UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006139 |
|---|---|
| Receipt number | R000007260 |
| Scientific Title | Phase II Study of Pemetrexed in Combination with Carboplatin Followed by Pemetrexed Maintenance Therapy for Elderly Advanced Non-squamous and Non-small Cell Lung Cancer. |
| Date of disclosure of the study information | 2011/08/10 |
| Last modified on | 2012/03/09 12:57:53 |
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Basic information
Public title
Phase II Study of Pemetrexed in Combination with Carboplatin Followed by Pemetrexed Maintenance Therapy for Elderly Advanced Non-squamous and Non-small Cell Lung Cancer.
Acronym
Phase II Study of PEM/CBDCA Followed by PEM for elderly Non-squamous and Non-small Cell Lung Cancer.
Scientific Title
Phase II Study of Pemetrexed in Combination with Carboplatin Followed by Pemetrexed Maintenance Therapy for Elderly Advanced Non-squamous and Non-small Cell Lung Cancer.
Scientific Title:Acronym
Phase II Study of PEM/CBDCA Followed by PEM for elderly Non-squamous and Non-small Cell Lung Cancer.
Region
| Japan |
Condition
Condition
Non-squamous non-small-cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy and safety of Pemetrexed in Combination with Carboplatin Followed by Pemetrexed Maintenance Therapy for Elderly Advanced Non-squamous Non-small Cell Lung Cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
progression free survival
Key secondary outcomes
response rate, safety, overall survival, 1 year 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
PEM/CBDCA
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
| 70 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1)Histologically proven non-squamous non-small cell lung cancer
(2)Patient who has measurable lesion by RECIST
(3)Stage 3B/4 NSCLC
(4)ECOG performance status: 0-1
(5)Aged>=70 years
(6)No chemotherapy, radiotherapy, immunotherapy as prior therapy as for NSCLC
(7)Adequate organ functions
(8)Life expectancy >= 3 months
(9)Written informed consent
Key exclusion criteria
(1)Patients with other clinically significant complications; for example, uncontrollable diabetes and hypertension.
(2)Active severe infections.
(3)Patients with symptomatic brain metastasis .
(4)Patients with massive pleural or pericardial effusion.
(5)With prior unapproved drugs or investigational new drugs.
(6)Not appropriate to receive the folic acid and vitamin B12 formulation.
(7)With peripheral nerves >= grade 2 at enrollment.
(8)Continues to NSAIDs during this study.
(9)Inappropriate patients for this study judged by the physicians.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiki Ishii |
Organization
Dokkyo Medical University School of Medicine
Division name
Department of Pulmonary Medicine and Clinical Immunology
Zip code
Address
880 Kitakobayashi, Mibu, Tochigi, Japan
TEL
0282-87-2151
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Tochigi Thoracic Oncology Research Organization
Division name
Office
Zip code
Address
TEL
Homepage URL
ishiiysk@dokkyomed.ac.jp
Sponsor or person
Institute
Tochigi Thoracic Oncology Research Organization
Institute
Department
Personal name
Funding Source
Organization
Tochigi Thoracic Oncology Research Organization
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
| 2011 | Year | 08 | Month | 10 | 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 | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | 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
| 2011 | Year | 08 | Month | 09 | Day |
Last modified on
| 2012 | Year | 03 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007260
