UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012505 |
|---|---|
| Receipt number | R000014598 |
| Scientific Title | Feasibility study of adjuvant chemotherapy with nab-paclitaxel and carboplatin in patients with completely resected pathological IB squamous cell lung cancer, II and IIIA non-small cell lung cancer |
| Date of disclosure of the study information | 2013/12/06 |
| Last modified on | 2020/06/11 15:19:33 |
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Basic information
Public title
Feasibility study of adjuvant chemotherapy with nab-paclitaxel and carboplatin in patients with completely resected pathological IB squamous cell lung cancer, II and IIIA non-small cell lung cancer
Acronym
Feasibility study of adjuvant nab-PTX/CBDCA for StageIB SqLC, II and IIIA NSCLC
Scientific Title
Feasibility study of adjuvant chemotherapy with nab-paclitaxel and carboplatin in patients with completely resected pathological IB squamous cell lung cancer, II and IIIA non-small cell lung cancer
Scientific Title:Acronym
Feasibility study of adjuvant nab-PTX/CBDCA for StageIB SqLC, II and IIIA NSCLC
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the feasibility of Nab-PTX plus CBDCA as adjuvant chemotherapy in patients with completely resected pathological IB squamous cell lung cancer, II and IIIA non-small cell lung cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The completion rate
Key secondary outcomes
toxicities, disease-free survival, overall survival, recurrence type
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 at the dose of 100mg/m2 (day 1, 8, 15) and carboplatin at the dose of area under curve 5 (day 1) are administered every 4 weeks and repeated 4 course.
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Pathologically proven non-small cell lung cancer, except for low-malignant potential tumor such as mucoepidermoid carcinoma or adenoid cystic carcinoma, and large cell neuroendocrine carcinoma.
2) Pathological stage IB squamous cell lung cancer or stage II, IIIA non-small cell lung cancer
3) With complete resection
4) At least lobectomy (tracheobronchoplasty is permitted)
5) LN dissection (ND2a) or Elective Lymph Node Dissection
6) No prior anti-cancer treatment for thoracic malignancy except for this operation
7) ECOG PS 0-1
8) More than 20 years of age, under 75 years of age
9) Adequate organ function
*Neutrophil count => 1,500/µL
*Platelet => 100,000/µL
*Hemoglobin => 9.0g/dL
*AST/ALT < 2.5 times less than ULN
*T.Bill <= 1.5mg/dL
*Serum creatinine = 1.5mg/dL
*ECG: without clinically problematic abnormalities
10) Within 10 weeks after surgery
11) With written informed consent
Key exclusion criteria
1) Not recovered from surgical complications
2) Active infection such as bacterial infection
3) Patients with interstitial pneumonitis or pulmonary fibrosis, as determined by chest CT
4) patients with myocardial infraction within 6 months
5) Patients with uncontrolled complications
6) With the history of hypersensitivity for nab-paclitaxel or CBDCA
7) Grade 2 or greater peripheral neuropathy
8) Active concomitant malignancy
9) Pregnant females, nursing mothers, possibly pregnant females, females wishing to become pregnant and Males that are currently attempting to produce a pregnancy
10) Other conditions not suitable for this study
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Masayuki |
| Middle name | |
| Last name | Chida |
Organization
Dokkyo Medical University
Division name
General Thoracic Surgery
Zip code
321-0293
Address
880 Kitakobayashi, Mibu-machi, Shimotsuga-gun, Tochigi
TEL
0282-86-1111
chidaths@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | Masayuki |
| Middle name | |
| Last name | Chida |
Organization
Dokkyo Medical University
Division name
Thoracic Surgery
Zip code
321-0293
Address
880 Kitakobayashi, Mibu-machi, Shimotsuga-gun, Tochigi
TEL
0282-86-1111
Homepage URL
chidaths@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University department of General thoracic surgery
Institute
Department
Personal name
Funding Source
Organization
Dokkyo Medical University department of General thoracic surgery
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
Dokkyo Medical University
Address
880 Kitakobayashi, Mibu-machi, Shimotsuga-gun, Tochigi
Tel
0282-86-1111
kobayasi@dokkyomed.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
獨協医科大学病院、自治医科大学付属病院
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 12 | Month | 06 | 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 | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 07 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 12 | Month | 06 | Day |
Last modified on
| 2020 | Year | 06 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014598
