UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012719 |
|---|---|
| Receipt number | R000014671 |
| Scientific Title | A phase I/II study of chemoradiation with use of carboplatin/nab-paclitaxel and concurrent radiotherapy for local advanced non-small cell lung cancer |
| Date of disclosure of the study information | 2013/12/27 |
| Last modified on | 2019/01/04 23:05:00 |
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Basic information
Public title
A phase I/II study of chemoradiation with use of carboplatin/nab-paclitaxel and concurrent radiotherapy for local advanced non-small cell lung cancer
Acronym
A phase I/II study of chemoradiation with use of carboplatin/nab-paclitaxel and concurrent radiotherapy for local advanced non-small cell lung cancer
Scientific Title
A phase I/II study of chemoradiation with use of carboplatin/nab-paclitaxel and concurrent radiotherapy for local advanced non-small cell lung cancer
Scientific Title:Acronym
A phase I/II study of chemoradiation with use of carboplatin/nab-paclitaxel and concurrent radiotherapy for local 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 recommened doses and assess the efficacy and safety of Carboplatin plus nab-paclitaxel with concurrent Thoracic radiotherapy for 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 I:determine the recommended dose
phase II:2year survival rate
Key secondary outcomes
phase I:safety, response rate, progression free survival,overall survival, completion rate of chemoradiotherapy
phase II:safety, response rate, progression free survival, overall 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 weekly carboplatin plus nab-paclitaxel with concurrent thoracic radiotherapy for a total 60Gy at 2Gy/fraction/day 5times weekly for 30 times.
Consolidation therapy:
Combination of carboplatin plus nab-paclitaxel every 3 weeks for 2 cycles.
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 NSCLC.
2)Untreated Stage IIIA or IIIB disease
3)Unresectable
4)V20 under 35 percent and 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)Eastern Cooperative Oncology Group Performance Status(ECOG PS) 0 or 1
8)Organ functions are met for this study within two week before study entry.
9)With signed an informed consent document
Key exclusion criteria
1) With opposite hilar lymph nodes metastases
2) With interstitial lung disease, lung fibrosis
3) SVC syndrome
4) With active infection
5) With active double cancer
6) With other serious disease condition (bleeding, cardiac diseases, poorly controlled diabetes,etc.)
7) Clinically significant allergy
8) Patients with steroid treatment
9) Uncontrolled psychiatric disease
10) Pregnancy or lactating patients
11) Positive serum HBs antigen
12) Others
Target sample size
56
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Isamu Okamoto |
Organization
kyushu University Hospital
Division name
Center for Clinical and Translational Research
Zip code
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka City
TEL
0926425378
okamotoi@kokyu.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuko Kawano |
Organization
Kyushu Univiersity Hospital
Division name
Respiratory Medicine
Zip code
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka City
TEL
0926425378
Homepage URL
yukokawa@kokyu.med.kyushu-u.ac.jp
Sponsor or person
Institute
Research Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Taiho Pharmamedical Ltd
Organization
Division
Category of Funding Organization
Profit organization
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
| 2013 | Year | 12 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Main results already published
Date of protocol fixation
| 2013 | Year | 12 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 12 | Month | 27 | 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 | 12 | Month | 27 | Day |
Last modified on
| 2019 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014671
