UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019611 |
|---|---|
| Receipt number | R000022611 |
| Scientific Title | Phase II trial of nab-paclitaxel and carboplatin with concurrent radiotherapy for patients with locally advanced non-small cell lung cancer |
| Date of disclosure of the study information | 2015/11/02 |
| Last modified on | 2020/05/27 15:58:50 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Phase II trial of nab-paclitaxel and carboplatin with concurrent radiotherapy for patients with locally advanced non-small cell lung cancer
Acronym
Phase II trial of nab-paclitaxel and carboplatin with concurrent radiotherapy for patients with locally advanced non-small cell lung cancer
Scientific Title
Phase II trial of nab-paclitaxel and carboplatin with concurrent radiotherapy for patients with locally advanced non-small cell lung cancer
Scientific Title:Acronym
Phase II trial of nab-paclitaxel and carboplatin with concurrent radiotherapy for patients with locally advanced non-small cell lung cancer
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 the efficacy of concurrent chemo-radiotherapy with nab-paclitaxel and carboplatin for patients with locally advanced non-small cell lung cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Responce Rate
Key secondary outcomes
Completion rate of the protocol treatment, Progression Free Survival, Overall Survival, Safety, Relative Dose Intensity
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
Concurrent chemoradiotherapy (radiotherapy 60Gy (2Gy/day) /6week, carboplatin AUC2, day1, 8, 15, 22, 29, 36 + nab-paclitaxel 40mg/m2, day1, 8, 15, 22, 29, 36) followed by consolidation chemotherapy (carboplatin AUC6, day1 + nab-paclitaxel 100mg/m2, day1,8,15 q4w, 2 courses)
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. Patient with histologically or cytologically confirmed NSCLC
2. Patient with measurable lesions
3. Clinical stage IIIA/B
4. V20 of the lung <=40%, based on CT-simulation
5. Patient without the treatment history of chemotherapy, radiotherapy and surgery for NSCLC
6. Performance Status (Eastern Cooperative Oncology Group: ECOG) 0-1
7. 20 years old or older, younger than 80
8. Patient without metastasis, diagnosed with contrast-enhanced CT of the chest and abdomen, bone scintigrapy, contrast-enhanced head CT or head MRI
9. Adequate organ function:
WBC >=3000/mm3
Neutrophil count >= 1,500 /mm3
Hemoglobin >= 9.0 g/dL
Platelet count >= 100,000 /mm3
Total bilirubin <= 1.5 mg/dL
AST <= twice of ULN
ALT <= twice of ULN
Serum creatinine <= 1.5 mg/dL
PaO2 >= 60mmHg
10. Written informed consent
Key exclusion criteria
1. Patient with a history of allergy to taxane antineoplastic agents
2. Patient with a history of allergy to carboplatin or other platinum-based antineoplastic agents
3. Patient with a history of allergy to albumin
4. without the concent to the risk of infection caused by albumin preparation
5. Patients with active infection
6. Patients with serious complications (e.g. heart failure, severe pulmonary emphysema, renal disfunction, hepatic disfunction, poorly controlled diabetes or hypertension)
7. Patient with severe bone marrow suppression
8. Patient with active double cancer within 5years prior to the study
9. Patients with pleural or pericardial effusion, or ascites.
10. Patient with motor paralysis or neuropathy, except due to NSCLC
11. Exhibiting significant interstitial pneumonitis, or pulmonary fibrosis in the chest radiograph
12. Patient with collagen vascular diseases
13. Female Patient in or having a chance or planning of pregnancy or breast feeding
14. Male patient in planning to impregnate
15. Inappropriate patients for this study judged by the attending physician
Target sample size
37
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keiko Shibuya |
Organization
Yamaguchi University Hospital
Division name
Department of Radiation Oncology
Zip code
Address
1-1-1, MinamiKogushi, Ube, Yamaguchi, Japan
TEL
0836-22-2966
kshibuya@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keiko Shibuya |
Organization
Yamaguchi University Hospital
Division name
Department of Radiation Oncology
Zip code
Address
1-1-1, MinamiKogushi, Ube, Yamaguchi, Japan
TEL
0836-22-2966
Homepage URL
kshibuya@yamaguchi-u.ac.jp
Sponsor or person
Institute
Department of Radiation Oncology, Yamaguchi University 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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 11 | Month | 02 | 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 | 08 | Month | 23 | Day |
Date of IRB
| 2017 | Year | 04 | Month | 26 | Day |
Anticipated trial start date
| 2013 | Year | 08 | Month | 30 | Day |
Last follow-up date
| 2017 | Year | 04 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 11 | Month | 02 | Day |
Last modified on
| 2020 | Year | 05 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022611
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
