UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008165 |
|---|---|
| Receipt number | R000009492 |
| Scientific Title | Randomized phase II trial of adjuvant chemotherapy with vinorelbine plus cisplatin versus S-1 plus carboplatin in patients with completely resected stage II/IIIA non-small cell lung cancer |
| Date of disclosure of the study information | 2012/06/13 |
| Last modified on | 2012/11/21 18:29:14 |
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Basic information
Public title
Randomized phase II trial of adjuvant chemotherapy with vinorelbine plus cisplatin versus S-1 plus carboplatin in patients with completely resected stage II/IIIA non-small cell lung cancer
Acronym
Adjuvant VNR+CDDP vs CBDCA+S-1 for Stage II/IIIA NSCLC
Scientific Title
Randomized phase II trial of adjuvant chemotherapy with vinorelbine plus cisplatin versus S-1 plus carboplatin in patients with completely resected stage II/IIIA non-small cell lung cancer
Scientific Title:Acronym
Adjuvant VNR+CDDP vs CBDCA+S-1 for Stage II/IIIA NSCLC
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of adjuvant VNR + CDDP and S-1 + CBDCA in patients with completely resected stage II-IIIA 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
Two year relapse-free survival rate
Key secondary outcomes
Overall Survival
Relapse-free Survival
Completion rate of protocol treatment
Safety
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
VNR 25mg/m2 day1,8
CDDP 40mg/m2 day1,8
q4W 4cycle
Interventions/Control_2
S-1 80-120mg/day day1-14
CBDCA AUC5 day1
q4W 4cycle
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 II-IIIA NSCLC
2)Completely resected NSCLC by lobectomy or more with lymph node dissection
3)No prior therapy without surgery for NSCLC
4)Age of 20 years or older
5)ECOG performance status 0-1
6)With adequate major organ functions within 14 days before randomization, as defined below:
*White blood cell count >= 3,500/mm3
*Neutrophil count >= 2,000/mm3
*Hemoglobin >= 9.0 g/dL
*Platelet count >= 100,000/mm3
*Total bilirubin <= 1.5 mg/dL
*AST <= 100IU/L
*ALT <= 100IU/L
*Creatinine <= 1.5 mg/dL
*CCr >= 60 mL/min
* SpO2 >= 92%
7) Be able to start adjuvant chemotherapy within 10 week after surgery
8)Written informed consent
Key exclusion criteria
1) Contraindication with S-1, carboplatin, vinorelbine and cisplatin
2) With large cell neuroendocrine carcinoma(LCNEC)
3) With interstitial pneumonitis or pulmonary fibrosis detectable on chest X-ray
4) With double cancer, multiple cancer
5) With Serious post-operative complications
6) With severe drug allergies
7) With serious concurrent disease
8) With serious diarrhea
9) Current use of flucytosine
10) Lactating, pregnant or possibly pregnant women, or those willing to become pregnant
11) Physician concludes that the patient's participation in this trial is inappropriate
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Suzuki |
Organization
Fukushima Medical University Hospital
Division name
Department of Chest Surgery
Zip code
Address
1 Hikariga-oka, Fukushima City, Fukushima Prefecture 960-1295 JAPAN
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Suzuki |
Organization
Fukushima Medical University Hospital
Division name
Department of Chest Surgery
Zip code
Address
1 Hikariga-oka, Fukushima City, Fukushima Prefecture 960-1295 JAPAN
TEL
024-547-1111
Homepage URL
Sponsor or person
Institute
Fukushima medical 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
福島県立医科大学附属病院 （福島県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 06 | Month | 13 | 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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 06 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 09 | Month | 01 | 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
| 2012 | Year | 06 | Month | 13 | Day |
Last modified on
| 2012 | Year | 11 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009492
