UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000003141
Receipt number R000003809
Scientific Title A randomised phase II trial of combined therapy with CPT-11/CDDP versus CPT-11 alone in second-line treatment of advaneced or recurrent gastric cancer resistant to Docetaxel/Cisplatin/TS-1 (DCS) therapy
Date of disclosure of the study information 2010/02/06
Last modified on 2014/08/06 09:29:19

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Basic information

Public title

A randomised phase II trial of combined therapy with CPT-11/CDDP versus CPT-11 alone in second-line treatment of advaneced or recurrent gastric cancer resistant to Docetaxel/Cisplatin/TS-1 (DCS) therapy

Acronym

A randomized phase II study of CPT-11/CDDP versus CPT-11 in second-line treatment of advanced/recurrent gastric cancer after DCS chemotherapy

Scientific Title

A randomised phase II trial of combined therapy with CPT-11/CDDP versus CPT-11 alone in second-line treatment of advaneced or recurrent gastric cancer resistant to Docetaxel/Cisplatin/TS-1 (DCS) therapy

Scientific Title:Acronym

A randomized phase II study of CPT-11/CDDP versus CPT-11 in second-line treatment of advanced/recurrent gastric cancer after DCS chemotherapy

Region

Japan


Condition

Condition

Gastric Cancer

Classification by specialty

Medicine in general Gastroenterology Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To demonstrate the superiority of combined therapy with CPT-11 and CDDP over CPT-11 monotherapy in patients with advanced or recurrent gastric cancer resistant to Docetaxel/Cisplatin/TS-1 (DCS) therapy.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

Progression-free survival

Key secondary outcomes

safety,response rate,overall survival,Time to Treatment Failure


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

CPT-11+CDDP
CPT-11 60mg/m2 d1
CDDP 30mg/m2 d1
repeat every 2weeks
until PD

Interventions/Control_2

CPT-11 alone
CPT-11 150mg/m2 d1
repeat every 2weeks
until PD

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

80 years-old >=

Gender

Male and Female

Key inclusion criteria

(1) Histologically proven advaneced or recurrent gastric cancer gastric adenocarcinoma.
(2) Tumor progression during or after DCS chemotherapy given as initial chemotherapy (patients with progressive disease: PD). Patients who have discontinued treatment because of adverse events were excluded.
(3) No previous treatment other than DCS chemotherapy or surgery.
(4) Received at least 1 course of DCS chemotherapy
(5) Previous DCS chemotherapy completed at least 4 weeks before.
(6) Measurable lesions according to RECIST guidelines.
(7) Age > 20 and <80 years old
(8) ECOG performance status 0-2
(9) Life expectancy over 3 months
(10) Adequate organ function.
* WBC >=;3500/mm3 and=<;12,000 mm3.
* Neutrophil count >=2,000/mm3.
* Platelet count>=;100,000/mm3.
* Hemoglobin>=;8.0 g/dL
Liver function tests
* AST (GOT) and ALT (GPT)=<;x 2.5 upper limet.
* Total bilirubin=<;1.50 mg/dL.
Renal function test
* Serum creatinine=<;1.50 mg/dL.
(10) Written informed consent.

Key exclusion criteria

(1) With uncontrolled pleural effusion or ascites.
(2) Active concomitant malignancy.
(3) With infectious disease which needs treatment.
(4) Uncontrolled medical conditions (e.g., congestive heart failure, ileus, interstitial pneumonia, pulmonary fibrosis, diabetes, interstitial pneumonia, pulmonary fibrosis, renal failure).
(5) Watery stool (diarrhea).
(6) With a history of mental disorder.
(7) Pregnant or lactating women and women of child bearing potential not using contraception.
(8) Drug hypersensitivity or severe drug allergy.
(9) Inappropriate recruit to the study judged by an investigator in charge.

Target sample size

80


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yasushi Sato

Organization

Sapporo Medical University
School of Medicine

Division name

Dept. of Internal Medicine(4)

Zip code


Address

S1W17, Chuo-ku, Sapporo, 060-8556, Japan

TEL

011-611-2111(ext.3254)

Email

yasushis@sapmed.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yasushis Sato

Organization

Sapporo Medical University School of Medicine

Division name

Dept. of Internal Medicine(4)

Zip code


Address

1W17, Chuo-ku, Sapporo, 060-8556, Japan

TEL

011-611-2111(ext.3254)

Homepage URL


Email

yasushis@sapmed.ac.jp


Sponsor or person

Institute

Sapporo Medical University School of Medicine
Dept. of Internal Medicine(4)

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

2010 Year 02 Month 06 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

Open public recruiting

Date of protocol fixation

2009 Year 09 Month 18 Day

Date of IRB


Anticipated trial start date

2009 Year 11 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

2010 Year 02 Month 06 Day

Last modified on

2014 Year 08 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003809


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name