UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011534 |
|---|---|
| Receipt number | R000013471 |
| Scientific Title | Phase II study of nab-paclitaxel and carboplatin for elderly patients with non-small cell lung cancer. (KRSG1303) |
| Date of disclosure of the study information | 2013/09/01 |
| Last modified on | 2019/02/23 10:03:26 |
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Basic information
Public title
Phase II study of nab-paclitaxel and carboplatin for elderly patients with non-small cell lung cancer. (KRSG1303)
Acronym
Phase II study of nab-paclitaxel and carboplatin for elderly patients with non-small cell lung cancer. (KRSG1303)
Scientific Title
Phase II study of nab-paclitaxel and carboplatin for elderly patients with non-small cell lung cancer. (KRSG1303)
Scientific Title:Acronym
Phase II study of nab-paclitaxel and carboplatin for elderly patients with non-small cell lung cancer. (KRSG1303)
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We evaluate efficacy and safety of nab-paclitaxel and carboplatin for elderly (more than 75 years-old) patients with untreated non-small cell lung cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Response rate
Key secondary outcomes
Disease control rate, Frequent of adverse event, Progression free survival, Overall Survival, Rate of secondary treatment
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
Nab-paclitaxel is administered 100 mg/m2 on day 1, 8, 15 every 3 weeks, Carboplatin is administered AUC5 on day 1 every 3weeks.
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
| 75 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Histologically or cytologically confirmed Clinical Stage IIIB, IV or postoperative recurrence
2) Age of more than 75 years-old
3) Not with active other organ cancer
4) With one or more measurable lesion
5) No prior chemotherapy
Adjuvant chemotherapy finished before 4 weeks or more in case of UFT, 12 months or more in case of other chemotherapy from enrollment is permitted.
6) With adequate organ function of bone marrow reserve, liver, and kidney.
Sufficient major organ function as bellow
Neutrophil count => 1,500 /mm3
Platelet count => 100,000 /mm3
Hemoglobin => 9.0 g/dL
AST(GOT)/ALT(GPT) <= 2.5 times less than ULN
total bilirubin <= 1.5 mg/dL
Serum creatinine <= 1.5 mg/dL
ECG: without clinically problematic abnorbomalities
Peripheral neuropathy <= Grade 1
7) Life expectancy of at least 3 months
8) ECOG Performance status of 0-1
9) Written informed consent
Key exclusion criteria
1) Patients with Symptomatic brain metastasis
2) Patients have only non-measurable lesion
3) Patients with radiotherapy for cancer within 4 weeks
4) Patients with interstitial pneumonia
5) Patients with Serious complications (renal dysfunction, liver dysfunction, cardiac diseases, uncontrolled hypertension or diabetes)
6) Patients with other Serious complications
7) Judged ineligible based on physicians' decision
Target sample size
32
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinichiro Koyama |
Organization
Jichi Medical University Saitama Medical Center
Division name
Division of Pulmonary Medicine, Clinical Department of Internal Medicine
Zip code
Address
1-847 Amanuma-cho, Omiya-ku, Saitama-shi, 330-8503, Saitama, Japan
TEL
048-647-2111
skoyama@omiya.jichi.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nobuyuki Koyama |
Organization
Tokyo Medical University Hachioji Medical Center
Division name
Department of Clinical Oncology
Zip code
Address
1163 Tatenachi, Hachioji-shi, Tokyo, 193-0998, Japan
TEL
042-665-5611
Homepage URL
nkoyama@tokyo-med.ac.jp
Sponsor or person
Institute
Kanto respiratory disease study group
Institute
Department
Personal name
Funding Source
Organization
Kanto respiratory disease study group
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
埼玉県立循環器呼吸器病センター
防衛医科大学校
さいたま市立病院
埼玉医科大学呼吸器病センター
埼玉医科大学国際医療センター
足利赤十字病院
さいたま赤十字病院
独法東埼玉病院
独法西群馬病院
深谷赤十字病院
栃木県立がんセンター
埼玉医科大学総合医療センター
自治医科大学付属病院
済生会宇都宮病院
前橋赤十字病院
自治医科大学附属さいたま医療センター
獨協医科大学越谷病院
東京医科大学八王子医療センター
東京医科大学茨城医療センター
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 09 | 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
This trial stopped because the targeted number of cases cannot be achieved.
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 | 06 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 08 | Month | 20 | Day |
Last modified on
| 2019 | Year | 02 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013471
