UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008937 |
|---|---|
| Receipt number | 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 21:13:24 |
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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
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
rkoyama@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010474
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