UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004634 |
|---|---|
| Receipt number | R000005528 |
| Scientific Title | The Phase II Study of Docetaxel plus Nedaplatin as Adjuvant Chemotherapy in Patients with Completely Resected Stage IB-IIIA Non-Small Cell Lung Cancer |
| Date of disclosure of the study information | 2010/11/30 |
| Last modified on | 2010/11/30 16:23:47 |
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Basic information
Public title
The Phase II Study of Docetaxel plus Nedaplatin as Adjuvant Chemotherapy in Patients with Completely Resected Stage IB-IIIA Non-Small Cell Lung Cancer
Acronym
The Phase II Study of Docetaxel plus Nedaplatin as Adjuvant Chemotherapy in Patients with Completely Resected Stage IB-IIIA Non-Small Cell Lung Cancer
Scientific Title
The Phase II Study of Docetaxel plus Nedaplatin as Adjuvant Chemotherapy in Patients with Completely Resected Stage IB-IIIA Non-Small Cell Lung Cancer
Scientific Title:Acronym
The Phase II Study of Docetaxel plus Nedaplatin as Adjuvant Chemotherapy in Patients with Completely Resected Stage IB-IIIA Non-Small Cell Lung Cancer
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 feasibility of docetaxel plus nedaplatin as adjuvant chemotherapy in patients with completely resected non-small cell lung cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Feasibility
Key secondary outcomes
Disease-free survival
Overall survival
Safety
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
| Medicine |
Interventions/Control_1
Docetaxel (60mg/m2) (day 1) +
Nedaplatin (80mg/m2) (day 1)
q4weeks, 4 cycles
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
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Histologically determined non-small cell lung cancer
2. Completely resected
3. Pathological stage IB, IIA, IIB, IIIA
4. Neither previous chemotherapy nor radiotherapy as adjuvant therapy
5. Aged 20-79 years old
6. ECOG performance status 0 or 1
7. Adequate organ function
8. Possible to receive chemotherapy within 4-8 months after surgery
9. Written informed consent
Key exclusion criteria
1. Allergy against polysorbert 80 or platinum-containing drugs
2. Severe complications
(i.e. ischemic heart diseases required treatment, arrhythmia, myocardial infarction within 6 months, liver cirrhosis, uncontrolled diabetes, hemorrhagic tendency)
3. Active infections
4. Massive pleural or pericardial effusion
5. Active simultaneous cancer
6. Active interstitial pneumonitis or its past history
6. Peripheral nerve disorders
7. Pregnant or lactating women
8. Other conditions not suitable for this study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Noriaki Tezuka |
Organization
Shiga University of Medical Science
Division name
Department of Surgery
Zip code
Address
Seta-Tsukinowa, Otsu, Shiga
TEL
077-548-2244
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koji Teramoto |
Organization
Shiga University of Medical Science
Division name
Department of Surgery
Zip code
Address
Seta-Tsukinowa, Otsu, Shiga
TEL
077-548-2244
Homepage URL
Sponsor or person
Institute
Shiga University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
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
滋賀医科大学医学部附属病院(滋賀県)
国立病院機構京都医療センター(京都府)
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 11 | 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
Enrolling by invitation
Date of protocol fixation
| 2010 | Year | 10 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 12 | 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
| 2010 | Year | 11 | Month | 30 | Day |
Last modified on
| 2010 | Year | 11 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005528
