UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006129 |
|---|---|
| Receipt number | R000007200 |
| Scientific Title | A randomized phase II study of pemetrexed versus pemetrexed plus carboplatin in chemotherapy-naive elderly patients with IIIB/IV non-squamous non-small cell lung cancer. |
| Date of disclosure of the study information | 2011/08/08 |
| Last modified on | 2013/10/24 12:42:37 |
* 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
A randomized phase II study of pemetrexed versus pemetrexed plus carboplatin in chemotherapy-naive elderly patients with IIIB/IV non-squamous non-small cell lung cancer.
Acronym
A randomized phase II study of MTA versus MTA plus CBDCA in elderly patients with IIIB/IV non-squamous NSCLC.
Scientific Title
A randomized phase II study of pemetrexed versus pemetrexed plus carboplatin in chemotherapy-naive elderly patients with IIIB/IV non-squamous non-small cell lung cancer.
Scientific Title:Acronym
A randomized phase II study of MTA versus MTA plus CBDCA in elderly patients with IIIB/IV non-squamous NSCLC.
Region
| Japan |
Condition
Condition
chemotherapy-naive elderly patients with IIIB/IV non-squamous non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy and safety of pemetrexed and pemetrexed plus carboplatin in chemotherapy-naive elderly patients with IIIB/IV non-squamous 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
6 months progression free survival rate
Key secondary outcomes
over all survival, response rate, safety, progression free survival without grade3/4 toxicity
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
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Pemetrexed 500mg/m2 Day1 q21days until PD
Interventions/Control_2
Pemetrexed 500mg/m2 Day1, Carboplatin AUC5 Day1 q21days*4cycles
Maintenance Pemetrexed 500mg/m2 Day1 q21days until PD
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
| 70 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Histologically or cytologically proven non-squamous non-small cell lung cancer
2)With measurable lesion
3)ECOG PS 0-1
4)Previously untreated stage IIIB/IV patients (no indication of surgery or radiotherapy)
5)70 years or older
6)Adequate organ function
7)Life expectancy more than 3 months
8)Written informed consent
Key exclusion criteria
1)Squamous cell carcinoma
2)Radiation therapy to primary cancer
3)SVC syndrome
4)Severe drug allergy
5)Massive or uncontrollable pleural effusion
6)Massive ascites, or pericardial effusion
7)Recurrence of postoperative NSCLC patients
8)Active infectious diseases
9)Interstitial pneumonia recognized by chest X-ray
10)CNS metastases with symptoms
11)Active multiple cancers
12)Psychological disorders
13)Inappropriate patients for this study judged by the physicians
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Eiji Shimizu |
Organization
Faculty of Medicine, Tottori University
Division name
Division of Medical Oncology and Molecular Respirology
Zip code
Address
36-1 Nishi-machi, Yonago-shi, Tottori-ken 683-0805
TEL
0859-38-6537
htouge3@med.tottori-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hirokazu Touge |
Organization
Faculty of Medicine, Tottori University
Division name
Division of Medical Oncology and Molecular Respirology
Zip code
Address
36-1 Nishi-machi, Yonago-shi, Tottori-ken 683-0805
TEL
0859-38-6537
Homepage URL
htouge3@med.tottori-u.ac.jp
Sponsor or person
Institute
Division of Medical Oncology and Molecular Respirology, Department of Multidisciplinary Internal Medicine, Faculty of Medicine, Tottori University
Institute
Department
Personal name
Funding Source
Organization
Division of Medical Oncology and Molecular Respirology, Department of Multidisciplinary Internal Medicine, Faculty of Medicine, Tottori University
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
鳥取大学医学部附属病院、鳥取県立中央病院、松江赤十字病院、米子医療センター、松江医療センター、松江市立病院
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 08 | Month | 08 | 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
| 2011 | Year | 04 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 05 | 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
| 2011 | Year | 08 | Month | 08 | Day |
Last modified on
| 2013 | Year | 10 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007200
