UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003755 |
|---|---|
| Receipt number | R000004549 |
| Scientific Title | A Phase II study of Pemetrexed plus Carboplatin followed by maintenance Pemetrexed in patients with previously untreated stage III/IV or post-operative recurrent non-squamous non-small-cell and lung cancer. |
| Date of disclosure of the study information | 2010/06/15 |
| Last modified on | 2012/12/15 01:19:19 |
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Basic information
Public title
A Phase II study of Pemetrexed plus Carboplatin followed by maintenance Pemetrexed in patients with previously untreated stage III/IV or post-operative recurrent non-squamous non-small-cell and lung cancer.
Acronym
A Phase II study of Pemetrexed plus Carboplatin followed by maintenance Pemetrexed in patients with previously untreated stage III/IV or post-operative recurrent non-squamous non-small-cell and lung cancer.
Scientific Title
A Phase II study of Pemetrexed plus Carboplatin followed by maintenance Pemetrexed in patients with previously untreated stage III/IV or post-operative recurrent non-squamous non-small-cell and lung cancer.
Scientific Title:Acronym
A Phase II study of Pemetrexed plus Carboplatin followed by maintenance Pemetrexed in patients with previously untreated stage III/IV or post-operative recurrent non-squamous non-small-cell and lung cancer.
Region
| Japan |
Condition
Condition
Non-squamous non-small cell lung cancer
Classification by specialty
| Pneumology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy and safety of Pemetrexed plus Carboplatin followed by maintenance Pemetrexed in patients with previously untreated stage III/IV or post-operative recurrent non-squamous non-small-cell and lung cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
One year survival
Key secondary outcomes
Evaluation of safety,
Objective response rate,
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
Four cycles of Pemetrexed + Carboplatin followed by maintenance Pemetrexed 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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Histologically or cytologically confirmed non-sqamous non-small-cell lung cancer with Chemo-naive patients (Radiothrapy to any place other than primary and evaluable lesion is competent)
2) Patients who have measurable lesion (In 10mm Slice CT more than 20mm, in 5mm Slice CT more than 10mm) or evaluable lesion by RECIST
3) Stage III/IV without indication for curative resection and irradiation or post-operative recurrent disease without adjuvant chemotherapy or with at least one year interval from the last dosage of adjuvant chemotherapy
4) Patients aged 20 years or older
5) Karnofsky performance status 70-100
6) Adequate organ function, evaluated within 14 days before enrollment as;
WBC >= 4,000/mm3
Neu >= 2,000/mm3
Plt >= 100,000/mm3
Hb >= 9.5 g/dL
AST/ALT <= x 3 upper limit of normal range
T. Bil <= 1.5 g/dL
Ccr >= 60mL/min or sCr <= 1.2mg/dL
SpO2 >= 93% as room air
7) Excepted to live over 3 months after administration day
8) Written informed consent from the patients
Key exclusion criteria
Patients with at least one of the following conditions are ineligible
1) squamous cell carcinoma
2) Interstitial pneumonia or pulmonary fibrosis detectable on Chest X-ray
3) Pleural effusion, pericardial effusion and ascites to need treatment
4) Patients unable to take or unsupplied with folic acid and vitamin B12
5) Severe renal function disorder
6) SVC syndrome
7) Brain metastases with neurological symptoms
8) Active double cancer
9) Uncontrollable diabetes mellitus and hypertenson
10) Liver cirrhosis by image findings or laboratory examinations
11) History of severe heart disease (myocardial infarction within 6 months, unstable angina, post-PTCA or CAGB, signs of congestive heart failue, arrythmia with past history of heart failure, etc.)
12) Pregnancy, breast feeding and suspected pregnancy
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) Having the bleeding tendency which is clinically apparent
17) Patients whose participation in the trial is judged to be inappropriate by the attendeing doctor
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Kijima |
Organization
Osaka University Hospital
Division name
Dept. of Respiratory Medicine
Zip code
Address
2-2 Yamada-oka, Suita 565-0871, Osaka, Japan
TEL
06-6879-3833
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Kijima |
Organization
Osaka University Hospital
Division name
Dept. of Respiratory Medicine
Zip code
Address
2-2 Yamada-oka, Suita 565-0871, Osaka, Japan
TEL
06-6879-3833
Homepage URL
tkijima@imed3.med.osaka-u.ac.jp
Sponsor or person
Institute
Dept. of Respiratory Medicine,
Osaka University Hospital
Institute
Department
Personal name
Funding Source
Organization
Dept. of Respiratory Medicine,
Osaka University Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
OULCSG
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
| 2010 | Year | 06 | 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
Completed
Date of protocol fixation
| 2009 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2012 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2012 | Year | 11 | Month | 30 | Day |
Date analysis concluded
| 2012 | Year | 11 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 06 | Month | 14 | Day |
Last modified on
| 2012 | Year | 12 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004549
