UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011681 |
|---|---|
| Receipt number | R000013595 |
| Scientific Title | Phase II study of nab-paclitaxel and carboplatin with concurrent thoracic radiotherapy in patients with unresectable locally advanced non-small cell lung cancer |
| Date of disclosure of the study information | 2013/09/09 |
| Last modified on | 2015/03/10 11:56:20 |
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Basic information
Public title
Phase II study of nab-paclitaxel and carboplatin with concurrent thoracic radiotherapy in patients with unresectable locally advanced non-small cell lung cancer
Acronym
Phase II study of ABI + CBDCA + TRT for unresectable LA-NSCLC
Scientific Title
Phase II study of nab-paclitaxel and carboplatin with concurrent thoracic radiotherapy in patients with unresectable locally advanced non-small cell lung cancer
Scientific Title:Acronym
Phase II study of ABI + CBDCA + TRT for unresectable LA-NSCLC
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy and safety of nab-paclitaxel and carboplatin with concurrent thoracic radiotherapy for unresectable locally advanced non-small cell lung cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Response rate
Key secondary outcomes
Incidence and Severity of Adverse Events
Treatment completion rate of Chemoradiotherapy
Progression free survival
Overall survival
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
nab-paclitaxel:Nab-paclitaxel is administered intravenously at a dose of 40mg/m2 on days 1,8,15,22,29,36.
carboplatin:Carboplatin is administered intravenously at a dose of AUC2 on days 1,8,15,22,29,36.
Radiation:2Gy, 5fr/week 6 weeks, Total 60Gy.
Consolidation
2cycles of chemotherapy with nab-paclitaxel and carboplatin will be performed after chemoradiotherapy.
nab-paclitaxel:Nab-paclitaxel is administered intravenously at a dose of 100mg/m2 on days 1,8,15.
carboplatin:Carboplatin is administered intravenously at a dose of AUC5 on day 1.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Histologically or cytologically confirmed non-small cell lung cancer.
2)Unresectable clinical stage IIIA or IIIB.
3)Over 20 years at registration.
4)ECOG Performance Status(PS) of 0 or 1.
5)At least one measurable lesion.
6)Patients with no previous treatment(radiotherapy, chemotherapy etc) for non-small cell lung cancer.
7)Sufficient function of major organs as defined below.
White blood cell count>=4,000 /mm3
Neutrophil count>=2,000 /mm3
Platelet count>=100,000 /mm3
Hemoglobin>=9.5 g/dL
Total bilirubin<=1.5 mg/dL
AST and ALT<=100 U/L
Serum creatinine<=1.2 mg/dL
PaO2>=70 torr
8)Voluntarily signed the written consent form.
Key exclusion criteria
1)Active double cancer.
2)Active infections requiring systemic treatment.
3)Serious complications(e.g. heart failure, renal failure, hepatic failure, haemorrhagic peptic ulcer, intestinal paralysis, intestinal obstruction or poorly controlled diabetes)
4)Grade2 or higher peripheral neuropathy.
5)Positive HBs antigen and/or HCV antibody.
6)History of severe drug allergy.
7)History of hypersensivity for albumin-containing agents.
8)Pregnant females, possibly pregnant females, females wishing to become pregnant and nursing mothers.Males that are currently attempting to produce a pregnancy.
9)Judged ineligible by physicians for participation in the study from a safety viewpoint.
Target sample size
32
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiyuki Sawa |
Organization
Gifu Municipal Hospital
Division name
Department of respiratory and medical oncology
Zip code
Address
7-1 Kashima-cho Gifu city
TEL
058-251-1101
sawatoshiyuki@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takaaki Hasegawa |
Organization
Gifu Municipal Hospital
Division name
Department of respiratory and medical oncology
Zip code
Address
7-1 Kashima-cho Gifu city
TEL
058-251-1101
Homepage URL
takaaki_hase@bird.ocn.ne.jp
Sponsor or person
Institute
Gifu Municipal Hospital
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
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
岐阜市民病院（岐阜県）
岐阜大学医学部付属病院（岐阜県）
長良医療センター（岐阜県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 09 | 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
Terminated
Date of protocol fixation
| 2013 | Year | 07 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 09 | Month | 09 | Day |
Last follow-up date
| 2017 | Year | 08 | 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 | 09 | Month | 08 | Day |
Last modified on
| 2015 | Year | 03 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013595
