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)
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
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
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
