gastroenterology Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To confirm the efficacy and safety of perioperative Capecitabine plus Oxaliplatin combined chemotherapy (CapeOx) for advanced gastric cancer with multiple lymph node metastases which cannot be resected curatively, or very poor prognosis.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

Response Rate(RR)(RECISTv1.0)

Key secondary outcomes

1.Overall survival(OS)
2.Progression free survival
3.Rate of curative resection
4.Complete rate of protocol
5.Complete rate of preoperative chemotherapy
6.Complete rate of operation
7.Complete rate of postoperative chemotherapy
8.Relative Dose Intensity (RDI)
9.Response Rate of Histologically
10.Incidence of adverse events on perioperative chemotherapy
11.Incidence of a intraoperative and postoperative complication
12.Response Rate (RR)(RECISTv1.1)


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine Other

Interventions/Control_1

preoperative CapeOx therapy
Capecitabine : 1,000mg/m2 bid, day1-14, q3w
Oxaliplatin : 130mg/m2, day 1, q3w
3 cycle
Surgery
Postoperative CapeOx therapy
Capecitabine : 1,000mg/m2 bid, day1-14, q3w
Oxaliplatin : 130mg/m2, day 1, q3w
5 cycle

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



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

75 years-old >=

Gender

Male and Female

Key inclusion criteria

1)Histologically proven gastric carcinoma by endoscopic detection
2)HER2 negative or unknown
3)With any lesion written below by upper abdominal enhanced CT:
1.Paraaortic node metastases (#16a2/16b1) larger than 10mm
2.Bulky lymph node metastases located at celiac axis, common hepatic artery, splenic artery and/or upper mesenteric vein which make a huge bulk larger than 3.0 cm and/or multiple
large bulks larger than 1.5 cm
3.Paraaortic and bulky metastatic nodes
4)Without any lesions written below by thoratic, upper abdominal and pelvic enhanced CT:
1.mediastinal node metastases
2.lung metastases
3.peritoneal metastases
4.liver metastases
5.pleural fluid and/or ascites
6.paraaortic nodes metastases (# 16a1 and/or #16b2)
7.Other distant nodes metastases and/or CY1
5) Not a large type 3 or type 4 gastric cancer
Large: the size of cancer is larger than 8 cm
6)Without esophageal invasion longer than 3 cm
7)Not a remnant gastric cancer
8)Without cervical nodes metastases and/or distant metastases
9)Age between 20 and 75 years old
10)An Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
10)An Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
11) Without any prior chemotherapy, radiation therapy and/or hormone therapy for the gastric cancer and/or any other cancers
12)Without prior surgical therapy except EMR/ESD and/or bypass
13) Patients can take food orally with /without bypass
14) With good functions of important organs by a data taken within 2 weeks
of registration
1.Neutrophil: =>1,500/mm3
2.Hemoglobin: =>8.0 g/dL without blood transfusion
3.Platelet: =>100,000/mm3
4.AST, ALT: =< 100 IU/L
5.T.bil.: =<2.0 mg/dL
6.Creatinine clearance: =>60 ml/min/body
CC by Cockcroft-Gault method is available:=>60mL/min
15) With written Informed Consent

Key exclusion criteria

1)With active double cancers excluding carcinoma in situ and/or prior cancer cured with longer than 5 year interval period
2)Pregnant or nursing female
3)Male expecting pregnancy of partner
4)Impossible to register to the study due to a psychological disorder by physician in charge's decision
5)Under continuous steroids medication
6)Patients who receives systemic continuous administration of phenytoin or warfarin potassium
7)With neuropathy on peripheral motor and/or sensory nerves: -> glade 2 of CTCAE v4.0
8)With interstitial pneumonitis, pulmonary fibrosis and/or severe pulmonary emphysema
9)With active bacterial/fungal infectious disease (with a fever over 38 centigrade)
10)With a history of cardiac infarction and/or anxiety angina pectoris within 6 months
11)With uncontrollable blood hypertension
12)With uncontrollable DM
13)With uncontrollable Diarrhea
14)Positive HBs antigen
15)Severe complications
16)Any other patients whom the physician in charge of the study judges to
be unsuitable

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yutaka Kimura

Organization

Kindai University School of Medicine

Division name

Department of Surgery

Zip code


Address

377-2, Ohnohigashi , Osakasayama, Osaka, 589-8511, Japan

TEL

072-366-0221

Email

you-kimura@surg.med.kindai.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Naotoshi Sugimoto

Organization

Osaka International Cancer Institute

Division name

Department of medical oncology

Zip code


Address

3-1-69, Otemae, chuoh-ku, Osaka, 541-8567, Japan

TEL

06-6945-1181

Homepage URL


Email

sugimoto-na2@mc.pref.osaka.jp


Sponsor or person

Institute

Osaka Gastrointestinal Cancer Chemotherapy Study Group (OGSG)

Institute

Department

Personal name



Funding Source

Organization

Yakult Honsha Co.,Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

市立東大阪医療センター(大阪府)、近畿大学(大阪府)、佐野病院(兵庫県)、関西労災病院(兵庫県)、箕面市立病院(大阪府)、大阪医科大学附属病院(大阪府)、相澤病院


Other administrative information

Date of disclosure of the study information

2017 Year 09 Month 01 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled

30

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



Progress

Recruitment status

No longer recruiting

Date of protocol fixation

2017 Year 06 Month 30 Day

Date of IRB

2017 Year 09 Month 06 Day

Anticipated trial start date

2018 Year 02 Month 02 Day

Last follow-up date

2025 Year 06 Month 12 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 08 Month 20 Day

Last modified on

2022 Year 08 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032844


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name