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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000008165
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Fukushima medical University Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009492

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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