UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012531 |
|---|---|
| Receipt number | R000014660 |
| Scientific Title | A phase I/II trial of concurrent thoracic radiotherapy with the combination of cisplatin and nab-pacliaxel for locally advanced non-small cell lung cancer |
| Date of disclosure of the study information | 2013/12/09 |
| Last modified on | 2019/06/14 11:16:53 |
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Basic information
Public title
A phase I/II trial of concurrent thoracic radiotherapy with the combination of cisplatin and nab-pacliaxel for locally advanced non-small cell lung cancer
Acronym
A phase I/II trial of concurrent thoracic radiotherapy with the combination of cisplatin and nab-pacliaxel for locally advanced non-small cell lung cancer
Scientific Title
A phase I/II trial of concurrent thoracic radiotherapy with the combination of cisplatin and nab-pacliaxel for locally advanced non-small cell lung cancer
Scientific Title:Acronym
A phase I/II trial of concurrent thoracic radiotherapy with the combination of cisplatin and nab-pacliaxel for locally advanced non-small cell lung cancer
Region
| Japan |
Condition
Condition
locally advanced non-small cell lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine the recommended dose and assess the efficacy and safety of chemoradiotherapy with cisplatin plus nab-paclitaxel in patients with locally advanced non-small cell lung cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
phase 1:determine the recommended dose
phase 2:2year survival rate
Key secondary outcomes
phase 1:safety, response rate, 2year survival rate, progression free survival, completion rate of chemoradiotherapy
phase 2:safety, response rate, progression free survival, completion rate of chemoradiotherapy
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
Chemoradiotherapy:
Combination of cisplatin plus nab-paclitaxel with concurrent thoracic radiotherapy 2Gy/day for 30 times
Consolidation therapy:
Combination of cisplatin 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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Cytologically or histologically documented non-small cell carcinoma of the lung. 2) Previously untreated Stage IIIA or IIIB
3) Unresectable
4) An approval of a radiotherapist by CT simulation based on the restriction of this protcol before registration.
5) Have measurable lesion
6) Patient aged 20-74 years old at the time of consent.
7) Have Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0~1
8) Have adequate organ function within two week before study entry
9) Have signed an informed consent document
Key exclusion criteria
1) Pulmonary disorder (idiopathic pulmonary fibrosis, interstitial lung disease, pneumoconiosis, active radiation pneumonia, etc.).
2) SVC syndrome
3) With active infection
4) With active double cancer.
5) With other serious disease condition (bleeding, cardiac diseases, poorly controlled diabetes, etc.)
6) Clinically significant drug allergy
7) Patients with steroid treatment.
8) Uncontrolled psychiatric disease.
9) Pregnancy or lactating patients
10) Positive serum HBs antigen or HCV antibody
11) Others
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiko |
| Middle name | |
| Last name | Nakagawa |
Organization
Kindai University Faculty of Medicine
Division name
Department of Medical Oncology
Zip code
5898511
Address
377-2 Ohno-higashi, Osaka-Sayama, Osaka
TEL
072-366-0221
nakagawa@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | Hidetoshi |
| Middle name | |
| Last name | Hayashi |
Organization
Kindai University Faculty of Medicine
Division name
Department of Medical Oncology
Zip code
5898511
Address
377-2 Ohno-higashi, Osaka-Sayama, Osaka
TEL
0723-66-0221
Homepage URL
hidet31@gmail.com
Sponsor or person
Institute
Department of Medical Oncology, Kindai University, Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
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
Research Ethics Committee of the Faculty of Medicine of the University of Kindai
Address
377-2 Ohno-higashi, Osaka-Sayama, Osaka
Tel
0723-66-0221
zizen@med.kindai.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
近畿大学医学部附属病院 腫瘍内科、市立岸和田市民病院 腫瘍内科、関西医科大学附属枚方病院 呼吸器腫瘍内科、倉敷中央病院 呼吸器内科、大阪医科大学付属病院 呼吸器内科
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 12 | Month | 09 | 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
Completed
Date of protocol fixation
| 2013 | Year | 12 | Month | 09 | Day |
Date of IRB
| 2013 | Year | 12 | Month | 05 | Day |
Anticipated trial start date
| 2014 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 12 | Month | 09 | Day |
Last modified on
| 2019 | Year | 06 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014660
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