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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003755
Receipt No. R000004549
Scientific Title A Phase II study of Pemetrexed plus Carboplatin followed by maintenance Pemetrexed in patients with previously untreated stage III/IV or post-operative recurrent non-squamous non-small-cell and lung cancer.
Date of disclosure of the study information 2010/06/15
Last modified on 2012/12/15

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Basic information
Public title A Phase II study of Pemetrexed plus Carboplatin followed by maintenance Pemetrexed in patients with previously untreated stage III/IV or post-operative recurrent non-squamous non-small-cell and lung cancer.
Acronym A Phase II study of Pemetrexed plus Carboplatin followed by maintenance Pemetrexed in patients with previously untreated stage III/IV or post-operative recurrent non-squamous non-small-cell and lung cancer.
Scientific Title A Phase II study of Pemetrexed plus Carboplatin followed by maintenance Pemetrexed in patients with previously untreated stage III/IV or post-operative recurrent non-squamous non-small-cell and lung cancer.
Scientific Title:Acronym A Phase II study of Pemetrexed plus Carboplatin followed by maintenance Pemetrexed in patients with previously untreated stage III/IV or post-operative recurrent non-squamous non-small-cell and lung cancer.
Region
Japan

Condition
Condition Non-squamous non-small cell lung cancer
Classification by specialty
Pneumology Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the efficacy and safety of Pemetrexed plus Carboplatin followed by maintenance Pemetrexed in patients with previously untreated stage III/IV or post-operative recurrent non-squamous non-small-cell and lung cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes One year survival
Key secondary outcomes Evaluation of safety,
Objective response rate,
Progression Free 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 Four cycles of Pemetrexed + Carboplatin followed by maintenance Pemetrexed until disease progression
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Histologically or cytologically confirmed non-sqamous non-small-cell lung cancer with Chemo-naive patients (Radiothrapy to any place other than primary and evaluable lesion is competent)
2) Patients who have measurable lesion (In 10mm Slice CT more than 20mm, in 5mm Slice CT more than 10mm) or evaluable lesion by RECIST
3) Stage III/IV without indication for curative resection and irradiation or post-operative recurrent disease without adjuvant chemotherapy or with at least one year interval from the last dosage of adjuvant chemotherapy
4) Patients aged 20 years or older
5) Karnofsky performance status 70-100
6) Adequate organ function, evaluated within 14 days before enrollment as;
WBC >= 4,000/mm3
Neu >= 2,000/mm3
Plt >= 100,000/mm3
Hb >= 9.5 g/dL
AST/ALT <= x 3 upper limit of normal range
T. Bil <= 1.5 g/dL
Ccr >= 60mL/min or sCr <= 1.2mg/dL
SpO2 >= 93% as room air
7) Excepted to live over 3 months after administration day
8) Written informed consent from the patients
Key exclusion criteria Patients with at least one of the following conditions are ineligible
1) squamous cell carcinoma
2) Interstitial pneumonia or pulmonary fibrosis detectable on Chest X-ray
3) Pleural effusion, pericardial effusion and ascites to need treatment
4) Patients unable to take or unsupplied with folic acid and vitamin B12
5) Severe renal function disorder
6) SVC syndrome
7) Brain metastases with neurological symptoms
8) Active double cancer
9) Uncontrollable diabetes mellitus and hypertenson
10) Liver cirrhosis by image findings or laboratory examinations
11) History of severe heart disease (myocardial infarction within 6 months, unstable angina, post-PTCA or CAGB, signs of congestive heart failue, arrythmia with past history of heart failure, etc.)
12) Pregnancy, breast feeding and suspected pregnancy
13) History of grave drug allergic reaction
14) Acute inflammatory disease
15) An agreement is not obtained for support therapy such as transfusion etc
16) Having the bleeding tendency which is clinically apparent
17) Patients whose participation in the trial is judged to be inappropriate by the attendeing doctor
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Kijima
Organization Osaka University Hospital
Division name Dept. of Respiratory Medicine
Zip code
Address 2-2 Yamada-oka, Suita 565-0871, Osaka, Japan
TEL 06-6879-3833
Email

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Kijima
Organization Osaka University Hospital
Division name Dept. of Respiratory Medicine
Zip code
Address 2-2 Yamada-oka, Suita 565-0871, Osaka, Japan
TEL 06-6879-3833
Homepage URL
Email tkijima@imed3.med.osaka-u.ac.jp

Sponsor
Institute Dept. of Respiratory Medicine,
Osaka University Hospital
Institute
Department

Funding Source
Organization Dept. of Respiratory Medicine,
Osaka University Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor OULCSG
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
2010 Year 06 Month 15 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 Completed
Date of protocol fixation
2009 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 01 Month 01 Day
Last follow-up date
2012 Year 11 Month 30 Day
Date of closure to data entry
2012 Year 11 Month 30 Day
Date trial data considered complete
2012 Year 11 Month 30 Day
Date analysis concluded
2012 Year 11 Month 30 Day

Other
Other related information

Management information
Registered date
2010 Year 06 Month 14 Day
Last modified on
2012 Year 12 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004549

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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