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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000003141
Receipt No. 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

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

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
URL(English) https://upload.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


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