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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000029435
Receipt No. R000033629
Scientific Title A phase II study of multimodality therapy with introduction chemoradiotherapy before surgery in patients with pathological mediastinal lymph node metastasis (N2 Stage IIIA) non -small cell lung cancer
Date of disclosure of the study information 2017/10/10
Last modified on 2019/03/29

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Basic information
Public title A phase II study of multimodality therapy with introduction chemoradiotherapy before surgery in patients with pathological mediastinal lymph node metastasis (N2 Stage IIIA) non -small cell lung cancer
Acronym A phase II study of multimodality therapy with introduction chemoradiotherapy before surgery in patients with pathological mediastinal lymph node metastasis (N2 Stage IIIA) non -small cell lung cancer
Scientific Title A phase II study of multimodality therapy with introduction chemoradiotherapy before surgery in patients with pathological mediastinal lymph node metastasis (N2 Stage IIIA) non -small cell lung cancer
Scientific Title:Acronym A phase II study of multimodality therapy with introduction chemoradiotherapy before surgery in patients with pathological mediastinal lymph node metastasis (N2 Stage IIIA) non -small cell lung cancer
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 efficacy of introduction chemoradiotherapy before surgery in patients with pathological mediastinal lymph node metastasis non-small cell lung cancer.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes 2 year recurrence-free survival rate
Key secondary outcomes Recurrence-free survival time
Overall survival time
Accomplish treatment rate
Response rate of introduction chemoradiotherapy
Safety

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Combination treatment with carboplatin (AUC = 5),Day1,29 + Nab-PTX(80mg/m2), Day1, 8, 15, 29, 36, 42.
Radiation therapy ; started once a day 1.8 Gy from Day 1, 25 times in total, 45 Gy.
Resection more than lobectomy with mediastinal lymph node dissection of ND2a or more.
Combination treatment with carboplatin (AUC = 5),Day1,29 + Nab-PTX(80mg/m2), Day1, 8, 15, 29, 36, 42.
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

Not applicable
Gender Male and Female
Key inclusion criteria 1. Pathologically confirmed stage IIIA, N2, non-small cell lung cancer
2. 20 or older at registration
3. ECOG PS of 0-1
4. Without receiving cytotoxic agents chemotherapy or chest radiotherapy
5.Complete resection can be expected by lobectomy after introduction chemoradiotherapy
6.Postoperative prediction FEV 1.0 <800 ml
7. Adequate organ function
Neutrophil cout of more than 1,500/mm3
Hemoglobin cout of more than 9.0g/dL
Platelet cout of more than 100,000/mm3
Aspartate transaminase (AST), alanine tran
Serum albumin: more than 3.0g/dL
saminase(ALT): less than 100IU/L
Total bilirubin: less than 2.0mg/dL
Serum creatinine of less than 1.5mg/dL
SpO2 of more than 94%
Key exclusion criteria 1. History of severe hypersensitivity to taxane group
2. History of severe hypersensitivity to Carboplatin
3. History of severe hypersensitivity to albumin preparation
4. Interstitial lung disease or pulmonary fibrosis
5. Severe infectious disease or severe uncontrolled complication
6. Active malignancy of other organ
7. HBs antigen positive
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshihide Yokoyama
Organization Kurashiki Central Hospital
Division name Department of respiratory medicine
Zip code
Address 1-1-1 Miwa, Kurashiki, Okayama pref. Japan
TEL 086-422-0210
Email y14401@kchnet.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toshihide Yokoyama
Organization Kurashiki Central Hospital
Division name Department of respiratory medicine
Zip code
Address 1-1-1 Miwa, Kurashiki, Okayama pref. Japan
TEL 086-422-0210
Homepage URL
Email y14401@kchnet.or.jp

Sponsor
Institute Department of respiratory medicine,
Kurashiki Central Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
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 公益財団法人大原記念倉敷中央医療機構 倉敷中央病院

Other administrative information
Date of disclosure of the study information
2017 Year 10 Month 10 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 Enrolling by invitation
Date of protocol fixation
2017 Year 09 Month 25 Day
Date of IRB
Anticipated trial start date
2017 Year 10 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 10 Month 05 Day
Last modified on
2019 Year 03 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033629

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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