UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004263
Receipt number R000005112
Scientific Title A feasibility study of Pemetrexed/Bevacizumab in elderly patients with advanced non-small cell lung cancer (TORG1015)
Date of disclosure of the study information 2010/09/25
Last modified on 2016/05/13 00:22:34

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Basic information

Public title

A feasibility study of Pemetrexed/Bevacizumab in elderly patients with advanced non-small cell lung cancer (TORG1015)

Acronym

TORG1015

Scientific Title

A feasibility study of Pemetrexed/Bevacizumab in elderly patients with advanced non-small cell lung cancer (TORG1015)

Scientific Title:Acronym

TORG1015

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 Pemetrexed 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 Pemetrexed administrated on day 1 every 3 weeks

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, x 2.5 of upper limit of normal (ULN) or less
Total bilirubin, 1.5mg/dL or less
Serum creatinin, 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 Tetsu Shinkai

Organization

National Hospital Organization Shikoku Cancer Center

Division name

Department of thoracic oncology

Zip code


Address

160 Kou Minamiumemoto-machi, Matsuyama, Ehime

TEL

089-999-1111

Email



Public contact

Name of contact person

1st name
Middle name
Last name Naoyuki Nogami, Toshiyuki Kozuki

Organization

National Hospital Organization Shikoku Cancer Center

Division name

Department of thoracic oncology

Zip code


Address

160 Kou Minamiumemoto-machi, Matsuyama, Ehime

TEL


Homepage URL


Email



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

独立行政法人国立病院機構 四国がんセンター(愛媛県)
藤沢市民病院(神奈川県)
千葉大学医学部附属病院 (千葉県)
茨城県立中央病院(茨城県)
日本医科大学千葉北総病院(千葉県)
神奈川県立循環器呼吸器病センター(神奈川県)
神戸赤十字病院(兵庫県)


Other administrative information

Date of disclosure of the study information

2010 Year 09 Month 25 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

http://www.biomedcentral.com/1471-2407/16/306/abstract

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 16 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 24 Day

Last modified on

2016 Year 05 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005112


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name