UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A feasibility study of Pemetrexed/Bevacizumab in elderly patients with advanced non-small cell lung cancer (TORG1015)
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Tetsu Shinkai
Organization	National Hospital Organization Shikoku Cancer Center
Division name	Department of thoracic oncology
Address	160 Kou Minamiumemoto-machi, Matsuyama, Ehime
TEL	089-999-1111
Email

Public contact
Name of contact person	Naoyuki Nogami, Toshiyuki Kozuki
Organization	National Hospital Organization Shikoku Cancer Center
Division name	Department of thoracic oncology
Address	160 Kou Minamiumemoto-machi, Matsuyama, Ehime
TEL
Homepage URL
Email

Sponsor
Institute	Thoracic Oncology Research Group
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 09 Month 16 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	http://www.biomedcentral.com/1471-2407/16/306/abstract
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005112