UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004240
Receipt number R000005099
Scientific Title A feasibility study of Docetaxel/Bevacizumab in elderly patients with advanced non-small cell lung cancer (TORG1014)
Date of disclosure of the study information 2010/09/24
Last modified on 2014/03/22 09:01:27

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Basic information

Public title

A feasibility study of Docetaxel/Bevacizumab in elderly patients with advanced non-small cell lung cancer (TORG1014)

Acronym

TORG1014

Scientific Title

A feasibility study of Docetaxel/Bevacizumab in elderly patients with advanced non-small cell lung cancer (TORG1014)

Scientific Title:Acronym

TORG1014

Region

Japan


Condition

Condition

Non-small cell lung cancer

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate recommended dose of Docetaxel and Bevacizumab combination therapy in elderly patients with non-small cell lung cancer.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Toxicity

Key secondary outcomes

Response rate,
Progression-free survival,
Overall survival,
Completion proportion of 3 cycles


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Bevacizumab plus Docetaxel

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



Eligibility

Age-lower limit

70 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1. Patients with pathologically proven non-squamous non-small cell lung cancer.
2. Patients with StageIIIB/IV or recurrence non-small cell lung cancer and were not a candidate for curative radiotherapy.
3. Patients previously treated with chemotherapy (except EGFR-TKI for first line therapy and UFT for postoperative adjuvant chemotherapy).
4. Performance Status (ECOG) 0-1
5. Patients who have at least one or more measurable lesion by RECIST(Version1.1).
6. Patients aged 70 years or older.
7. Ineligible for standard cisplatin(bolus infusion)-containing combination chemotherapy.
8. Sufficient function of main organ and bone marrow filled the following criteria
Leukocyte counts >= 4,000/mm3
Neutrophil counts >= 2,000/mm3
Platelets >= 100,000/mm3
Hemoglobin concentration >= 9.5 g/dL
AST and ALT, x2 of upper limit of normal (ULN) or less
Total bilirubin, 1.5mg/dL or less
Serum creatinin, x 1.2mg/dL or less
SpO2 93% or above
Proteinuria, 1+ or less
9. interval
(1) radiation therapy
More than 2 weeks after the last radiation therapy for nonthoracic region.
(2) operation
More than 8 weeks after the last operation with pulmonary resection.
More than 4 weeks after the last operation without pulmonary resection.
More than 2 weeks after the last pleurodesis or thoracic cavity drainage.
10. Patients providing written informed consent.

Key exclusion criteria

1. Patients with brain metastasis.
2. Patients with current or previous hemoptysis.
3. Patients treated with radiation therapy for thoracic region.
4. Patients with active severe infections.
5. Patients who have fever of over 38 degrees.
6. Patients with serious complication (cardiac affection, interstitial pneumonia, uncontrollable hypertension, or uncontrollable diabetes mellitus, etc.)
7. Patients with massive ascites, pleural or pericardial effusion.
8. Patients with concomitant malignancy.
9. Patients with history of drug allergies.
10. Patients with uncontrollable gastrointestinal ulceration.
11. Patients with current or previous (within one year) history of gastrointestinal perforation.
12. Patients treated with anticoagulation therapy
13. Inappropriate patients for this study judged by the physicians

Target sample size

12


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yukio Hosomi

Organization

Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital

Division name

Division of Respiratory Medicine

Zip code


Address

18-22, Honkomagome 3cho-me, Bunkyo-ku, Tokyo

TEL

03-3823-2101

Email

yhosomi@cick.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yukio Hosomi

Organization

Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital

Division name

Division of Respiratory Medicine

Zip code


Address

18-22, Honkomagome 3cho-me, Bunkyo-ku, Tokyo

TEL

03-3823-2101

Homepage URL

http://www.torg.or.jp/testing.html

Email

yhosomi@cick.jp


Sponsor or person

Institute

Thoracic Oncology Research Group(TORG)

Institute

Department

Personal name



Funding Source

Organization

Thoracic Oncology Research Group(TORG)

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



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

2010 Year 09 Month 24 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

Completed

Date of protocol fixation

2010 Year 09 Month 21 Day

Date of IRB


Anticipated trial start date

2010 Year 09 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2010 Year 09 Month 21 Day

Last modified on

2014 Year 03 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005099


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name