UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005416 |
|---|---|
| Receipt number | R000006426 |
| Scientific Title | Induction chemoradiotherapy with cisplatin plus vinorelbine and irradiation, followed by surgery in cT1-3N2M0, stage IIIA non-small cell lung cancer. |
| Date of disclosure of the study information | 2011/05/01 |
| Last modified on | 2011/11/09 19:20:02 |
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Basic information
Public title
Induction chemoradiotherapy with cisplatin plus vinorelbine and irradiation, followed by surgery in cT1-3N2M0, stage IIIA non-small cell lung cancer.
Acronym
CDDP/VNR/RT and surgery for pN2 NSCLC
Scientific Title
Induction chemoradiotherapy with cisplatin plus vinorelbine and irradiation, followed by surgery in cT1-3N2M0, stage IIIA non-small cell lung cancer.
Scientific Title:Acronym
CDDP/VNR/RT and surgery for pN2 NSCLC
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology | Chest surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of the study is to analyze the efficacy and safety of induction chemotherapy with cisplatin and vinorelbine and irradiation, followed by resection in pathologically proven pN2-IIIA non-small cell lung cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Overall survival
Key secondary outcomes
3-yr recurrent-free survival, efficacy, percentage of accomplish surgical resection, percentage of adverse effects and severe adverse effects of the treatment
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
induction chemoradiotherapy and surgery
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
Resectable cN2-IIIA NSCLC
ECOG PS 0-1
Having measurable tumor
First treatment for the NSCLC
Neutrophil >= 1,500/mm3
Hemoglobin >= 10 g/dL
Platelet >= 100,000/mm3
GOT, GPT =< 2 * UNL
s-Cre =< 1/5 mg/dL
Written informed consent
Key exclusion criteria
Synchronous / metachronous double cancer
without in-situ carcinoma.
History of chest irradiation
Current severe infection
Severe cardiac and/or pulmonary diseases
Severe diabetes merritus
Steroid users
Female in pregnancy
Patients who is evaluated as "not suitable" for clinical trial by practitioners
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Date |
Organization
Kyoto University Hospital
Division name
Department of Thoracic Surgery
Zip code
Address
Shogoin Kawara-cho 54, Sakyo-ku, Kyoto Citiy
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Makoto Sonobe |
Organization
Kyoto University Hospital
Division name
Department of Thoracic Surgery
Zip code
Address
Shogoin Kawara-cho 54, Sakyo-ku, Kyoto Citiy
TEL
Homepage URL
msonobe-ths@umin.ac.jp
Sponsor or person
Institute
Kyoto University Hospital
Institute
Department
Personal name
Funding Source
Organization
Grant pool for research in department of thoracic surgery, Kyoto University Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
JAPAN
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
京都大学医学部附属病院（京都府）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 05 | Month | 01 | 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
| 2011 | Year | 04 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
| 2019 | Year | 05 | Month | 01 | Day |
Date trial data considered complete
| 2019 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2019 | Year | 10 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 04 | Month | 09 | Day |
Last modified on
| 2011 | Year | 11 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006426
