UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010336 |
|---|---|
| Receipt number | R000012100 |
| Scientific Title | Feasibility study of adjuvant chemotherapy with cisplatin and pemetrexed short hydration regimen for completely resected NSCLC |
| Date of disclosure of the study information | 2013/04/01 |
| Last modified on | 2018/04/17 14:48:48 |
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Basic information
Public title
Feasibility study of adjuvant chemotherapy with cisplatin and pemetrexed short hydration regimen for completely resected NSCLC
Acronym
Feasibility study of adjuvant chemotherapy with cisplatin and pemetrexed short hydration regimen for completely resected NSCLC
Scientific Title
Feasibility study of adjuvant chemotherapy with cisplatin and pemetrexed short hydration regimen for completely resected NSCLC
Scientific Title:Acronym
Feasibility study of adjuvant chemotherapy with cisplatin and pemetrexed short hydration regimen for completely resected NSCLC
Region
| Japan |
Condition
Condition
Completely resected NSCLC(non-squamous cell carcinoma, stage II - IIIA)
Classification by specialty
| Pneumology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate feasibility of adjuvant chemotherapy with cisplatin and pemetrexed short hydration regimen for completely resected NSCLC (non-squamaous cell carcinoma) with staged II to IIIA.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Chemotherapy compliance in the four cycles
Key secondary outcomes
1.safety
2.extraction rate from hospitalization to outpatient clinic
3.2-years disease free survival
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
Dose:day1 CDDP 75mg/m2+PEM 500 mg/m2 with short hydration
Cycle: 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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1)The patient histologically proven as non-small cell lung cancer
(2)The patient with p-staged II - IIIA that received segmentectomy, lobectomy, or bi-lobectomy
(3) Performance Status is 0 - 1 (ECOG).
(4) 20 years of age or older, 75 years of age or younger.
(5) The patient who does not receive any chemotherapy, radiotherapy, or immunotherapy prior to resection
(6) The patient who preserves the main organ ( the bone marrow, liver, kidney and so on )
(7) The patient who can receive chemotherapy within 4 - 8 weeks after resection
(8) The patient who gives written informed consent
Key exclusion criteria
(1)The patient with infection
(2)The patient with fever (equal to or more than 38 C)
(3)The patient with heavy complication
(4)The patient with active double-cancer
(5)The patient with uncontrolled pleural effuson
(6)The patient with a motor-palsy or figure of peripheral-nerve-disease
(7)The patient with drug hypersensitivity
(8)The patient with common use of NSAIDs
(9)The expectant mother, the woman who has a lactating-woman and the possibility of the pregnancy
(10)The patient judged as unsuitable by the doctor
Target sample size
21
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Motoko Tachihara |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Respiratory Medicine, Department of Internal Medicine,
Zip code
Address
7-5-1, Kusunoki-Cho,Chuo-Ku, Kobe
TEL
078-382-5846
mt0318@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Motoko Tachihara |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Respiratory Medicine, Department of Internal Medicine,
Zip code
Address
7-5-1, Kusunoki-Cho,Chuo-Ku, Kobe
TEL
078-382-5846
Homepage URL
mt0318@med.kobe-u.ac.jp
Sponsor or person
Institute
Division of Respiratory Medicine, Department of Internal Medicine,Kobe University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Division of Respiratory Medicine, Department of Internal Medicine,Kobe University Graduate School of Medicine
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
| 2013 | Year | 04 | 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
Main results already published
Date of protocol fixation
| 2013 | Year | 03 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | 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
| 2013 | Year | 03 | Month | 28 | Day |
Last modified on
| 2018 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012100
