UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Feasibility study of postoperative adjuvant carboplatin plus nab-paclitaxel for complete resected pathological stage II/IIIA non-small cell lung cancer
Title of the study (Brief title)	FASTnab
Region	Japan

Condition
Condition	completely resected pathological stage II/IIIA non-small cell lung cancer
Classification by specialty	Pneumology Endocrine surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To assess the feasibility of postoperative adjuvant carboplatin plus nab-paclitaxel for completely resected pathological stage II/IIIA non-small cell lung cancer
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Completion rate of scheduled adjuvant chemotherapy
Key secondary outcomes	Relative dose intensity, Disease-free survival, Overall survival, Incidence and grade of adverse events

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	carboplatin plus nab-paclitaxel
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 confirmed stage II/III non-small cell lung cancer 2, patients who underwent at least lobectomy with selective or systematic lymph nodal dissection 3, patients with complete resection of non-small cell lung cancer
Key exclusion criteria	1.History of drug hypersensitivity 2.Serious surgical or non-surgical complications 3.Active secondary cancer. 4.Patient to whom primary doctor judjed inadequate to register.
Target sample size	35

Research contact person
Name of lead principal investigator	Hisashi Saji
Organization	St. Marianna University School of Medicine
Division name	Chest Surgery
Address	2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa, 216-8511, Japan
TEL
Email

Public contact
Name of contact person
Organization	St. Marianna University School of Medicine
Division name	Chest Surgery
Address
TEL
Homepage URL
Email

Sponsor
Institute	St. Marianna University School of Medicine
Institute
Department

Funding Source
Organization	St. Marianna University School of Medicine
Organization
Division
Category of Funding 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 07 Month 19 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 06 Month 04 Day
Anticipated trial start date	2013 Year 07 Month 22 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	Published
URL releasing results	https://www.ncbi.nlm.nih.gov/pubmed/28538017
Results	Anticancer Drugs. 2017 Aug;28(7):795-800. doi: 10.1097/CAD.0000000000000512. Feasibility study of adjuvant chemotherapy with modified weekly nab-paclitaxel and carboplatin for completely resected non-small-cell lung cancer: FAST-nab. Saji H(1), Marushima H, Miyazawa T, Sakai H, Kimura H, Kurimoto N, Nakamura H. Author information: (1)Department of Chest Surgery, St Marianna University School of Medicine, Kawasaki, Japan. The aim of this study was to determine the feasibility of adjuvant administration of nab-paclitaxel (nab-P) plus carboplatin and for completely resected patients with stage IB, II, and IIIA non-small-cell lung cancer (NSCLC) (FAST-nab study, UMIN000011225). Twenty-nine eligible NSCLC patients received surgical resection for pathological stage IB, II, or IIIA, followed by postoperative adjuvant chemotherapy with modified 3-week cycles of either nab-P (100？mg/m) on days 1 and 8, followed by carboplatin area (area under the curve=6) on day 1. Twenty-two (75.9%) of the 29 patients enrolled completed four cycles of this regimen. The most common grade 3 or 4 adverse event experienced during the nab-P plus carboplatin was neutropenia (34.5%), followed by anemia (13.8%). No grade 3 or 4 nonhematologic adverse event was observed during this chemotherapy. The median time to disease recurrence survival was 21 (95% confidence interval: 16-26) months. The administration of modified nab-P plus carboplatin was considered an attractive alternative regimen that was safe and well tolerated as a postoperative adjuvant chemotherapy for completed resected NSCLC. DOI: 10.1097/CAD.0000000000000512 PMID: 28538017
Other related information

Management information
Registered date	2013 Year 07 Month 18 Day
Last modified on	2017 Year 07 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000013152