UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005708
Receipt number R000006750
Scientific Title Assessment of optimal dosage and biomarker in capecitabine plus fractional cisplatin as the first-line therapy in patients with advanced or recurrent gastric cancer.
Date of disclosure of the study information 2011/06/02
Last modified on 2015/04/21 08:34:42

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Basic information

Public title

Assessment of optimal dosage and biomarker in capecitabine plus fractional cisplatin as the first-line therapy in patients with advanced or recurrent gastric cancer.

Acronym

Assessment of optimal dosage and biomarker in capecitabine plus fractional cisplatin as the first-line therapy in patients with advanced or recurrent gastric cancer.
(KOGC-05 Trial)

Scientific Title

Assessment of optimal dosage and biomarker in capecitabine plus fractional cisplatin as the first-line therapy in patients with advanced or recurrent gastric cancer.

Scientific Title:Acronym

Assessment of optimal dosage and biomarker in capecitabine plus fractional cisplatin as the first-line therapy in patients with advanced or recurrent gastric cancer.
(KOGC-05 Trial)

Region

Japan


Condition

Condition

Patients with unresctable or recurrent gastric cancer.

Classification by specialty

Gastroenterology Hematology and clinical oncology Gastrointestinal surgery
Adult

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To assess maximum tolerated dose in order to determine recommended dose of capecitabine plus fractional cisplatin as the first-line therapy in patients with resectable or recurrent gastric cancer.
Furthermore, this exploratory study is also designed to evaluate predictable several factor levels in the resected tumor tissues and plasma from the registrated patients.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase I


Assessment

Primary outcomes

Incidence of dose limiting toxicity

Key secondary outcomes

Overall Response rate
Exploring several predictable biomarkers


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

Capecitabine plus fractional cisplatin:

Level 1
Capecitabine:2,000mg/m2/day p.o.(day1-15)
Cisplatin:15mg/m2 i.v.
(day1, 8, 15)
to be repeated every 3 weeks.

Cisplatin is administered with an initial dose of 15mg/m2, stepped up to 20mg/m2 or 25mg/m2.

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

74 years-old >=

Gender

Male and Female

Key inclusion criteria

(1) Histological confirmation of gastric adenocarcinoma.
(2) Patients with an advanced or recurrent gastric cancer with estimative lesion, and had received no previous chemotherapy.
i) Patients with unresectable gastric cancer who had not received any intervention except surgical procedure.
ii) Patients with recurrent gastric cancer who had not been treated by any therapy against for the recurrent site.
(3) Patient who are possible to be orally administrated capecitabene.
(4) Eastern Cooperative Oncology Group (ECOG) performance status (PS): 0 - 1.
(5) 20 years old or more,and 74 years old or less when received informed consent.
(6) Written informed consent.
(7) Life expectancy estimate 3 months, and more.
(8) Vital organ functions (listed below) are preserved within 14 days prior to entry.
i) White blood cell count >= 4,000/mm3
Neutrophils>=2,000/mm3
ii) Platelets>=100,000/mm3
iii).Hemoglobin>=9.0 g/dl
iv).Total bilirubin<=1.5 mg/dl
v). AST and ALT <= 100 I/U
vi). Serum albumin >= 2.5 g/dl
vii). Serum creatinine <= 1.2 mg/dl
or estimated creatinine clearance rate ( Cockcroft-Gault formula) >= 60 mL/min

Key exclusion criteria

(1) Patients who had previously received chemotherapy including a fluorouracil-based regimen at least 6 month before registration.
(2) Patients who had previously received chemotherapy including a Platinum-based regimen.
(3) Patients with history of severe adverse event suspected to be caused by dihydropyrimidine dehydrogenase (DPD) deficiency.
(4) Patients who have history of active simultaneous or metachronous double cancers within 5 year.
However, patient with carcinoma in situ or intramucosal carcinoma curable with local therapy is excluded for active double cancer.
(5) Patients With severe or uncontrolled complication (infection, pulmonary fibrosis, intestinal paralysis, intestinal obstruction, uncontrolled diabetes mellitus, liver cirrhosis, history of myocardial infarction within 6 month, unstable angina, and so on.)
(6) Patients with pericardial fluid or massive pleural or peritoneal fluid that required drainage.
(7) Patients with CNS metastases only.
(8) Patients with gastrointestinal bleeding which require a repeat blood transfusion.
(9) Patient who have been treated with antipsychotic drugs, or patient with mental disorder requiring medication.
(10) Patient with recurrent gastric cancer have had history of severe diarrhea (>=Grade 3) in previous adjuvant chemotherapy.
(11) Patients with diarrhea (increase of 4 and more stool frequency per day over baseline or watery stool ) at registration.
(12) Patients who have been treated with antithrombotic drug or drugs affected to coagulation and fibrinolytic system within 2 weeks before registration by the physician decision (Except for low-dose of aspirin).
(13) Patients who are pregnant women, possibly pregnant women, willing to become pregnant, and nursing mothers.
(14) Patients who have condition corresponding with contraindication for the administration of Capecitabine and Cisplatin.
(15) Patients who are inappropriate for the study at the physician's assessment

Target sample size

18


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yuko Kitagawa

Organization

School of Medicine, Keio University

Division name

Department of Surgery

Zip code


Address

35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan

TEL

03-3353-2681

Email



Public contact

Name of contact person

1st name
Middle name
Last name Tsunehiro Takahashi

Organization

School of Medicine, Keio University

Division name

Department of Surgery

Zip code


Address

35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan

TEL

03-3353-2681

Homepage URL


Email



Sponsor or person

Institute

Department of Surgery, School of Medicine, Keio University

Institute

Department

Personal name



Funding Source

Organization

None

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



Other administrative information

Date of disclosure of the study information

2011 Year 06 Month 02 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


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

Completed

Date of protocol fixation

2011 Year 05 Month 13 Day

Date of IRB


Anticipated trial start date

2011 Year 06 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2011 Year 06 Month 02 Day

Last modified on

2015 Year 04 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006750


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name