UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012505
Receipt number R000014598
Scientific Title Feasibility study of adjuvant chemotherapy with nab-paclitaxel and carboplatin in patients with completely resected pathological IB squamous cell lung cancer, II and IIIA non-small cell lung cancer
Date of disclosure of the study information 2013/12/06
Last modified on 2020/06/11 15:19:33

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Basic information

Public title

Feasibility study of adjuvant chemotherapy with nab-paclitaxel and carboplatin in patients with completely resected pathological IB squamous cell lung cancer, II and IIIA non-small cell lung cancer

Acronym

Feasibility study of adjuvant nab-PTX/CBDCA for StageIB SqLC, II and IIIA NSCLC

Scientific Title

Feasibility study of adjuvant chemotherapy with nab-paclitaxel and carboplatin in patients with completely resected pathological IB squamous cell lung cancer, II and IIIA non-small cell lung cancer

Scientific Title:Acronym

Feasibility study of adjuvant nab-PTX/CBDCA for StageIB SqLC, II and IIIA NSCLC

Region

Japan


Condition

Condition

Non-small cell lung cancer

Classification by specialty

Chest surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to evaluate the feasibility of Nab-PTX plus CBDCA as adjuvant chemotherapy in patients with completely resected pathological IB squamous cell lung cancer, II and IIIA non-small cell lung cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The completion rate

Key secondary outcomes

toxicities, disease-free survival, overall survival, recurrence type


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

Nab-paclitaxel at the dose of 100mg/m2 (day 1, 8, 15) and carboplatin at the dose of area under curve 5 (day 1) are administered every 4 weeks and repeated 4 course.

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 proven non-small cell lung cancer, except for low-malignant potential tumor such as mucoepidermoid carcinoma or adenoid cystic carcinoma, and large cell neuroendocrine carcinoma.
2) Pathological stage IB squamous cell lung cancer or stage II, IIIA non-small cell lung cancer
3) With complete resection
4) At least lobectomy (tracheobronchoplasty is permitted)
5) LN dissection (ND2a) or Elective Lymph Node Dissection
6) No prior anti-cancer treatment for thoracic malignancy except for this operation
7) ECOG PS 0-1
8) More than 20 years of age, under 75 years of age
9) Adequate organ function
*Neutrophil count => 1,500/&micro;L
*Platelet => 100,000/&micro;L
*Hemoglobin => 9.0g/dL
*AST/ALT < 2.5 times less than ULN
*T.Bill <= 1.5mg/dL
*Serum creatinine = 1.5mg/dL
*ECG: without clinically problematic abnormalities
10) Within 10 weeks after surgery
11) With written informed consent

Key exclusion criteria

1) Not recovered from surgical complications
2) Active infection such as bacterial infection
3) Patients with interstitial pneumonitis or pulmonary fibrosis, as determined by chest CT
4) patients with myocardial infraction within 6 months
5) Patients with uncontrolled complications
6) With the history of hypersensitivity for nab-paclitaxel or CBDCA
7) Grade 2 or greater peripheral neuropathy
8) Active concomitant malignancy
9) Pregnant females, nursing mothers, possibly pregnant females, females wishing to become pregnant and Males that are currently attempting to produce a pregnancy
10) Other conditions not suitable for this study

Target sample size

45


Research contact person

Name of lead principal investigator

1st name Masayuki
Middle name
Last name Chida

Organization

Dokkyo Medical University

Division name

General Thoracic Surgery

Zip code

321-0293

Address

880 Kitakobayashi, Mibu-machi, Shimotsuga-gun, Tochigi

TEL

0282-86-1111

Email

chidaths@dokkyomed.ac.jp


Public contact

Name of contact person

1st name Masayuki
Middle name
Last name Chida

Organization

Dokkyo Medical University

Division name

Thoracic Surgery

Zip code

321-0293

Address

880 Kitakobayashi, Mibu-machi, Shimotsuga-gun, Tochigi

TEL

0282-86-1111

Homepage URL


Email

chidaths@dokkyomed.ac.jp


Sponsor or person

Institute

Dokkyo Medical University department of General thoracic surgery

Institute

Department

Personal name



Funding Source

Organization

Dokkyo Medical University department of General thoracic surgery

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

Dokkyo Medical University

Address

880 Kitakobayashi, Mibu-machi, Shimotsuga-gun, Tochigi

Tel

0282-86-1111

Email

kobayasi@dokkyomed.ac.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

獨協医科大学病院、自治医科大学付属病院


Other administrative information

Date of disclosure of the study information

2013 Year 12 Month 06 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 08 Month 01 Day

Date of IRB


Anticipated trial start date

2013 Year 08 Month 01 Day

Last follow-up date

2018 Year 07 Month 31 Day

Date of closure to data entry

2018 Year 07 Month 31 Day

Date trial data considered complete

2018 Year 07 Month 31 Day

Date analysis concluded

2018 Year 07 Month 31 Day


Other

Other related information



Management information

Registered date

2013 Year 12 Month 06 Day

Last modified on

2020 Year 06 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014598


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name