UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000008937
Receipt No. R000010474
Scientific Title An exploratory study on efficacy and QOL of Pemetrexed plus Carboplatin followed by Pemetrexed in stage IIIB/IV or recurrent patients with non-squamous NSCLC without EGFR activating mutation.
Date of disclosure of the study information 2012/09/18
Last modified on 2020/03/29

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title An exploratory study on efficacy and QOL of Pemetrexed plus Carboplatin followed by Pemetrexed in stage IIIB/IV or recurrent patients with non-squamous NSCLC without EGFR activating mutation.
Acronym A study on efficacy and QOL of PEM plus CBDCA followed by PEM in patients with non-Sq NSCLC without EGFR activating mutation.
Scientific Title An exploratory study on efficacy and QOL of Pemetrexed plus Carboplatin followed by Pemetrexed in stage IIIB/IV or recurrent patients with non-squamous NSCLC without EGFR activating mutation.
Scientific Title:Acronym A study on efficacy and QOL of PEM plus CBDCA followed by PEM in patients with non-Sq NSCLC without EGFR activating mutation.
Region
Japan

Condition
Condition Non-squamous non-small cell lung cancer without EGFR activating mutation
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evalutate the correlation between delta QOL and PFS (or maintenance extraction rates) in stage IIIB/IV or recurrent patients with non-squamous NSCLC without EGFR activating mutation who receive Pemetrexed plus Carboplatin followed by Pemetrexed maintenance therapy.
delta QOL: the difference of QOL between prior to induction chemotherapy and prior maintenance chemotherapy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes PFS: Progression free Survival
Key secondary outcomes QOL:Quality of life
RR:Response rate
DCR:Disease control rate
OS:Overall survival
AE:Adverse events
Maintenance extraction rates
Progression free survival in cases given maintenance therapy

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 plus Carboplatin followed by Pemetrexed maintenance 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
80 years-old >
Gender Male and Female
Key inclusion criteria 1)Histologically or cytologically confirmed non-squamous non-small cell lung cancer without EGFR activating mutation
2)Recurrent or stage IIIB/IV non-squamous NSCLC patients unsuitable for radical irradiation
3)No prior chemotherapy, or recurrent patients finished adjuvantchemotherapy more than 6 months ago.
4)Measurable tumor sites
5)Karnofsky PS>=60
6)20 years old or older, younger than 80 years old at informed consent
7)Asymptomatic micro brain metastases can be enrolled.
Patients who received palliative radiotherapy to brain metastasis and/or bone metastasis 2 weeks or longer before chemotherapy.
A case who was given radiation therapy to primary lesion is not allowed.
8)No prior chemotherapy and radiotherapy for other cancer
9)Patients who are expected to survive for more than 3 months
10)Adequate organ function.
WBC count:>=4,000/mm3
neutrophil count:>=2,000/mm3
Platelet count:>=100,000/mm3
Hemoglobin:>=9.0g/dl
AST,ALT=<100IU/l
Total bilirubin:=<2.0mg/dl
creatinine:=<1.5mg/dl
Ccr>=45ml/min
PaO2>=60torr or SpO2>=90%
11)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 as follows.
2-1)Serious heart disease including uncontrollable angina pectoris, myocardial infarction within 3 months, and congestive heart failure.
2-2)Uncontrollable diabetes mellitus, hypertension.
2-3)Severe infection
2-4)Paresis of intestine, illeus
2-5)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 60

Research contact person
Name of lead principal investigator
1st name Kazuhisa
Middle name
Last name Takahashi
Organization Juntendo University Graduate School of Medicine
Division name Department of Respiratory Medicine
Zip code 113-8421
Address 2-1-1 Hongo Bunkyo-ku Tokyo-to 113-8421, Japan
TEL 03-5802-1063
Email kztakaha@juntendo.ac.jp

Public contact
Name of contact person
1st name Ryo
Middle name
Last name Koyama
Organization Juntendo University Graduate School of Medicine
Division name Department of Respiratory Medicine
Zip code 113-8421
Address 2-1-1 Hongo Bunkyo-ku Tokyo-to 113-8421, Japan
TEL 03-5802-1063
Homepage URL
Email rkoyama@juntendo.ac.jp

Sponsor
Institute Juntendo University Graduate School of Medicine
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Saitama Medical University International Medical Center
Toranomon Hospital
Kanagawa Cardiovascular and Respiratory Center
Name of secondary funder(s) none

IRB Contact (For public release)
Organization Not for public release
Address Not for public release
Tel non
Email non

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 順天堂大学医学部(東京都)
埼玉医科大学国際医療センター(埼玉県)
虎の門病院(東京都)
神奈川循環器呼吸器病センター(神奈川県)

Other administrative information
Date of disclosure of the study information
2012 Year 09 Month 18 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
2012 Year 03 Month 27 Day
Date of IRB
2012 Year 03 Month 23 Day
Anticipated trial start date
2012 Year 04 Month 01 Day
Last follow-up date
2017 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Prospective Study

Management information
Registered date
2012 Year 09 Month 18 Day
Last modified on
2020 Year 03 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010474

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.