UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A phase II trial of cisplatin, docetaxel and bevacizumab followed by maintenance pemetrexed and bevacizumab in metastatic non-small-cell lung cancer
Title of the study (Brief title)	A phase II trial of cisplatin, docetaxel and bevacizumab followed by maintenance pemetrexed and bevacizumab in metastatic non-small-cell lung cancer
Region	Japan

Condition
Condition	non-small-cell lung cancer
Classification by specialty	Medicine in general Pneumology Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and toxicity of the triplet chemotherapy (cisplatin, docetaxel and bevacizumab) and maintenance chemotherapy (pemetrexed and bevacizumab)
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	PFS
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	cisplatin, docetaxel, bevacizumab, and pemetrexed
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	Not applicable
Age-upper limit	75 years-old >=
Gender	Male and Female
Key inclusion criteria	pathologically proven non-squamous cell carcinoma stage IV or ineligibility as candidates for curative treatment aged 75 or less measurable tumor sites no prior chemotherapy no prior systemic anticancer therapy including palliative brain or bone irradiation within 2 weeks of proposed entry to this trial no prior thoracic irradiation to primary tumor no prior operation within 4 weeks of proposed entry to this trial ECOG PS of 0 to 1 appropriate organ function acquisition of written informed consent
Key exclusion criteria	pts with active co-morbidities including severe conditions of heart diseases, gastric ulcers, infections, uncontrollable diabetes, psychlogicai diseases, hypertension, active interstitial and hearing loss. pts with hemoptysis with 2.5mL or more bleeding tendency pts with radiological findings of tumor invasion to major vessels (i.e. aorta) and cavity lesion pts with bleeding tendency pts who need continuous use of antithrombotic agents pts with active other cancers that was detected within the past 5 years pts with massive pleural and cardiac effusion and ascites that need to be immediately treated pregnant women pts who need emergent irradiation
Target sample size	40

Research contact person
Name of lead principal investigator	Katsuyuki Kiura
Organization	Okayama University Hospital
Division name	Department of Respiratory Medicine
Address	2-5-1, Shikatacho, Okayama, Japan
TEL	0862237151
Email	khotta@md.okayama-u.ac.jp

Public contact
Name of contact person	Katsuyuki Hotta
Organization	Okayama University Hospital
Division name	Department of Respiratory Medicine
Address	2-5-1, Shikatacho, Okayama, Japan
TEL	0862237151
Homepage URL
Email	khotta@md.okayama-u.ac.jp

Sponsor
Institute	Okayama Lung Cancer Study Group
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information	2010 Year 08 Month 30 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2010 Year 02 Month 22 Day
Anticipated trial start date	2010 Year 08 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	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2010 Year 08 Month 30 Day
Last modified on	2018 Year 03 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000004957