UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000003948
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email

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
Email akinoue@idac.tohoku.ac.jp

Sponsor
Institute Miyagi Cancer Center
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004746

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.