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 |
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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
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
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
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
