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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011225
Receipt No. R000013152
Scientific Title Feasibility study of postoperative adjuvant carboplatin plus nab-paclitaxel for complete resected pathological stage II/IIIA non-small cell lung cancer
Date of disclosure of the study information 2013/07/19
Last modified on 2017/07/21

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Basic information
Public title Feasibility study of postoperative adjuvant carboplatin plus nab-paclitaxel for complete resected pathological stage II/IIIA non-small cell lung cancer
Acronym FASTnab
Scientific Title Feasibility study of postoperative adjuvant carboplatin plus nab-paclitaxel for complete resected pathological stage II/IIIA non-small cell lung cancer
Scientific Title:Acronym 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
1st name
Middle name
Last name Hisashi Saji
Organization St. Marianna University School of Medicine
Division name Chest Surgery
Zip code
Address 2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa, 216-8511, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization St. Marianna University School of Medicine
Division name Chest Surgery
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.ncbi.nlm.nih.gov/pubmed/28538017
Number of participants that the trial has enrolled
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 
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 Completed
Date of protocol fixation
2013 Year 06 Month 04 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000013152

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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