UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010480 |
|---|---|
| Receipt number | R000012231 |
| Scientific Title | Phase I trial of biweekly Carboplatin plus nab-Paclitaxel with concurrent thoracic radiotherapy in patients with locally advanced non-small cell lung cancer |
| Date of disclosure of the study information | 2013/05/01 |
| Last modified on | 2021/04/18 09:15:04 |
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Basic information
Public title
Phase I trial of biweekly Carboplatin plus nab-Paclitaxel with concurrent thoracic radiotherapy in patients with locally advanced non-small cell lung cancer
Acronym
Phase I trial of biweekly CBDCA + nab-PTX +TRT for LA-NSCLC
Scientific Title
Phase I trial of biweekly Carboplatin plus nab-Paclitaxel with concurrent thoracic radiotherapy in patients with locally advanced non-small cell lung cancer
Scientific Title:Acronym
Phase I trial of biweekly CBDCA + nab-PTX +TRT for LA-NSCLC
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the dose limiting toxicity (DLT), estimate maximum tolerated dose (MTD) and determine recommend dose (RD) of biweekly Carboplatin plus nab-Paclitaxel with concurrent thoracic radiotherapy in patients with locally advanced non-small cell lung cancer. And also we evaluate the efficacy of biweekly Carboplatin plus nab-Paclitaxel with concurrent thoracic radiotherapy.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
Incidence of dose limiting toxicities at each dose level
Key secondary outcomes
Incidence and Severity of Adverse Events
Treatment completion rate
Response Rate
2-year survival rate
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
Radiotherapy: 2Gy, 5fr/week 6weeks, Total 60Gy
Carboplatin: AUC 4, day 1, 15, 29
nab-Paclitaxel: dose of each level, day 1, 15, 29
Level 1: 60 mg/m2
Level 2: 80 mg/m2
Level 3: 100 mg/m2
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) Histologically or cytologically confirmed non-small cell lung cancer.
2) Clinical Stage IIIA or IIIB.
3) No prior therapy for NSCLC.
4) V20 is 35% or less by CT simulation before enrollment.
5) At least one measurable lesion.
6) ECOG Performance status of 0-1.
7) Age of 20 to 74 years.
8) Sufficient major organ function as bellow.
*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 <= 100 IU/L
*ALT <= 100 IU/L
*Serum creatinine <= 1.5 mg/dL
*PaO2 >= 70 Torr or more
9) Written informed consent.
Key exclusion criteria
1) Patients with T3N1.
2) Superior vena cava syndrome.
3) Contralateral hilar lymph node metastasis, malignant plueral, pericardial effusion, carcinomatous lymphangiosis.
4) Active double cancer.
5) Active infections requiring systemic treatment.
6) Severe concurrent disease (Pulmonary fibrosis or interstitial pneumonia, renal failure, hepatic failure, cerebrovascular disease, ischemic heart disease requiring treatment, arrhythmia, cardiac infarction within 6 months before enrollment, hemorrhagic peptic ulcer, poorly controlled diabetes).
7) Grade 2 or higher peripheral neuropathy.
8) Positive HBs antigen and/or HCV antibody.
9) History of Severe drug allergies.
10) Pregnant females, possibly pregnant females, females wishing to become pregnant and nursing mothers. Males that are currently attempting to produce a pregnancy.
11) Physician concludes that the patient's participation in this trial is inappropriate.
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | Yukihiro |
| Middle name | |
| Last name | Hasegawa |
Organization
Aomori Prefectural Central Hospital
Division name
Department of Respiratory Medicine
Zip code
030-0913
Address
2-1-1 Higashi Tsukurimichi, Aomori 030-8553, Japan
TEL
017-726-8111
yukihiro_hasegawa@med.pref.aomori.jp
Public contact
Name of contact person
| 1st name | Yukihiro |
| Middle name | |
| Last name | Hasegawa |
Organization
Aomori Prefectural Central Hospital
Division name
Department of Respiratory Medicine
Zip code
030-0913
Address
2-1-1 Higashi Tsukurimichi, Aomori 030-8553
TEL
017-726-8111
Homepage URL
yukihiro_hasegawa@med.pref.aomori.jp
Sponsor or person
Institute
Aomori Prefectural Central 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
Aomori Prefectural Central Hospital
Address
2-1-1 Higashi Tsukurimichi, Aomori 030-8553
Tel
017-726-8111
kenbyo@pref.aomori.lg.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
青森県立中央病院（青森県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 05 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2013 | Year | 04 | Month | 12 | Day |
Date of IRB
| 2013 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2013 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 02 | Month | 12 | 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 | 04 | Month | 12 | Day |
Last modified on
| 2021 | Year | 04 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012231
