UMIN-CTR Clinical Trial

Public title

Single Arm Phase II Trial of Nitroglycerin Plus Docetaxel in Elderly Untreated Stage IIIB/IV Non-small-cell Lung Cancer

Acronym

Single Arm Phase II Trial of Nitroglycerin Plus Docetaxel in Elderly Untreated Stage IIIB/IV Non-small-cell Lung Cancer (TUTRCDC003)

Scientific Title

Single Arm Phase II Trial of Nitroglycerin Plus Docetaxel in Elderly Untreated Stage IIIB/IV Non-small-cell Lung Cancer

Scientific Title:Acronym

Single Arm Phase II Trial of Nitroglycerin Plus Docetaxel in Elderly Untreated Stage IIIB/IV Non-small-cell Lung Cancer (TUTRCDC003)

Region

Japan

Condition

Non-small-cell lung cancer

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To study the effects and toxicity of nitroglycerin plus docetaxel in elderly patients with advanced non-small cell lung cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Primary outcomes

(1) response rate

Key secondary outcomes

(1) Progression free survival
(2) Frequency of toxicities
(3) Overall survival
(4) Change in plasma vascular endothelial growth factor level during nitroglycerin treatment for 3 days before chemotherapy as an indicator for response to nitroglycerin plus docetaxel and cisplatin regimen

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -but assessor(s) are blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Transdermally applied nitroglycerin (10 mg/day) for consecutive 5 days between 3 days before start of chemotherapy using 60 mg/m2 of docetaxel (D1) every 3 weeks and the day 2 of chemotherapy

Interventions/Control_2

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

70

years-old

<=

Age-upper limit

85

years-old

>

Gender

Male and Female

Key inclusion criteria

(a) The diagnosis of non-small cell lung cancer was confirmed with histological or cytological examination;
(b) Stage IIIB or stage IV;
(c) A measurable or evaluable tumor lesion according to WHO criteria;
(d) Good performance status: a performance status (PS) of 0-1 according to the Eastern Cooperative Oncology Group (ECOG) scale;
(e) Adequate hepatic function (serum bilirubin < 1.5 x LN, ALT, and AST < 2.5 x LN);
(f) Adequate hematologic function (neutrophil count > 2,000/&micro;L, hemoglobin > 9g/dL, platelet count> 100,000/&micro;L);
(g) Adequate cardiac function (cardiothoracic ratio< 60%);
(h) Informed consent to receive chemotherapy and attend this study was obtained;
(i) Scheduled treatment with chemotherapy and without radiotherapy;
(j) Systolic blood pressure: equal to or more than 90mmHg
(k) Prognosis: equal to or more than 3 months

Key exclusion criteria

(a) No treatment with a vasodilator such as calcium channel blockers
(b) No prior chemotherapy or radiotherapy;
(c) Without uncontrollable brain metastasis;
(d) No ischemic heart disease;
(e) Without active interstitial pneumonitis
(f) Without uncontrollable massive pleural effusion or pericardial effusion
(g) Without pregnancy or nurse
(h) No enrollment in another interventional study

Target sample size

40

Name of lead principal investigator

1st name
Middle name
Last name	Hiroyasu Yasuda

Organization

Tohoku University Translational Research Center

Division name

Department of clinical application

Zip code

Address

1-1 Seiryo-machi, Aoba-ku, Sendai, 980-8574, Japan

TEL

022-717-7122

Email

Name of contact person

1st name
Middle name
Last name	Hiroyasu Yasuda

Organization

Tohoku University Translational Research Center

Division name

Department of clinical application

Zip code

Address

1-1 Seiryo-machi, Aoba-ku, Sendai, 980-8574, Japan

TEL

022-717-7122

Homepage URL

Email

yasuda@trc.med.tohoku.ac.jp

Institute

Tohoku University Translational Research Center

Institute

Department

Personal name

Organization

Ministry of Education, Science and Culture (19689018, and 17790524) of the Japanese government, and The Kanae Foundation for the Promotion of Medical Science

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan

Co-sponsor

Tohoku University Hospital, Shinshu University Hospital, Shiga Medical Center for Adults, Kyoto University Hospital, Osaka Police Hospital, Takatsuki Red Cross Hospital

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

03

Month

31

Day

URL releasing protocol

Publication of results

Unpublished

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

Date of protocol fixation

2009

Year

02

Month

16

Day

Date of IRB

Anticipated trial start date

2009

Year

03

Month

01

Day

Last follow-up date

2013

Year

03

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2009

Year

03

Month

30

Day

Last modified on

2010

Year

04

Month

02

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002194