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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002314
Receipt No. 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

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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
Email 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
Email asami@kch.hosp.go.jp

Sponsor
Institute National Hospital Organization Headquarters Center for Support and Education of Clinical Research
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002826

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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