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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000004876
Receipt No. R000005804
Scientific Title Randomized phase II study of pemetrexed plus cisplatin or carboplatin followed by pemetrexed in chemotherapy-naive patients with non-squamous non-small cell lung cancer
Date of disclosure of the study information 2011/01/15
Last modified on 2015/08/14

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Basic information
Public title Randomized phase II study of pemetrexed plus cisplatin or carboplatin followed by pemetrexed in chemotherapy-naive patients with non-squamous non-small cell lung cancer
Acronym Randomized phase II study of pemetrexed plus cisplatin or carboplatin followed by pemetrexed in chemotherapy-naive patients with non-squamous non-small cell lung cancer
Scientific Title Randomized phase II study of pemetrexed plus cisplatin or carboplatin followed by pemetrexed in chemotherapy-naive patients with non-squamous non-small cell lung cancer
Scientific Title:Acronym Randomized phase II study of pemetrexed plus cisplatin or carboplatin followed by pemetrexed in chemotherapy-naive patients with non-squamous non-small cell lung cancer
Region
Japan

Condition
Condition non-squamous non-small cell lung cancer
Classification by specialty
Pneumology Hematology and clinical oncology Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 It verifies that PFS is 4.5 months or more in each arm.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes PFS: progression free survival

It verifies that PFS is 4.5 months or more in each arm.
Key secondary outcomes QOL: quality of life
RR: response rate
DCR: disease control rate
OS: overall survival
Maintenance treatment shift rate
AE: adverse events

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Pemetrexed after induction therapy of pemetrexed plus cisplatin
Interventions/Control_2 Pemetrexed after induction therapy of pemetrexed plus carboplatin
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
75 years-old >
Gender Male and Female
Key inclusion criteria 1)Histologically or cytologically confirmed non-squamous non-small cell lung cancer. (Non-Squamous NSCLC).
2)Stage III/IV unresectable or unsuitable for radical irradiation or postoperative recurrent Non-Squamous NSCLC.
3)No prior chemotherapy or post-operative recurrent disease without adjuvant chemotherapy or with at least six months interval from the last dosage of adjuvant chemotherapy.
4) Measurable tumor sites
5) ECOG-PS of 0 or 1.
6)No prior systemic anticancer therapy including palliative brain or bone irradiation within 2 weeks of proposed entry to this trial.
7) Life expectancy more than 3 months.
8) Adequate organ function.
9) Written informed consent from the patients.
Key exclusion criteria 1)Interstitial pneumonia or pulmonary fibrosis detectable on CT scan.
2)Patients with active co-morbidities including severe conditions.
(1)uncontrollable angina pectoris, myocardial infarction within 3 months, severe heart disease.
(2)uncontrollable diabetes, hypertension.
(3)severe infection
(4)paresis of intestine, illeus
(5)Patients whose participation in the trial is judged to be inappropriate by the attending doctor.
3)Patients with massive pleural and cardiac effusion and ascites that need to be immediately treated.
4) Brain metastases with neurological symptoms.
5) SVC syndrome.
6) Active double cancer.
7)Pregnancy, breast feeding and suspected pregnancy.
8)History of grave drug allergic reaction.
9) Psychiatric disorder.
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 Norihiko Ikeda
Organization Tokyo Medical University
Division name Department of Surgery
Zip code
Address 6-7-1 Nishi-shinjuku, Shinjuku-ku, Tokyo 160-0023, Japan.
TEL 03-3342-6111
Email ikeda-n@tokyo-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Seisuke Nagase
Organization International University of Health and Welfare
Division name Respiratory Disease Center
Zip code
Address 1-4-3 Mita, Minato-ku, Tokyo 108-8329, Japan.
TEL 03-3454-0067
Homepage URL
Email snagase@iuhw.ac.jp

Sponsor
Institute Tokyo Medical University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization None

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 慶応義塾大学病院 呼吸器内科(東京都)
至誠会第二病院 呼吸器内科(東京都)
聖路加国際病院 呼吸器内科(東京都)
東京医科歯科大学医学部附属病院 呼吸器内科(東京都)
東京女子医科大学病院 呼吸器内科(東京都)
日本医科大学付属病院 呼吸器内科(東京都)
複十字病院 呼吸器内科(東京都)
東京医療センター 呼吸器科(東京都)
日本赤十字社医療センター 化学療法科/呼吸器内科(東京都)
東京医科大学病院 呼吸器・甲状腺外科(東京都)

Other administrative information
Date of disclosure of the study information
2011 Year 01 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 Open public recruiting
Date of protocol fixation
2010 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 06 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 01 Month 14 Day
Last modified on
2015 Year 08 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005804

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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