UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013316
Receipt number R000015535
Scientific Title Randomized phase II trial evaluating the efficacy and safety of standard care +/- continuous gefitinib treatment beyond progression in patients with advanced NSCLC after 1st line treatment with gefitinib(TORG1019)
Date of disclosure of the study information 2014/03/03
Last modified on 2014/11/11 13:15:47

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Basic information

Public title

Randomized phase II trial evaluating the efficacy and safety of standard care +/- continuous gefitinib treatment beyond progression in patients with advanced NSCLC after 1st line treatment with gefitinib(TORG1019)

Acronym

Continuous gefitinib beyond PD study(TORG1319)

Scientific Title

Randomized phase II trial evaluating the efficacy and safety of standard care +/- continuous gefitinib treatment beyond progression in patients with advanced NSCLC after 1st line treatment with gefitinib(TORG1019)

Scientific Title:Acronym

Continuous gefitinib beyond PD study(TORG1319)

Region

Japan


Condition

Condition

EGFR positive non-sqamous 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 and the safety of chemotherapy + beyond PD gefitinib with those of chemotherapy alone

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

2 years survival rate after randomization

Key secondary outcomes

Frequency of the flare, overall survival, safety, QOL, response rates of 2nd and 3rd line therapies , and progression-free survivals of 2nd and 3rd line therapies


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

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

1st line: gefitinib, 2nd line: gefitinib + CDDP or CBDCA + pemetrexed, 3rd line: gefitinib + docetaxel , 4th to 6th line: gefitinib + paclitaxel, gemcitabine, or TS-1

Interventions/Control_2

1st line: gefitinib, 2nd line: CDDP or CBDCA + pemetrexed, 3rd line: docetaxel, 4th to 6th line: any treatment

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

74 years-old >=

Gender

Male and Female

Key inclusion criteria

1) Histologically or cytologically confirmed non-squamous, non-small cell lung cancer with active EGFR mutations
2)-1. Stage III/ IV patients with postoperative recurrence or non-curative status by radiotherapy
2)-2. Acquired resistance for 1st line gefitinib treatment
3) No prior chemotherapy
4) ECOG performance status 0-1
5) Aged 20 to 74 years old.
6) Adequate organ function
7) Estimated life expectancy at least 3 months
8) at least one measurable lesion
9) Written informed consent by patient

Key exclusion criteria

1) Treated by other molecular targeted drug or cytotoxic agent
2) Prior radiation for primary lesions
3) History of steroid therapy for radiation pneumonitis
4) Patients with symptomatic brain metastasis
5) Interstitial pneumonitis or pulmonary fibrosis detectable on CT scan
6) Patient with pleural effusion, pericardial effusion, ascites or superior vena cave
7) With active infection or other serious medical complications
8) Clinically significant allergy
9) With active double cancer
10) Pregnancy or lactating patients
11) Judged to be not suitable by the attending physician

Target sample size

70


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kenji Eguchi

Organization

Teikyo university school of medicine

Division name

Division of Medical oncology

Zip code


Address

2-11-1, Kaga, Itabashi-ku, Tokyo, 173-8606

TEL

(03)3964-1211

Email

keguchi@med.teikyo-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Nobuhiko Seki

Organization

Teikyo university school of medicine

Division name

Division of Medical oncology

Zip code


Address

2-11-1, Kaga, Itabashi-ku, Tokyo, 173-8606

TEL

03-3964-1211

Homepage URL

http://www.torg.or.jp

Email

nseki@med.teikyo-u.ac.jp


Sponsor or person

Institute

Thoracic Oncology Research Group

Institute

Department

Personal name



Funding Source

Organization

Thoracic Oncology Research Group

Organization

Division

Category of Funding Organization

Non profit foundation

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

2014 Year 03 Month 03 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

Terminated

Date of protocol fixation

2013 Year 11 Month 27 Day

Date of IRB


Anticipated trial start date

2014 Year 03 Month 10 Day

Last follow-up date

2018 Year 11 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 03 Month 03 Day

Last modified on

2014 Year 11 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015535


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name