UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029435 |
|---|---|
| Receipt number | 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 | 2020/10/12 14:52:17 |
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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
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
y14401@kchnet.or.jp
Sponsor or person
Institute
Department of respiratory medicine,
Kurashiki Central Hospital
Institute
Department
Personal name
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
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
Terminated
Date of protocol fixation
| 2017 | Year | 09 | Month | 25 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 21 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 10 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
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
| 2020 | Year | 10 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033629
