UMIN-CTR Clinical Trial

Basic information
Public title	Feasibility study of adjuvant chemotherapy with nab-paclitaxel and carboplatin in patients with completely resected pathological IB squamous cell lung cancer, II and IIIA non-small cell lung cancer
Acronym	Feasibility study of adjuvant nab-PTX/CBDCA for StageIB SqLC, II and IIIA NSCLC
Scientific Title	Feasibility study of adjuvant chemotherapy with nab-paclitaxel and carboplatin in patients with completely resected pathological IB squamous cell lung cancer, II and IIIA non-small cell lung cancer
Scientific Title:Acronym	Feasibility study of adjuvant nab-PTX/CBDCA for StageIB SqLC, II and IIIA NSCLC
Region	Japan

Condition
Condition	Non-small cell lung cancer
Classification by specialty	Chest surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to evaluate the feasibility of Nab-PTX plus CBDCA as adjuvant chemotherapy in patients with completely resected pathological IB squamous cell lung cancer, II and IIIA non-small cell lung cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The completion rate
Key secondary outcomes	toxicities, disease-free survival, overall survival, recurrence type

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	Nab-paclitaxel at the dose of 100mg/m2 (day 1, 8, 15) and carboplatin at the dose of area under curve 5 (day 1) are administered every 4 weeks and repeated 4 course.
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	1) Pathologically proven non-small cell lung cancer, except for low-malignant potential tumor such as mucoepidermoid carcinoma or adenoid cystic carcinoma, and large cell neuroendocrine carcinoma. 2) Pathological stage IB squamous cell lung cancer or stage II, IIIA non-small cell lung cancer 3) With complete resection 4) At least lobectomy (tracheobronchoplasty is permitted) 5) LN dissection (ND2a) or Elective Lymph Node Dissection 6) No prior anti-cancer treatment for thoracic malignancy except for this operation 7) ECOG PS 0-1 8) More than 20 years of age, under 75 years of age 9) Adequate organ function *Neutrophil count => 1,500/&micro;L *Platelet => 100,000/&micro;L *Hemoglobin => 9.0g/dL *AST/ALT < 2.5 times less than ULN *T.Bill <= 1.5mg/dL *Serum creatinine = 1.5mg/dL *ECG: without clinically problematic abnormalities 10) Within 10 weeks after surgery 11) With written informed consent
Key exclusion criteria	1) Not recovered from surgical complications 2) Active infection such as bacterial infection 3) Patients with interstitial pneumonitis or pulmonary fibrosis, as determined by chest CT 4) patients with myocardial infraction within 6 months 5) Patients with uncontrolled complications 6) With the history of hypersensitivity for nab-paclitaxel or CBDCA 7) Grade 2 or greater peripheral neuropathy 8) Active concomitant malignancy 9) Pregnant females, nursing mothers, possibly pregnant females, females wishing to become pregnant and Males that are currently attempting to produce a pregnancy 10) Other conditions not suitable for this study
Target sample size	45

Research contact person
Name of lead principal investigator	1st name Masayuki Middle name Last name Chida
Organization	Dokkyo Medical University
Division name	General Thoracic Surgery
Zip code	321-0293
Address	880 Kitakobayashi, Mibu-machi, Shimotsuga-gun, Tochigi
TEL	0282-86-1111
Email	chidaths@dokkyomed.ac.jp

Public contact
Name of contact person	1st name Masayuki Middle name Last name Chida
Organization	Dokkyo Medical University
Division name	Thoracic Surgery
Zip code	321-0293
Address	880 Kitakobayashi, Mibu-machi, Shimotsuga-gun, Tochigi
TEL	0282-86-1111
Homepage URL
Email	chidaths@dokkyomed.ac.jp

Sponsor
Institute	Dokkyo Medical University department of General thoracic surgery
Institute
Department

Funding Source
Organization	Dokkyo Medical University department of General thoracic surgery
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	Dokkyo Medical University
Address	880 Kitakobayashi, Mibu-machi, Shimotsuga-gun, Tochigi
Tel	0282-86-1111
Email	kobayasi@dokkyomed.ac.jp

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	獨協医科大学病院、自治医科大学付属病院

Other administrative information
Date of disclosure of the study information	2013 Year 12 Month 06 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	Open public recruiting
Date of protocol fixation	2013 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date	2013 Year 08 Month 01 Day
Last follow-up date	2018 Year 07 Month 31 Day
Date of closure to data entry	2018 Year 07 Month 31 Day
Date trial data considered complete	2018 Year 07 Month 31 Day
Date analysis concluded	2018 Year 07 Month 31 Day

Other
Other related information

Management information
Registered date	2013 Year 12 Month 06 Day
Last modified on	2020 Year 06 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014598