UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000016256
Receipt number R000018781
Scientific Title A phase II study of capecitabin plus oxaliplatin therapy (XELOX) for inoperable/advanced gastric cancer resistant/intolerable to fluoro-pyrimidine, CDDP, Taxane or CPT-11 (OGSG1403)
Date of disclosure of the study information 2015/01/19
Last modified on 2020/09/06 16:02:07

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Basic information

Public title

A phase II study of capecitabin plus oxaliplatin therapy (XELOX) for inoperable/advanced gastric cancer resistant/intolerable to fluoro-pyrimidine, CDDP, Taxane or CPT-11 (OGSG1403)

Acronym

A phase II study of capecitabin plus oxaliplatin therapy (XELOX) for inoperable/advanced gastric cancer resistant/intolerable to fluoro-pyrimidine, CDDP, Taxane or CPT-11 (OGSG1403)

Scientific Title

A phase II study of capecitabin plus oxaliplatin therapy (XELOX) for inoperable/advanced gastric cancer resistant/intolerable to fluoro-pyrimidine, CDDP, Taxane or CPT-11 (OGSG1403)

Scientific Title:Acronym

A phase II study of capecitabin plus oxaliplatin therapy (XELOX) for inoperable/advanced gastric cancer resistant/intolerable to fluoro-pyrimidine, CDDP, Taxane or CPT-11 (OGSG1403)

Region

Japan


Condition

Condition

unresectable/advanced 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 capecitabin plus oxaliplatin combined chemotherapy (XELOX therapy) for unresectable/advanced gastric cancer
resistant/intolerable to fluoro-pyrimidine, CDDP, Taxane or CPT-11.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Disease Control Rate

Key secondary outcomes

Overall Survival, Progression Free Survival, Time To Failure, Response Rate, Incidence of Adverse Events


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

It takes three weeks for a one course of oxaliplatin plus capecitabin combination therapy (XELOX). Patients undergo this treatment until progression or severe AE.

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 carcinoma or adenocarcinoma on the esophago-gastric junction
2)resistant /intolerable to fluoropyrimydine, CDDP, CPT-11 or Taxane
3)age over than 20 years old
4)Performance Status by Eastern Cooperative Oncology Group of 0,1 or 2.
5)with measurable lesions (RESIST ver. 1.1)
6)Patients who can take food orally
7)expected survival period longer than 3 months
8)with a rest longer than 14 days after the end of prior therapy
9) with good functions of important organs
1. Neutrophil: =>1,500/mm3
2. Hemoglobin: =>8.0 g/dl without blood transfusion within 14 days
3. Platelet: =>100,000/mm3
4. AST, ALT: =< 100 IU/L
5. T.bil.: =<1.5 mg/dL
6. s-cleatinine: =<1.2mg/dL
10) with a peripheral neuropathy lower than Grade 1
11) with written Informed Consent

Key exclusion criteria

1)With prior chemotherapy including oxaliplatin (L-OHP)
2)With some active double cancers
3)With severe complications
4)With active infectious diseases which need treatments
5)With thoracic fluid and/or ascites which need drainage
6)under continuous steroids medication
7)under medication of phenytoin and/or warfarin
8)with active bleeding which needs frequent blood transfusion
9)with central nerve metastases with symptoms
10) with psychological disorders
11) Pregnant and/or nursing women or men who like to have children
12)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 Naotosi 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

Email

sugimoto-na2@mc.pref.osaka.jp


Public contact

Name of contact person

1st name
Middle name
Last name Naotosi 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

Osaka Clinical Study Supporting Organization

Organization

Division

Category of Funding Organization

Self funding

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

箕面市立病院(大阪府)、市立貝塚病院(大阪府)、大阪国際がんセンター(大阪府)、北野病院(大阪府)、関西労災病院(兵庫県)、大阪医療センター(大阪府)


Other administrative information

Date of disclosure of the study information

2015 Year 01 Month 19 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

12

Results


Results date posted


Results Delayed

Delay expected

Results Delay Reason

manuscript in preparation

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

Terminated

Date of protocol fixation

2014 Year 11 Month 10 Day

Date of IRB

2015 Year 03 Month 20 Day

Anticipated trial start date

2015 Year 07 Month 27 Day

Last follow-up date

2019 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2019 Year 01 Month 28 Day


Other

Other related information



Management information

Registered date

2015 Year 01 Month 18 Day

Last modified on

2020 Year 09 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018781


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name