UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A phase I/II study of chemoradiation with use of carboplatin/nab-paclitaxel and concurrent radiotherapy for local advanced non-small cell lung cancer
Title of the study (Brief title)	A phase I/II study of chemoradiation with use of carboplatin/nab-paclitaxel and concurrent radiotherapy for local advanced non-small cell lung cancer
Region	Japan

Condition
Condition	Locally Advanced Non-Small Cell Lung Cancer
Classification by specialty	Pneumology Hematology and clinical oncology Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To determine the recommened doses and assess the efficacy and safety of Carboplatin plus nab-paclitaxel with concurrent Thoracic radiotherapy for locally advanced non-small cell lung cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase I,II

Assessment
Primary outcomes	phase I:determine the recommended dose phase II:2year survival rate
Key secondary outcomes	phase I:safety, response rate, progression free survival,overall survival, completion rate of chemoradiotherapy phase II:safety, response rate, progression free survival, overall survival, completion rate of chemoradiotherapy

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	Chemoradiotherapy: Combination of weekly carboplatin plus nab-paclitaxel with concurrent thoracic radiotherapy for a total 60Gy at 2Gy/fraction/day 5times weekly for 30 times. Consolidation therapy: Combination of carboplatin plus nab-paclitaxel every 3 weeks for 2 cycles.
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	20 years-old <=
Age-upper limit	75 years-old >
Gender	Male and Female
Key inclusion criteria	1)Cytologically or histologically documented NSCLC. 2)Untreated Stage IIIA or IIIB disease 3)Unresectable 4)V20 under 35 percent and an approval of a radiotherapist by CT simulation based on the restriction of this protcol before registration. 5)Have measurable lesion 6)Patient aged 20-74 years old at the time of consent. 7)Eastern Cooperative Oncology Group Performance Status(ECOG PS) 0 or 1 8)Organ functions are met for this study within two week before study entry. 9)With signed an informed consent document
Key exclusion criteria	1) With opposite hilar lymph nodes metastases 2) With interstitial lung disease, lung fibrosis 3) SVC syndrome 4) With active infection 5) With active double cancer 6) With other serious disease condition (bleeding, cardiac diseases, poorly controlled diabetes,etc.) 7) Clinically significant allergy 8) Patients with steroid treatment 9) Uncontrolled psychiatric disease 10) Pregnancy or lactating patients 11) Positive serum HBs antigen 12) Others
Target sample size	56

Research contact person
Name of lead principal investigator	Isamu Okamoto
Organization	kyushu University Hospital
Division name	Center for Clinical and Translational Research
Address	3-1-1, Maidashi, Higashi-ku, Fukuoka City
TEL	0926425378
Email	okamotoi@kokyu.med.kyushu-u.ac.jp

Public contact
Name of contact person	Yuko Kawano
Organization	Kyushu Univiersity Hospital
Division name	Respiratory Medicine
Address	3-1-1, Maidashi, Higashi-ku, Fukuoka City
TEL	0926425378
Homepage URL
Email	yukokawa@kokyu.med.kyushu-u.ac.jp

Sponsor
Institute	Research Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University
Institute
Department

Funding Source
Organization	Taiho Pharmamedical Ltd
Organization
Division
Category of Funding Organization	Profit organization
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	2013 Year 12 Month 27 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2013 Year 12 Month 27 Day
Anticipated trial start date	2013 Year 12 Month 27 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	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 12 Month 27 Day
Last modified on	2019 Year 01 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014671