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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002686
Receipt No. R000003273
Scientific Title A phase 2 study of cisplatin/pemetrexed followed by maintenance pemetrexed in patients with stage 3B or 4 non-squamous non-small-cell lung cancer.
Date of disclosure of the study information 2009/11/02
Last modified on 2013/05/29

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Basic information
Public title A phase 2 study of cisplatin/pemetrexed followed by maintenance pemetrexed in patients with stage 3B or 4 non-squamous non-small-cell lung cancer.
Acronym A phase 2 study of cisplatin/pemetrexed followed by maintenance pemetrexed in patients with stage 3B or 4 non-squamous non-small-cell lung cancer.
Scientific Title A phase 2 study of cisplatin/pemetrexed followed by maintenance pemetrexed in patients with stage 3B or 4 non-squamous non-small-cell lung cancer.
Scientific Title:Acronym A phase 2 study of cisplatin/pemetrexed followed by maintenance pemetrexed in patients with stage 3B or 4 non-squamous non-small-cell lung cancer.
Region
Japan

Condition
Condition Previously untreated stageIIIB/IV non-squamous non-small-cell lung cancer
Classification by specialty
Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of cisplatin and pemetrexed therapy followed by maintenance pemetrexed treatment
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes The proportion of patients who were progression free and on treatment at 6 months
Key secondary outcomes safety,progression free survival,1 year survival rate, response rate

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
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 cisplatin(75mg/m2)+pemetrexed(500mg/m2) followed by pemetrexed(500mg/m2)in 21-day cycles 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
74 years-old >=
Gender Male and Female
Key inclusion criteria 1)Histologically or cytologically confirned advanced non-squamous non-small-cell lung cancer (NSCLC)
2)With measurable lesion
3)Stage IIIB without any indications for radiotherapy or Stage IV or recurrent disease after surgery or radiotherapy who have no prior chemoterapy
4)less than 74 years old more than 20 years old
5)ECOG PS 0-1
6)Adequate organ function
7)Life expectancy more than 3 months
9)Signed informed consent
Key exclusion criteria 1)Histologically or cytologically confirned squamous cell lung cancer
2)Interstitial pneumonia or pulmonary fibrosis detectable on Chest X-ray
3) History of poorly controlled pleural effusion,pericardial effusion and ascites
4)Not appropriate to receive the folic acid and vitamin B12 formulation
5)SVC syndrome
6)Symptomatic brain metastases
7)History of active double cancer
8)Uncontrollable diabetes mellitus and hypertension
9)Diagnosed as liver cirrhosis by image findings or clinical laboratory
10)Suffers from an infectious disease to need antibiotic treatment
11)History of severe heart disease(uncontrollable arrythmia,uncontrollable angina pectoris,herat failure,etc within 6 months)
12)Pregnant female or sexually active males/females unwilling to use contraception during the protocol treatment
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)History of active psychological disease
17)Having the bleeding tendency which is clear in clinic
18)Taking continuous whole body administration (oral administration or intravenous administration) of steroid
19)Patients whose participation in the trial is judged to be inappropriate by the attending doctor
Target sample size 35

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shinji Atagi
Organization Kinki-chuo chest medical center
Division name medical oncology
Zip code
Address 1180 Nagasone-cho, Kita-ku, Sakai-city, Osaka591-8555 JAPAN
TEL 072-252-3021
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kazuhiro Asami
Organization Kinki-chuo chest medical center
Division name medical oncology
Zip code
Address 1180 Nagasone-cho, Kita-ku, Sakai-city, Osaka591-8555 JAPAN
TEL 072-252-3021
Homepage URL
Email

Sponsor
Institute Kinki-chuo chest medical center
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

Other administrative information
Date of disclosure of the study information
2009 Year 11 Month 02 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 10 Month 19 Day
Date of IRB
Anticipated trial start date
2009 Year 11 Month 01 Day
Last follow-up date
2012 Year 10 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
2009 Year 10 Month 29 Day
Last modified on
2013 Year 05 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003273

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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