UMIN-CTR Clinical Trial

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

Previously treated non-small cell lung cancer

Classification by specialty

Pneumology

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

YES

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

Primary outcomes

Progression free survival

Key secondary outcomes

Overall survival,response, safety, and analysis of EGFR mutation using tumor sumples

Study type

Interventional

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

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

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

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

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

Institute

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

Institute

Department

Personal name

Organization

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

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2009

Year

08

Month

11

Day

URL releasing protocol

http://www.csecr.jp/DELTApage.html

Publication of results

Published

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

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 related 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