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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000004635
Receipt No. R000005460
Scientific Title A Phase II first-line study of Carboplatin plus Pemetrexed in elderly patients with advanced non-small, non-squamous cell lung cancer
Date of disclosure of the study information 2010/12/01
Last modified on 2014/04/01

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Basic information
Public title A Phase II first-line study of Carboplatin plus Pemetrexed in elderly patients with advanced non-small, non-squamous cell lung cancer
Acronym A Phase II first-line study of CBDCA plus PEM in elderly patients with advanced non-small, non-squamous cell lung cancer
Scientific Title A Phase II first-line study of Carboplatin plus Pemetrexed in elderly patients with advanced non-small, non-squamous cell lung cancer
Scientific Title:Acronym A Phase II first-line study of CBDCA plus PEM in elderly patients with advanced non-small, non-squamous cell lung cancer
Region
Japan

Condition
Condition Non-Small, Non-Squamous Cell Lung Cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Objective of the study is to investigate efficacy and safety of carboplatin plus pemetexed for elderly patients with untreated non-small, non-squamous 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 response rate
Key secondary outcomes disease control rate, progression free survival, 1 year survival, safety, quality of life

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 combined chemotherapy with carboplatin plus pemetrexed
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 or cytologically proven non-small, non-squamous cell carcinoma.
2) Stage IIIb /IV patients with no prior chemotherapy and relapsed patients who previously received surgery. Relapsed patients after surgery who previously received only oral anti-tumor drug (excluding epidermal growth factor receptor tyrosine kinase inhibitor) as post operative adjuvant therapy. Palliative radiotherapy against tumors, which are not measurable lesions, is acceptable.
3) Patients aged 70 years or older.
4) Performance status (ECOG) 0-1
5) Sufficient function of main organ and bone marrow filled the following criteria:
Leukocyte counts, 3,000/mm3 or over.
Neutrophil counts, 1,500/mm3 or over.
Platelets, 100,000/mm3 or over.
Hemoglobin, 9.0 g/dl or over.
AST and ALT, x 2 of upper limit of normal (ULN) or less.
Total bilirubin, 1.5mg/dl or less.
Serum creatinin, x 1.5 of ULN or less.
No serious arrhythmia.
PaO2 60 Torr or above, or SpO2 90% or above.
No evident interstitial pneumonia
6) Patients who has at least one or more measurable lesion(s) by RECIST.
7) Patients who are considered to survive for more than 3 months.
8) Patients providing written informed consent.
Key exclusion criteria 1) Squamous cell carcinoma
2) Cases with previous radiation therapy against primary tumor
3) Patients with superior vena cava (SVC) syndrome
4) Patients with severe drug allergy
5) Patients with massive and/or uncontrollable pleural effusion
6) Patients with massive ascites, or pericardial effusion
7) Patients with active severe infections
8) Patients with active lung disease such as interstitial pneumonia or lung fibrosis
9) Patients with symptomatic brain metastasis
10) Patients with active concomitant malignancy
11) Patients with uncontrollable complications such as psychiatric problems
12) Inappropriate patients for this study judged by the physicians
Target sample size 35

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akihito Yokoyama
Organization Kochi University, School of Medicine
Division name Department of Hematology and Respiratory Medicine
Zip code
Address Kohasu, Okocho, Nankoku city, Kochi 783-8505, Japan
TEL 088-880-2345
Email im62@kochi-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tetsuya Kubota
Organization Kochi University, School of Medicine
Division name Department of Hematology and Respiratory Medicine
Zip code
Address Kohasu, Okocho, Nankoku city, Kochi 783-8505, Japan
TEL 088-880-2345
Homepage URL
Email im62@kochi-u.ac.jp

Sponsor
Institute Kochi University, School of Medicine, Department of Hematology and Resporatory Medicine
Institute
Department

Funding Source
Organization None
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 NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 高知大学医学部付属病院(高知県)、高知医療センター(高知県)、国立病院機構高知病院(高知県)、高知赤十字病院(高知県)

Other administrative information
Date of disclosure of the study information
2010 Year 12 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 Terminated
Date of protocol fixation
2010 Year 11 Month 25 Day
Date of IRB
Anticipated trial start date
2010 Year 12 Month 01 Day
Last follow-up date
2015 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 11 Month 30 Day
Last modified on
2014 Year 04 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005460

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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