UMIN-CTR Clinical Trial

Basic information
Public title	Phase I trial of biweekly Carboplatin plus nab-Paclitaxel with concurrent thoracic radiotherapy in patients with locally advanced non-small cell lung cancer
Acronym	Phase I trial of biweekly CBDCA + nab-PTX +TRT for LA-NSCLC
Scientific Title	Phase I trial of biweekly Carboplatin plus nab-Paclitaxel with concurrent thoracic radiotherapy in patients with locally advanced non-small cell lung cancer
Scientific Title:Acronym	Phase I trial of biweekly CBDCA + nab-PTX +TRT for LA-NSCLC
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 the dose limiting toxicity (DLT), estimate maximum tolerated dose (MTD) and determine recommend dose (RD) of biweekly Carboplatin plus nab-Paclitaxel with concurrent thoracic radiotherapy in patients with locally advanced non-small cell lung cancer. And also we evaluate the efficacy of biweekly Carboplatin plus nab-Paclitaxel with concurrent thoracic radiotherapy.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase I

Assessment
Primary outcomes	Incidence of dose limiting toxicities at each dose level
Key secondary outcomes	Incidence and Severity of Adverse Events Treatment completion rate Response Rate 2-year survival rate Progression-free Survival Overall Survival

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	Radiotherapy: 2Gy, 5fr/week 6weeks, Total 60Gy Carboplatin: AUC 4, day 1, 15, 29 nab-Paclitaxel: dose of each level, day 1, 15, 29 Level 1: 60 mg/m2 Level 2: 80 mg/m2 Level 3: 100 mg/m2
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) Histologically or cytologically confirmed non-small cell lung cancer. 2) Clinical Stage IIIA or IIIB. 3) No prior therapy for NSCLC. 4) V20 is 35% or less by CT simulation before enrollment. 5) At least one measurable lesion. 6) ECOG Performance status of 0-1. 7) Age of 20 to 74 years. 8) Sufficient major organ function as bellow. *White blood cell count >= 4,000 /mm3 *Neutrophil count >= 2,000 /mm3 *Platelet count >= 100,000 /mm3 *Hemoglobin >= 9.5 g/dL *total bilirubin <= 1.5 mg/dL *AST <= 100 IU/L *ALT <= 100 IU/L *Serum creatinine <= 1.5 mg/dL *PaO2 >= 70 Torr or more 9) Written informed consent.
Key exclusion criteria	1) Patients with T3N1. 2) Superior vena cava syndrome. 3) Contralateral hilar lymph node metastasis, malignant plueral, pericardial effusion, carcinomatous lymphangiosis. 4) Active double cancer. 5) Active infections requiring systemic treatment. 6) Severe concurrent disease (Pulmonary fibrosis or interstitial pneumonia, renal failure, hepatic failure, cerebrovascular disease, ischemic heart disease requiring treatment, arrhythmia, cardiac infarction within 6 months before enrollment, hemorrhagic peptic ulcer, poorly controlled diabetes). 7) Grade 2 or higher peripheral neuropathy. 8) Positive HBs antigen and/or HCV antibody. 9) History of Severe drug allergies. 10) Pregnant females, possibly pregnant females, females wishing to become pregnant and nursing mothers. Males that are currently attempting to produce a pregnancy. 11) Physician concludes that the patient's participation in this trial is inappropriate.
Target sample size	18

Research contact person
Name of lead principal investigator	1st name Yukihiro Middle name Last name Hasegawa
Organization	Aomori Prefectural Central Hospital
Division name	Department of Respiratory Medicine
Zip code	030-0913
Address	2-1-1 Higashi Tsukurimichi, Aomori 030-8553, Japan
TEL	017-726-8111
Email	yukihiro_hasegawa@med.pref.aomori.jp

Public contact
Name of contact person	1st name Yukihiro Middle name Last name Hasegawa
Organization	Aomori Prefectural Central Hospital
Division name	Department of Respiratory Medicine
Zip code	030-0913
Address	2-1-1 Higashi Tsukurimichi, Aomori 030-8553
TEL	017-726-8111
Homepage URL
Email	yukihiro_hasegawa@med.pref.aomori.jp

Sponsor
Institute	Aomori Prefectural Central Hospital
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)

IRB Contact (For public release)
Organization	Aomori Prefectural Central Hospital
Address	2-1-1 Higashi Tsukurimichi, Aomori 030-8553
Tel	017-726-8111
Email	kenbyo@pref.aomori.lg.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	青森県立中央病院（青森県）

Other administrative information
Date of disclosure of the study information	2013 Year 05 Month 01 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 04 Month 12 Day
Date of IRB	2013 Year 10 Month 01 Day
Anticipated trial start date	2013 Year 06 Month 01 Day
Last follow-up date	2019 Year 02 Month 12 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2013 Year 04 Month 12 Day
Last modified on	2021 Year 04 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012231