UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002686 |
|---|---|
| Receipt number | R000003273 |
| Scientific Title | A phase 2 study of cisplatin/pemetrexed followed by maintenance pemetrexed in patients with stage 3B or 4 non-squamous non-small-cell lung cancer. |
| Date of disclosure of the study information | 2009/11/02 |
| Last modified on | 2013/05/29 09:33:46 |
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Basic information
Public title
A phase 2 study of cisplatin/pemetrexed followed by maintenance pemetrexed in patients with stage 3B or 4 non-squamous non-small-cell lung cancer.
Acronym
A phase 2 study of cisplatin/pemetrexed followed by maintenance pemetrexed in patients with stage 3B or 4 non-squamous non-small-cell lung cancer.
Scientific Title
A phase 2 study of cisplatin/pemetrexed followed by maintenance pemetrexed in patients with stage 3B or 4 non-squamous non-small-cell lung cancer.
Scientific Title:Acronym
A phase 2 study of cisplatin/pemetrexed followed by maintenance pemetrexed in patients with stage 3B or 4 non-squamous non-small-cell lung cancer.
Region
| Japan |
Condition
Condition
Previously untreated stageIIIB/IV non-squamous non-small-cell lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of cisplatin and pemetrexed therapy followed by maintenance pemetrexed treatment
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
The proportion of patients who were progression free and on treatment at 6 months
Key secondary outcomes
safety,progression free survival,1 year survival rate, response rate
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
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 cisplatin(75mg/m2)+pemetrexed(500mg/m2) followed by pemetrexed(500mg/m2)in 21-day cycles 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
| 74 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Histologically or cytologically confirned advanced non-squamous non-small-cell lung cancer (NSCLC)
2)With measurable lesion
3)Stage IIIB without any indications for radiotherapy or Stage IV or recurrent disease after surgery or radiotherapy who have no prior chemoterapy
4)less than 74 years old more than 20 years old
5)ECOG PS 0-1
6)Adequate organ function
7)Life expectancy more than 3 months
9)Signed informed consent
Key exclusion criteria
1)Histologically or cytologically confirned squamous cell lung cancer
2)Interstitial pneumonia or pulmonary fibrosis detectable on Chest X-ray
3) History of poorly controlled pleural effusion,pericardial effusion and ascites
4)Not appropriate to receive the folic acid and vitamin B12 formulation
5)SVC syndrome
6)Symptomatic brain metastases
7)History of active double cancer
8)Uncontrollable diabetes mellitus and hypertension
9)Diagnosed as liver cirrhosis by image findings or clinical laboratory
10)Suffers from an infectious disease to need antibiotic treatment
11)History of severe heart disease(uncontrollable arrythmia,uncontrollable angina pectoris,herat failure,etc within 6 months)
12)Pregnant female or sexually active males/females unwilling to use contraception during the protocol treatment
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)History of active psychological disease
17)Having the bleeding tendency which is clear in clinic
18)Taking continuous whole body administration (oral administration or intravenous administration) of steroid
19)Patients whose participation in the trial is judged to be inappropriate by the attending doctor
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinji Atagi |
Organization
Kinki-chuo chest medical center
Division name
medical oncology
Zip code
Address
1180 Nagasone-cho, Kita-ku, Sakai-city, Osaka591-8555 JAPAN
TEL
072-252-3021
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Asami |
Organization
Kinki-chuo chest medical center
Division name
medical oncology
Zip code
Address
1180 Nagasone-cho, Kita-ku, Sakai-city, Osaka591-8555 JAPAN
TEL
072-252-3021
Homepage URL
Sponsor or person
Institute
Kinki-chuo chest medical center
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 | 11 | Month | 02 | 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 | 10 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 10 | Month | 29 | Day |
Last modified on
| 2013 | Year | 05 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003273
