UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018138 |
|---|---|
| Receipt number | R000020996 |
| Scientific Title | A phase II trial of induction CDDP plus TS-1 with concurrent radiotherapy followed by surgical resection in patients with resectable stage IIIA-N2 non-small cell lung cancer |
| Date of disclosure of the study information | 2015/06/30 |
| Last modified on | 2019/07/04 05:26:13 |
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Basic information
Public title
A phase II trial of induction CDDP plus TS-1 with concurrent radiotherapy followed by surgical resection in patients with resectable stage IIIA-N2 non-small cell lung cancer
Acronym
A phase II trial of induction chemoradiotherapy followed by surgery in patients with resectable stage IIIA-N2 NSCLC
Scientific Title
A phase II trial of induction CDDP plus TS-1 with concurrent radiotherapy followed by surgical resection in patients with resectable stage IIIA-N2 non-small cell lung cancer
Scientific Title:Acronym
A phase II trial of induction chemoradiotherapy followed by surgery in patients with resectable stage IIIA-N2 NSCLC
Region
| Japan |
Condition
Condition
Stage IIIA-N2 non-small cell lung cancer
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To validate the safety and efficacy of induction CDDP plus TS-1 with concurrent radiotherapy followed by surgery in patients with stage IIIA-N2 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
2-year overall survival
Key secondary outcomes
Overall survival
Progression-free survival
Postoperative recurrence free survival
Response rate
Pathological complete response rate
Frequency and grade of adverse event
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 |
Interventions/Control_1
Induction concurrent chemoradiotherapy (CDDP +TS-1+ RT50Gy)
The surgical resection is performed after 2 cycles of chemotherapy with CDDP, TS-1 and RT50Gy.
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 cytologically proven non-small cell lung cancer, diagnosed using specimen material obtained from primary tumor or metastastatic lymph node
2)Stage IIIA- resectable N2 disease without previously treatment for lung cancer
3)Age>=20, <75 y
4)Patient who can ingest orally
5)ECOG PS 0-1
6)Adequate organ function
neutrophil count>=2,000/mm3
blood platelet count>=100,000/mm3
hemoglobin>=9.0g/dL
total bilirubin<=1.5mg/dL
AST,ALT<=100IU/L
PaO2>=60Torr or SpO2>=94%
CCr>=60ml/min
7)Written informed consent
Key exclusion criteria
1)History of active infection
2)Severe diarrhea
3)Severe complication
(Severe GI disease, bowel obstruction, interstitial pneumonia or pulmonary fibrosis detectable on chest Xp, uncontrollable diabetes mellitus, history of severe heart disease, severe renal disease, severe hepatic disease, Current history of GI ulcer, Current history of myocardial infarction and angina pectoris)
4)Autoimmune disease requiring immunosuppressive agent
5)History of active double cancer
6)History of pregnancy or lactation
7)History of psychiatric disorder
8)Systemic administration of steroid
9)Severe drug allergy
10) Hepatitis Bc antibody or hepatitis Bs antigen positive
11)Administration of flucytosine
12)Investigational new drug or the unapproved drug is administered
13)Any other medical condition that makes the patient unsuitable for inclusion in the study according to the opinion of the investigator
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kimihiro Shimizu |
Organization
Gunma University Hospital
Division name
General Thoracic Surgery, Integrative center of general surgery
Zip code
Address
3-39-15 Showa-machi, Maebashi, Gunma
TEL
027-220-8245
kmshimizu@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoichi Ohtaki |
Organization
Gunma University Hospital
Division name
General Thoracic Surgery, Integrative center of general surgery
Zip code
Address
3-39-15 Showa-machi, Maebashi, Gunma
TEL
027-220-8245
Homepage URL
yohtakiadvanced@gmail.com
Sponsor or person
Institute
Gunma University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
| 2015 | Year | 06 | Month | 30 | 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
| 2014 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2015 | Year | 07 | Month | 09 | Day |
Last follow-up date
| 2019 | Year | 12 | 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
| 2015 | Year | 06 | Month | 30 | Day |
Last modified on
| 2019 | Year | 07 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020996
