UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025503 |
|---|---|
| Receipt number | R000029347 |
| Scientific Title | Feasibility study of local therapy including surgical resection in patients with clinical stageIV non-small cell lung cancer (NSCLC) who receive induction systemic therapy |
| Date of disclosure of the study information | 2017/01/04 |
| Last modified on | 2019/01/05 09:05:17 |
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Basic information
Public title
Feasibility study of local therapy including surgical resection in patients with clinical stageIV non-small cell lung cancer (NSCLC) who receive induction systemic therapy
Acronym
Feasibility study of local therapy including surgical resection in patients with clinical stageIV non-small cell lung cancer (NSCLC) who receive induction systemic therapy
Scientific Title
Feasibility study of local therapy including surgical resection in patients with clinical stageIV non-small cell lung cancer (NSCLC) who receive induction systemic therapy
Scientific Title:Acronym
Feasibility study of local therapy including surgical resection in patients with clinical stageIV non-small cell lung cancer (NSCLC) who receive induction systemic therapy
Region
| Japan |
Condition
Condition
lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology | Chest surgery |
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study evaluated the safety and efficacy of Salvage local therapy for the treatment in patients with clinical stageIV non-small cell lung cancer (NSCLC) who receive induction systemic therapy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1-year progression-free survival
Key secondary outcomes
2-year progression-free survival
Overall Survival
Safety
Post operative Quality of life
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
| Maneuver |
Interventions/Control_1
Operation
Radiation
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) Histologically or cytological proven clinical stage4 nonsmall cell carcinoma who receive induction systemic therapy.
2) Systemic therapy more than 12 months
3) Cases has a possibility of the radical cure resectability by lobectomy about the primary lesion at the maximum
4) Cases has a possibility of the radical therapy (surgery or radiation) about the metastatic lesion.
5) Adequate organ function.
6) Expected FEV 1.0 > 800ml after lung resection, SpO2 (Room air) >90% or PaO2 >= 65 torr.
7) Age >=20, <=75 y
8) ECOG PS 0-1
9) Cases indicating following organ (bone marrow, liver, kidney and lung) functions
10) Patients providing the written informed consent.
Key exclusion criteria
1) History of dissemination or malignant effusion.
2) Brain Metastasis with the severe symptom
3) Uncontrollable systemic disease (hyper tension, diabetes mellitus etc.)
4) History of active double cancer
5) History of active infection
6) Interstitial pneumonia or pulmonary fibrosis detectable on chest Xp
7) History of continuous steroidal treatment or Immunosuppressive drug.
8) Any other medical condition that makes the patient unsuitable for inclusion in the study according to the opinion of the investigator
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masafumi Kawamura |
Organization
Teikyo University school of Medicine
Division name
Surgery
Zip code
Address
2-11-1 Kaga, Itabashi-ku Tokyo
TEL
03-3964-1231
mkawamur@med.teikyo-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hirofumi Uehara |
Organization
Teikyo University school of Medicine
Division name
Surgery
Zip code
Address
2-11-1 Kaga, Itabashi-ku Tokyo
TEL
03-3964-1231
Homepage URL
hirofumi.uehara@med.teikyo-u.ac.jp
Sponsor or person
Institute
Teikyo University school of Medicine
Institute
Department
Personal name
Funding Source
Organization
Teikyo University school of Medicine
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
| 2017 | Year | 01 | Month | 04 | 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
| 2016 | Year | 11 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 01 | Month | 04 | 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 | 01 | Month | 03 | Day |
Last modified on
| 2019 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029347
