UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011225
Receipt number 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 09:26:03

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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 or person

Institute

St. Marianna University School of Medicine

Institute

Department

Personal name



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

Value
https://center6.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