UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031017
Receipt number R000035413
Scientific Title Weekly nab-Paclitaxel+Carboplatin with Radiotherapy as First Line Therapy in Patients with Advanced Non-Small-Cell Lung Cancer
Date of disclosure of the study information 2019/01/24
Last modified on 2018/01/26 15:36:33

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Weekly nab-Paclitaxel+Carboplatin with Radiotherapy as First Line Therapy in Patients with Advanced Non-Small-Cell Lung Cancer

Acronym

Weekly nab-Paclitaxel+Carboplatin with Radiotherapy as First Line Therapy in Patients with Advanced Non-Small-Cell Lung Cancer

Scientific Title

Weekly nab-Paclitaxel+Carboplatin with Radiotherapy as First Line Therapy in Patients with Advanced Non-Small-Cell Lung Cancer

Scientific Title:Acronym

Weekly nab-Paclitaxel+Carboplatin with Radiotherapy as First Line Therapy in Patients with Advanced Non-Small-Cell Lung Cancer

Region

Japan


Condition

Condition

Non-Small-Cell Lung Cancer

Classification by specialty

Chest surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

We confirmed the complete resection rate of Weekly nab-Paclitaxel / CBDCA + radiation therapy combination therapy as a preoperative introduction therapy for Stage IIIA and III B non-small cell lung cancer, and as secondary endopoint, 2 years no relapse survival rate, Evaluate progression free survival rate for 2 years.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The complete resection rate

Key secondary outcomes

2 years no relapse survival rate and progression free survival rate for 2 years.


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

Weekly nab-Paclitaxel+Carboplatin with Radiotherapy

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

79 years-old >=

Gender

Male and Female

Key inclusion criteria

1) Pathological stage IIIA, IIIB stage that is diagnosed as pathologically non-small cell lung cancer and judged to be resectable on the image.
2) Diagnosis of ipsilateral mediastinal lymph node metastasis (N2) is histologically proven (bronchoscopy, mediastinoscopy), or obvious swelling (minor diameter greater than 20 mm) allowed .
3) For T4, a case clearly showing invasion on the image (CT, MRI, PET - CT).
4) Cases with no resistance to chemotherapy or radiotherapy for non-small cell lung cancer
5) ECOG's Performance Status (PS) is 0 to 1.
6) The age is over 20 years old and under 79 years old.
7) Within 14 days prior to enrollment patients have adequate bone marrow, liver, kidney and lung function

Key exclusion criteria

1) Taxane and CBDCA are contraindicated for administration.
2) A history of severe drug sensitivity.
3) A history of hypersensitivity to albumin.
4)Interstitial pneumonia or pulmonary fibrosis apparent in chest radiography.
5) Active or duplicated cancer with metachronous or simultaneous, multiple cancers.
6) Pleural effusion, drainage and pericardial effusion required drainage.
7) Have serious complications.
8) Patients with peripheral neuropathy of Grade 2 or higher.
9) HBs antigen positive
10) Pregnant women or women who may be pregnant.
11) A man who is willing to conceive.
12) The doctor in charge judged unsuitable for registration of this exam.

Target sample size

25


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masato Sasaki

Organization

University of Fukui Faculty of
Medical Sciences

Division name

Division of Thoracic Surgery, Department of Surgery

Zip code


Address

23-3 Matsuoka- Shimoaizuki, Eiheiji, Fukui 910-1193, Japan

TEL

0776-61-3111

Email

masato@u-fukui.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Masato Sasaki

Organization

University of Fukui Faculty of Medical Sciences

Division name

Division of Thoracic Surgery, Department of Surgery

Zip code


Address

23-3 Matsuoka- Shimoaizuki, Eiheiji, Fukui 910-1193, Japan

TEL

0776-61-3111

Homepage URL


Email

masato@u-fukui.ac.jp


Sponsor or person

Institute

University of Fukui Faculty of Medical Sciences

Institute

Department

Personal name



Funding Source

Organization

University of Fukui Faculty of Medical Sciences

Organization

Division

Category of Funding Organization

Other

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

2019 Year 01 Month 24 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

Enrolling by invitation

Date of protocol fixation

2013 Year 12 Month 01 Day

Date of IRB


Anticipated trial start date

2013 Year 12 Month 01 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

2018 Year 01 Month 26 Day

Last modified on

2018 Year 01 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035413


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name