UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002314 |
|---|---|
| Receipt number | R000002826 |
| Scientific Title | Randomized phase III trial of erlotinib versus docetaxel for patients with previously treated advanced non-small cell lung cancer |
| Date of disclosure of the study information | 2009/08/11 |
| Last modified on | 2014/03/13 13:56:08 |
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Basic information
Public title
Randomized phase III trial of erlotinib versus docetaxel for patients with previously treated advanced non-small cell lung cancer
Acronym
Docetaxel and Erlotinib Lung cancer trial (DELTA)
Scientific Title
Randomized phase III trial of erlotinib versus docetaxel for patients with previously treated advanced non-small cell lung cancer
Scientific Title:Acronym
Docetaxel and Erlotinib Lung cancer trial (DELTA)
Region
| Japan |
Condition
Condition
Previously treated non-small cell lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To compare the efficacy of erlotinib with docetaxel in previously treated non-small cell lung cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
Progression free survival
Key secondary outcomes
Overall survival,response, safety, and analysis of EGFR mutation using tumor sumples
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
A: Experimental arm
Erlotinib monotherapy
Interventions/Control_2
B: Reference arm
Docetaxel monotherapy
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Patients with non-small cell lung cancer of stage IIIB or IV, which was pathologically proven and who are not candidates for radiotherapy with a curative intent.
2)Patients who heve previously treated one or two chemotherapy.
*Prior chemotherapy consisting of platinum agents in at least one regimen.
*Adjuvant chemotherapy, consisting of platinum agent, is considered as one regimen of chemotherapy.
3)No prior drug therapy targeting EGFR-TKIs.
4)No prior chemotherapy, consisting of docetaxel.
5)Patients with evaluable or measurable (
by CT or MRI) disease.
6)Age eligible for study: 20 years and above
7)ECOG PS 0-2
8)Sufficient organ function
WBC>=3,500/mm3
Hb>=9.0g/dl
Plt >=100,000/mm3
Neutrophil>=1,500/mm3
GOT/GPT <=100IU/L
T-bil=<1.5mg/dl
Cr. =<1.5mg/dL
SpO2>=92%
9)Patients are expected to live over 12 weeks.
10)Written informed consent
Key exclusion criteria
1)History of obvious distributed interstitial pneumonia or pulmonary fibrosis detected by chest CT (Patients with radiation peumonitis limited to radiation field are eligible)
2)History of obvious drug induced interstitial pneumonia or pneumoconiosis
3)History of symptomatic brain metastases. Patients with brain metastases are eligible, if thier brain metastases are controlled by radiotherapy or drug therapy.
5)History of severe drug allergy
6)History of poorly controlled pleural effusion, pericardial effusion or ascites necessitating drainage
7)History of active infection or other serious disease condition (poorly controlled diabetes mellitus, poorly controlled cardiac disease, GI bleeding, cirrhosis, ileus, persistant watery diarrhea, etc)
8)History of active double cancer
9)History of active psychological disease.
10) History of pregnancy or lactation
11) Patients whose participation in the trial is judged to be inappropriate by the attending doctor
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomoya kawaguchi |
Organization
National Hospital Organization Kinki-chuo Chest Medical Center
Division name
Internal Medicine
Zip code
Address
1180 Nagasone, Kitaku, Sakai, Osaka, Japan
TEL
072-252-3021
t-kawaguchi@kch.hosp.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Asami |
Organization
National Hospital Organization Kinki-chuo Chest Medical Center
Division name
Internal Medicine
Zip code
Address
1180 Nagasone, Kitaku, Sakai, Osaka, Japan
TEL
072-252-3021
Homepage URL
asami@kch.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization Headquarters Center for Support and Education of Clinical Research
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization Headquarters Center for Support and Education of Clinical Research
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
| 2009 | Year | 08 | Month | 11 | Day |
Related information
URL releasing protocol
http://www.csecr.jp/DELTApage.html
Publication of results
Published
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
| 2009 | Year | 07 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
| 2013 | Year | 01 | Month | 17 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 08 | Month | 09 | Day |
Last modified on
| 2014 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002826
