UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003948 |
|---|---|
| Receipt number | R000004746 |
| Scientific Title | Randomized phase II trial of UFT plus Cisplatin versus Pemetrexed plus Cisplatin combined with Concurrent Thoracic Radiotherapy in Locally Advanced Non-Small-Cell Lung Cancer. North Japan Lung Cancer Study Group Trial 1001 (NJLCG1001) |
| Date of disclosure of the study information | 2010/07/31 |
| Last modified on | 2011/03/31 13:06:31 |
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Basic information
Public title
Randomized phase II trial of UFT plus Cisplatin versus Pemetrexed plus Cisplatin combined with Concurrent Thoracic Radiotherapy in Locally Advanced Non-Small-Cell Lung Cancer.
North Japan Lung Cancer Study Group Trial 1001 (NJLCG1001)
Acronym
RDM PII UFT+CDDP+RT vs PEM+CDDP+RT
NJLCG1001
Scientific Title
Randomized phase II trial of UFT plus Cisplatin versus Pemetrexed plus Cisplatin combined with Concurrent Thoracic Radiotherapy in Locally Advanced Non-Small-Cell Lung Cancer.
North Japan Lung Cancer Study Group Trial 1001 (NJLCG1001)
Scientific Title:Acronym
RDM PII UFT+CDDP+RT vs PEM+CDDP+RT
NJLCG1001
Region
| Japan |
Condition
Condition
non-small-cell lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the efficacy and safety of UFT plus cisplatin versus pemetrexed plus cisplatin combined with concurrent thoracic radiotherapy in locally advanced 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
Two-years survival rate
Key secondary outcomes
response rate, progression free survival, overall survival, adverse events
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
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patients receive UFT (400mg/m2 per os) on day 1-14 and cisplatin (80mg/m2 div) on day8 every 3 weeks up to 3 cycles combined with concurrent thoracic radiotherapy (66Gy/33Fr)
Interventions/Control_2
Patients receive pemetrexed (500mg/m2 div) on day 1 and cisplatin (80mg/m2 div) on day1 every 3 weeks up to 3 cycles combined with concurrent thoracic radiotherapy (66Gy/33Fr)
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) Non-squamous non-small-cell lung cancer
2) Chemotherapy-naive
3) Radiotherapy-naive
4) Unresectable locally advanced clinical stage IIIA or IIIB
5) ECOG-PS 0 or 1
6) Measurable lesion by RECIST ver.1.1 criteria
7) Adequate organ function
8) Life expectancy more than 3 months
9) Written informed consent
Key exclusion criteria
1) Clinically active interstitial pneumonia or pulmonary fibrosis, detectable on CT scan
2) Malignant pleural or pericardial effusion or ascites
3) Severe co-morbidities (ex. uncontrolled heart or lung or hepatic or renal disease or diabetes)
4) Regular use of corticosteroid (less than 2 weeks interval after cessation)
5) Pregnancy or lactation, or those who decline contraception
6) Contraindication with chemotherapy or radiotherapy
7) Active concomitant malignancy. Except carcinoma in situ or those who did not relapse 5-years or more
8) Those judged to be not suitable by the attending physician
Target sample size
84
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makoto Maemondo |
Organization
Miyagi Cancer Center
Division name
Dept. of Respiratory Medicine
Zip code
Address
47-1 Nodayama, Medesima-shiote, Natori, Miyagi, Japan. 981-1293
TEL
022-384-3151
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akira Inoue |
Organization
Tohoku University Hospital
Division name
Dept. of Respiratory Medicine
Zip code
Address
TEL
Homepage URL
akinoue@idac.tohoku.ac.jp
Sponsor or person
Institute
Miyagi Cancer Center
Institute
Department
Personal name
Funding Source
Organization
Miyagi Cancer Center
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
YES
Study ID_1
NJLCG 1001
Org. issuing International ID_1
North Japan Lung Cancer Study Group
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 07 | Month | 31 | 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 | 07 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 08 | 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 | 07 | Month | 26 | Day |
Last modified on
| 2011 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004746
