UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000310 |
|---|---|
| Receipt number | R000000400 |
| Scientific Title | Docetaxel in combination with either cisplatin (DC) or gemcitabine (DG) in unresectable non-small sell lung carcinoma (NSCLC) |
| Date of disclosure of the study information | 2006/01/23 |
| Last modified on | 2007/03/26 11:26:03 |
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Basic information
Public title
Docetaxel in combination with either cisplatin (DC) or gemcitabine (DG) in unresectable non-small sell lung carcinoma (NSCLC)
Acronym
Docetaxel in combination with either cisplatin (DC) or gemcitabine (DG) in unresectable non-small sell lung carcinoma (NSCLC)
Scientific Title
Docetaxel in combination with either cisplatin (DC) or gemcitabine (DG) in unresectable non-small sell lung carcinoma (NSCLC)
Scientific Title:Acronym
Docetaxel in combination with either cisplatin (DC) or gemcitabine (DG) in unresectable non-small sell lung carcinoma (NSCLC)
Region
| Japan |
Condition
Condition
Non-small sell lung carcinoma (NSCLC)
Classification by specialty
| Pneumology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficary of the Docetaxel + Gemcitabin (DG) regimen, and to determine if it is not inferior to the Docetaxel + Cisplatin (DC) regimen.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Response rate
Key secondary outcomes
Survival (1-year survival rate)
Toxicity
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The DC arm:
Doc(60mg/m2) day1
CDDP(80mg/m2) day1
Every 3 to 4 weeks
Interventions/Control_2
The DG arm:
Doc(60mg/m2) day8
Gem(800mg/m2) day1,8
Every 3 to 4 weeks
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Histologically or cytologically proven NSCLC
2.Stage IIIB or IV
3.Measurable lesions by RECIST
4.No prior therapy
5.PS(ECOG) 0 or 1
6.Expected survival of more than 3 months
7.Preserved organ functions
8.Age of 20 to 75-year old
9.Written IC
Key exclusion criteria
1.Proven or suspected infections diseases
2.Interstitial pneumonia (pulmonary fibrosis) manifested with chest radiogram and symptoms
3.Uncontrolable complications of heart, liver, DM, bleeding, etc.
4.Peripheral neuropathy of grade 2 or severer
5.Pleural fluid requiring treatment
6.Pericardial fluid
7.Symptomatic brain metastasis
8.Active concomitant malignancy
9.Pregnancy, breast feeding or wish of future bearing
10.History of drug allergy
11.Myocardial infarction within 3 months
12.Requirement of emergency radiotherapy
13.Other conditions not suitable for this study
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hisanobu Niitani |
Organization
The Tokyo cooperative oncology group
Division name
Chief director
Zip code
Address
1-23-2 Hamamatsu-cho Minato-ku Tokyo Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
The Tokyo cooperative oncology group
Division name
Secretariat
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
The Tokyo cooperative oncology group
Institute
Department
Personal name
Funding Source
Organization
The Tokyo cooperative oncology group
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
| 2006 | Year | 01 | Month | 23 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.jto.org/
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
| 2002 | Year | 02 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2002 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2004 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
| 2004 | Year | 09 | Month | 01 | Day |
Date trial data considered complete
| 2004 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2004 | Year | 10 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2006 | Year | 01 | Month | 23 | Day |
Last modified on
| 2007 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000400
