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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000008928
Receipt No. R000010462
Scientific Title A randomized phase II trial of Pemetrexed or Pemetrexed plus Carboplatin followed by maintenance Pemetrexed therapy for elderly chemotherapy naive stage IIIB/IV or postoperative recurrence non-squamous non-small cell lung cancer patients
Date of disclosure of the study information 2012/09/19
Last modified on 2014/11/11

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Basic information
Public title A randomized phase II trial of Pemetrexed or Pemetrexed plus Carboplatin followed by maintenance Pemetrexed therapy for elderly chemotherapy naive stage IIIB/IV or postoperative recurrence non-squamous non-small cell lung cancer patients
Acronym A randomized phase II trial of Pemetrexed or Pemetrexed plus Carboplatin followed by maintenance Pemetrexed therapy for elderly chemotherapy naive stage IIIB/IV or postoperative recurrence non-squamous non-small cell lung cancer patients
Scientific Title A randomized phase II trial of Pemetrexed or Pemetrexed plus Carboplatin followed by maintenance Pemetrexed therapy for elderly chemotherapy naive stage IIIB/IV or postoperative recurrence non-squamous non-small cell lung cancer patients
Scientific Title:Acronym A randomized phase II trial of Pemetrexed or Pemetrexed plus Carboplatin followed by maintenance Pemetrexed therapy for elderly chemotherapy naive stage IIIB/IV or postoperative recurrence non-squamous non-small cell lung cancer patients
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 assess efficacy in elderly patients with previously untreated stageIII/VI or postoperative recurrence non-squamous non-small cell lung cancer treated with pemetrexed monotherapy or pemetrexed plus carboplatin combined therapy followed by maintenance pemetrexed therapy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Progression Free Survival (PFS)
Key secondary outcomes Response rate (RR), Disease control rate (DCR)
overall survival (OS), Safety

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Four cycles of Pemetrexed+ Carboplatin followed by maintenance Pemetrexed in 3 weeks cycles until progression disease
Interventions/Control_2 Four cycles of Pacritaxel followed by maintenance Pemetrexed in 3 weeks cycles until progression disease
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
75 years-old <=
Age-upper limit
85 years-old >
Gender Male and Female
Key inclusion criteria 1) Histologically or cytologically confirmed nonsqamous non-small cell lung cancer
2) Stage III/VI without any indications for radiotherapy, or recurrent disease after surgery
3) No prior chemotherapy or oral postoperative adjuvant chemotherapy stopped more than one month before
4) Patients who have measurable lesion
5) ECOG PS 0-1
6) Patients aged 75-84
7) No prior chemotherapy for primary lesion
8) No prior chemotherapy nor radiation therapy for other cancers
9) Patients are excepted to live at least 3 months
10) Adequate organ function, evaluated within 14 days before enrollment
WBC >=4,000/mm3
Neu >=2,000/mm3
Plt >=100,000/mm3
Hb>=9.0g/dl
AST<=100IU/l, /ALT<=100IU/l
T.Bil<=2.0mg/dl
sCr<=1.0mg/dl
SpO2>= 90% or PaO2>= 60torr
11) Written informed consent from the patients
Key exclusion criteria 1) Apparent interstitial pneumonia or pulmonary fibrosis detectable on Chest CT
2) Serious complications as follows;
1.Uncontrollable angina pectoris, acute myocardial infarction or congestive heart failue, etc within 1 year
2.Uncontrollable diabetes mellitus and hypertenson
3.Active infectious disease
4. intestinal paralysis or intestinal obstruction
5. Other Serious complications
3) Patiens has pleural effusion, pericardial effusion and ascites to need treatment
4) symptomatic brain metastasis
5) SVC syndrome
6) Active double cancer
7) Pregnancy, breast feeding and suspected or wish of pregnancy
8) Patients who have serious drug hypersensitivity reaction
9) Patients whose participation in the trial is judged to be inappropriate because of psychiatric disease or psychiatric symptoms
10) Patients whose participation in the trial is judged to be inappropriate by the attendeing doctor
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naohiko Inase
Organization Tokyo Medical and Dental university
Division name Department of Integrated Pulmonology
Zip code
Address 1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hiroyuki Sakashita
Organization Tokyo Medical and Dental university
Division name Department of Integrated Pulmonology
Zip code
Address 1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL
Homepage URL
Email

Sponsor
Institute Yushima Lung Cancer Oncology Group(YLOG)
Institute
Department

Funding Source
Organization Department of Integrated Pulmonology, Tokyo Medical and Dental 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
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

Other administrative information
Date of disclosure of the study information
2012 Year 09 Month 19 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 08 Month 27 Day
Date of IRB
Anticipated trial start date
2010 Year 12 Month 24 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
2012 Year 09 Month 15 Day
Last modified on
2014 Year 11 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010462

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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