UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II study for efficacy and safety of nab-paclitaxel and carboplatin combination chemotherapy for Previously untreated advanced non-small cell lung cancer
Title of the study (Brief title)	Phase II study of nab-PTX/CBDCA for elderly advanced NSCLC
Region	Japan

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

Objectives
Narrative objectives1	To investigate for efficacy and toxicities of nab-paclitaxel and carboplatin combination chemotherapy for elderly (more than 70 years-old) untreated advanced non-small cell lung cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	response rate
Key secondary outcomes	progression-free survival, overall survival, toxicities, number of 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	carboplatin at the dose of area under curve 5 (day 1) and nab-paclitaxel at the dose of 100mg/m^2 (day 1, 8, 16) every 3 weeks, upto 6 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

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) Definitively diagnosed with having previously untreated advanced non-small cell lung cancer by the specimens histologically or cytologically. 2) Age of more than 70 years-old 3) With adequate organ function of bone marrow reserve, liver, and kidney. (1) PS 0-1 (2) neutrophil count => 1,500/mm^3 (3) platelet => 100,000/mm^3 (4) hemoglobin => 9.0g/dL (5) AST/ALT < 2.5 times less than ULN (6) T.Bil <= 1.5mg/dL (7) serum creatinine <= 1.5mg/dL (8) ECG: without clinically problematic abnorbomalities (9) Peripheral neuropathy <= Grade 1 (10) SpO2 (room air) more than 92% 4) With the status of below previous treatment at the time of beginning of chemotherapy. (1) Radiotherapy: irradiated extrathoracic lesion: more than two weeks from the date of last irradiation (2) Surgical procedure, including pleurodesis or pleural drainage * more than 8 weeks with lobectomy * more than 4 weeks without lobectomy, including exploratory thoracotomy * more than 2 weeks after completing procedure (pleurodesis or pleural drainage) 5) With expected prognosis more than 12 weeks 6) With written informed consent
Key exclusion criteria	1) The age of less than 70 years-old 2) Previously treated with chemotherapy 3) With uncontrolled brain metastasis 4) With clinically active infection 5) With severe complication (cardiac diseases, interstitial pneumonia, uncontrolled hypertension or diabetes) 6) With uncontrolled pleural effusion 7) With active other organ cancer 8) With the history of severe drug allergy 9) With the history of hypersensivity for paclitaxel, albumin-containing agents 10) With the history of hypersensitivity for platinum agents 11) With uncontrolled digestive ulcer 12) Any patients judged by the investigator to be unfit to participate in the study
Target sample size	38

Research contact person
Name of lead principal investigator	Hosomi, Yukio
Organization	Tokyo Metropolitan Cancer and Infection diseases Center Komagome Hospital
Division name	Department of Thoracic Oncology and Respiratory Medicine
Address	3-18-22, Honkomagome, Bunkyo Tokyo
TEL	03-3823-2101
Email	yhosomi@cick.jp

Public contact
Name of contact person	Okuma, Yusuke
Organization	Tokyo Metropolitan Cancer and Infection diseases Center Komagome Hospital
Division name	Department of Thoracic Oncology and Respiratory Medicine
Address	3-18-22, Honkomagome, Bunkyo Tokyo
TEL	03-3823-2101
Homepage URL
Email	y-okuma@cick.jp

Sponsor
Institute	Tokyo Metropolitan Cancer and Infection diseases Center Komagome Hospital
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	Tokyo Metropolitan Cancer and Infection diseases Center Komagome Hospital
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	2013 Year 05 Month 16 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2013 Year 05 Month 01 Day
Anticipated trial start date	2013 Year 05 Month 01 Day
Last follow-up date	2016 Year 02 Month 29 Day
Date of closure to data entry	2016 Year 02 Month 29 Day
Date trial data considered complete	2016 Year 02 Month 29 Day
Date analysis concluded	2016 Year 02 Month 29 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	http://link.springer.com/article/10.1007%2Fs00280-016-3092-9
Results	RESULTS: The study was interrupted early because of two treatment-related deaths and 1 life-threatening severe adverse event; therefore, only 10 patients (median age, 77 years; range 71-82 years) were enrolled. The primary end point of the objective response was 50 % for the 10 patients analyzed. Progression-free survival was 4.48 months [95 % confidence interval (CI) 0.36-6.44], and overall survival was 7.89 months (95 % CI 0.36-26.88). Common treatment-related adverse events higher than grade 2 included decreased neutrophil counts, anemia, decreased albumin, anorexia, and peripheral neuropathy. Regarding severe adverse events, two patients had febrile neutropenia and lung infection. Two patients died, and one patient had febrile neutropenia with intubation during the first cycle. The Data and Safety Monitoring Committee therefore recommended interruption of patient enrollment. CONCLUSION: Nab-paclitaxel plus carboplatin, without dose reduction, is indicated to be toxic and intolerable as first-line chemotherapy in elderly Japanese patients with advanced NSCLC. Care must be taken when extrapolating the results of a clinical trial into clinical practice, particularly when the resulting subgroup analysis is of elderly patients because this patient group is composed of a heterogeneous population.
Other related information	A phase II study of nanoparticle albumin-bound paclitaxel plus carboplatin as the first-line therapy in elderly patients with previously untreated advanced non-small cell lung cancer. Cancer Chemother Pharmacol. 2016 Jun 23. DOI: 10.1007/s00280-016-3092-9

Management information
Registered date	2013 Year 05 Month 16 Day
Last modified on	2016 Year 07 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012540