UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025010 |
|---|---|
| Receipt number | R000028775 |
| Scientific Title | Induction Chemotherapy and Adjuvant Thoracic Radiation in Resectable Stage N2-3A/3B Non-small Cell Lung Cancer (ICAT study) |
| Date of disclosure of the study information | 2016/12/01 |
| Last modified on | 2021/09/02 14:39:14 |
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Basic information
Public title
Induction Chemotherapy and Adjuvant Thoracic Radiation in Resectable Stage N2-3A/3B Non-small Cell Lung Cancer (ICAT study)
Acronym
Trimodality with Adjuvant Radiation in Stage N2-3A/3B Non-small Cell Lung Cancer
Scientific Title
Induction Chemotherapy and Adjuvant Thoracic Radiation in Resectable Stage N2-3A/3B Non-small Cell Lung Cancer (ICAT study)
Scientific Title:Acronym
Trimodality with Adjuvant Radiation in Stage N2-3A/3B Non-small Cell Lung Cancer
Region
| Japan |
Condition
Condition
Resectable Stage 3A-N2 Non-small Cell Lung Cancer
Classification by specialty
| Pneumology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the feasibility of trimodality treatment with induction chemotherapy, radical surgery, and adjuvant radiation in stage 3A-N2 non-small cell lung cancer
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
feasibility
Key secondary outcomes
response rate of induction chemotherapy, safety, progression free survival
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 | Maneuver |
Interventions/Control_1
Trimodality treatment with 3 course of induction chemotherapy with Carboplatin AUC5 and nab-Paclitaxel 100mg/m2, radical surgery more than lobectomy, adjuvant radiation 50Gy
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Stage 3A non-small-cell lung cancer (NSCLC) with mediastinal lymph node metastasis (N2) confirmed pathologically without chest wall invasion
2.R0 radical surgery is expected after induction chemotherapy
3.Normal pulmonary function (%VC > 80%, FEV1% > 70%) within 56 days prior to consent
4.Chemotherapy-naive and radiotherapy-naive
5.20 - 75 years of age at enrollment
6.ECOG Performance Status 0-1
7.The latest clinical laboratory test within 28 days prior to enrollment meets the following all standard
Leukocyte count > 3,000/mm3
Hemoglobin > 10.0g/dl
Platelet > 100,000/mm3
Total bilirubin < 1.5mg/dl
Serum albumin > 3.0g/dl
AST/ALT < 100 IU
Creatinine < 1.2mg/dl
SpO2 > 95%
8.Patients providing the written informed consent for this trial
Key exclusion criteria
1.Evident unresectable extranodal lymph node involvement in CT scanning
2.Contraindication to either carboplatin or nab-paclitaxel
3.History of severe drug hypersensitivity
4.Impaired pulmonary function
5.Myocardial infarction within 6 months (180 days) prior to consent
6.Interstitial pneumonia, pulmonary fibrosis suspected or diagnosed within 56 days prior to consent
7.Administration of prednisolone > 10mg/day within 90 days prior to consent
8.Clinically severe heart diseases
9.Clinically severe psychiatric diseases
10.Uncontrollable diabetes mellitus
11.Clinically active infection
12.Any other severe complication
13.Active double malignancies
14.Pregnant, lactating or possibly pregnant
15.Any other unsuitable reasons judged by attending investigators
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Masayoshi |
| Middle name | |
| Last name | Inoue |
Organization
Kyoto Prefectural University of Medicine
Division name
Division of Thoracic Surgery, Department of Surgery
Zip code
6028566
Address
Kajii-cho 465, Kawaramachi-Hirokoji, Kamigyo-Ku ,Kyoto
TEL
+81752515739
mainoue@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Hiroaki |
| Middle name | |
| Last name | Tsunezuka |
Organization
Kyoto Prefectural University of Medicine
Division name
Division of Thoracic Surgery, Department of Surgery
Zip code
6028566
Address
Kajii-cho 465, Kawaramachi-Hirokoji, Kamigyo-Ku ,Kyoto
TEL
075-251-5739
Homepage URL
tsune@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kyoto Prefectural University of Medicine
Division of Thoracic Surgery, Department of Surgery
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kyoto Prefectural University of Medicine
The Center for Quality Assurance in Research and Development
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto Prefectural University of Medicine, IRB
Address
Kajii-cho 465, Kawaramachi-Hirokoji, Kamigyo-Ku ,Kyoto
Tel
0752515337
rinri@koto.kpu-m.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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
1
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
Completed
Date of protocol fixation
| 2016 | Year | 12 | Month | 15 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 13 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 06 | Month | 16 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 11 | Month | 27 | Day |
Last modified on
| 2021 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028775
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