UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002846 |
|---|---|
| Receipt number | R000003473 |
| Scientific Title | Phase II study of pematrexed plus carboplatin in previously untreated non-small cell, non-squamous cell lung cancer |
| Date of disclosure of the study information | 2009/12/04 |
| Last modified on | 2012/12/10 22:12:42 |
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Basic information
Public title
Phase II study of pematrexed plus carboplatin in previously untreated non-small cell, non-squamous cell lung cancer
Acronym
Phase II trial of PEM/CBDCA for NSCLC
Scientific Title
Phase II study of pematrexed plus carboplatin in previously untreated non-small cell, non-squamous cell lung cancer
Scientific Title:Acronym
Phase II trial of PEM/CBDCA for NSCLC
Region
| Japan |
Condition
Condition
Unresectable non-small cell lung cancer with EGFR mutations (non-squamous histology)
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluate efficacy and safety in combination of pemeterexed and carboplatin in non-small cell lung cancer (non-squamous histology)
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Response rate
Key secondary outcomes
safety, overall survival, and 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
Chemotherapy (Carboplatin + Pemetrexed)
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Histologically or cytologically proven NSCLC (non-squamous histology)
2) Chemotherapy-naive patients
3) Relapsed NSCLC without adjuvant chemotherapy is also eligible
4) Stage IIIB, IV NSCLC
5) At least one measurable lesion
6) Over 20 years old and under 75 years old
7) ECOG performance status of 0-1
8) Adequate organ functions (WBC >= 4,000 /mm3, Neutrophil >= 2,000 /mm3, Platelet >= 100,000 /mm3, Hemoglobin concentration >= 9.0 g/dl, AST or ALT <= 100 (<= 150 case with liver mets), T-bilirubin <= 1.5 mg/dl, Cr <= 1.2 mg/dl, creatinin clearance >= 60 ml/min, PaO2 or SpO2 >= 60 Torr or 95%)
9) Life expectancy of at least 12 weeks
10) Written informed consent
Key exclusion criteria
1) Active infection
2) fever >= 38C
3) Severe and uncontrolled complication 4) Other active malignancies
5) Unstable metastases to the brain
6) Uncontrolled pleural, pericardial effusion or ascites
7) Presence of active interstitial pneumonia
8) Allergy to treatment drugs
9) Pregnant patients
10) Unstable psychic disorder
11) Continuous use of steroid
12) Decision of ineligibility by a physician
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Ishida |
Organization
Fukushima Medicl University, School of Medicine
Division name
Pulmonary Medicine
Zip code
Address
960-1295 Hikarigaoka 1, Fukushima city
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Fukushima Medicl University, School of Medicine
Division name
Pulmonary Medicine
Zip code
Address
TEL
024-547-1111
Homepage URL
Sponsor or person
Institute
Hokkaido Lung Cancer Study Group
Institute
Department
Personal name
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
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 | 12 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Published
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 | 08 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 11 | 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
| 2009 | Year | 12 | Month | 04 | Day |
Last modified on
| 2012 | Year | 12 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003473
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
