UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021641
Receipt number R000024899
Scientific Title Perioperative CapeOx therapy for clinical stage III gastric cancer; a phase II study (OGSG1601)
Date of disclosure of the study information 2016/04/01
Last modified on 2022/11/06 00:30:37

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Basic information

Public title

Perioperative CapeOx therapy for clinical stage III gastric cancer; a phase II study (OGSG1601)

Acronym

Perioperative CapeOx therapy for clinical stage III gastric cancer; a phase II study (OGSG1601)

Scientific Title

Perioperative CapeOx therapy for clinical stage III gastric cancer; a phase II study (OGSG1601)

Scientific Title:Acronym

Perioperative CapeOx therapy for clinical stage III gastric cancer; a phase II study (OGSG1601)

Region

Japan


Condition

Condition

Gastric Cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Eevaluate the efficacy of perioperative CapeOx therapy in patients with clinical stage III gastric cancer.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

pathological response rate

Key secondary outcomes

1.Percent completion (PC) of the protocol treatment
2.Relative Dose Intensity (RDI) of neoadjuvant chemotherapy
3.Percent completion of adjuvant chemotherapy
4.Overall survival
5.Relapse free survival
6.Response Rate (RR)
7.Incidence of adverse events on neoadjuvant chemotherapy
8.Incidence of a postoperative complication
9.Relative Dose Intensity(RDI) of adjuvant chemotherapy


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


Not applicable

Gender

Male and Female

Key inclusion criteria

1) Histologically proven gastric adenocarcinoma
2) Clinically diagnosed cSS/SE N1-3 MO gastric cancer
3) Aged 20 years old or over
4) ECOG performance status of 0 or 1
5) Possible oral intake
6) Adequate organ function
a. neutrophilic count : => 1500/mm3
b. hemoglobin : => 8g/dL
c. platelet : => 100,000/mm3
d. AST, ALT : =< 100 IU/L
e. total bilirubin : =< 2mg/dL
f. creatinine clearance : => 50mL/min
7) Wrriten informed consent from patient

Key exclusion criteria

1) With active double cancers
2) Past history of severe hypersensitivity to drugs
3) With active infection
4) Pregnant women, or women with the possibility of the pregnancy
5) Men who want let to pregnancy
6) History of myocardial infarction within 6 months
7) Continuous systemic steroid therapy
8) Under treatment with flucytosine, phenytoin
9) Severe diarrhea
10) Positive HBs antigen
11) Severe complications
12) Bulky lymph node metastasis, Borrmann type 4 or large type 3
13) Patients juged inappropriate for the study by the physicians

Target sample size

37


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masahiro Gotou

Organization

Osaka Medical College Hospital

Division name

Chemotherapy Center

Zip code


Address

2-7 Daigaku-machi, Takatsuki City , Osaka, 569-8686

TEL

072-683-1211

Email

in2030@poh.osaka-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tetsuji Terazawa

Organization

Osaka Medical College Hospital

Division name

Chemotherapy Center

Zip code


Address

2-7 Daigaku-cho, Takatsuki, Osaka, 569-8686

TEL

072-683-1211

Homepage URL


Email

terasawat@poh.osaka-med.ac.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

大阪医科大学(大阪府)


Other administrative information

Date of disclosure of the study information

2016 Year 04 Month 01 Day


Related information

URL releasing protocol

https://academic.oup.com/oncolo/article/25/2/119/6443288?login=false#google_vignette

Publication of results

Published


Result

URL related to results and publications

https://academic.oup.com/oncolo/article/25/2/119/6443288?login=false#google_vignette

Number of participants that the trial has enrolled

37

Results

Thirty-seven patients were enrolled in CapeOx. Am R0 resection rate of 78.4%(n=29) and a pathological response rate of 54.1%(n=20,p=0.058; 90% confidence interval[CI],39.4-68.2)were demonstrated. among 27 patients who initiated five cycles of adjuvant CapeOx, 21(63.6%) completed the treatment.

Results date posted

2022 Year 11 Month 06 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2019 Year 09 Month 30 Day

Baseline Characteristics

clinical T3(SS)/T4a(SE) N1-3 M0 GC according to the Japanese Classification of Gastric Carcinoma-3rd English Edition (JCGC)

Participant flow

Thirty-seven pts were enrolled from July 2016 to May 2017.

Adverse events

grade 4 neutropenia
grade 2 anorexia and fatigue
grade 2 allergic reaction
nausea and vomiting

Outcome measures

Primary endpoint: Pathological response rate
Secondary endpoint:
The 3-year recurrence-free survival rate
Percentage completion of the protocol treatment
Relative dose intensity(RDI) of neoadjuvant chemotherapy
RDI of adjuvant chemotherapy
The 3-year overall survival rate
Percentage completion of adjuvant chemotherapy
Overall response rate
Safety
Surgical complications

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2016 Year 02 Month 05 Day

Date of IRB

2016 Year 03 Month 07 Day

Anticipated trial start date

2016 Year 07 Month 07 Day

Last follow-up date

2020 Year 07 Month 04 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2020 Year 09 Month 28 Day


Other

Other related information



Management information

Registered date

2016 Year 03 Month 27 Day

Last modified on

2022 Year 11 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024899


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name