UMIN-CTR Clinical Trial

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
Email	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
Email	kshibuya@yamaguchi-u.ac.jp

Sponsor
Institute	Department of Radiation Oncology, Yamaguchi University Hospital
Institute
Department

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
Email

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022611