UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015226 |
|---|---|
| Receipt number | R000017699 |
| Scientific Title | A phase 2 study of cisplatin plus pemetrexed followed by maintenance pemetrexed in unresectable malignant pleural mesothelioma |
| Date of disclosure of the study information | 2014/09/24 |
| Last modified on | 2014/12/24 20:20:44 |
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Basic information
Public title
A phase 2 study of cisplatin plus pemetrexed followed by maintenance pemetrexed in unresectable malignant pleural mesothelioma
Acronym
Cisplatin plus pemetrexed followed by maintenance pemetrexed in unresectable malignant pleural mesothelioma
Scientific Title
A phase 2 study of cisplatin plus pemetrexed followed by maintenance pemetrexed in unresectable malignant pleural mesothelioma
Scientific Title:Acronym
Cisplatin plus pemetrexed followed by maintenance pemetrexed in unresectable malignant pleural mesothelioma
Region
| Japan |
Condition
Condition
malignant pleural mesothelioma
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy and safety of cisplatin plus pemetrexed therapy and pemtrexed continuous maintenance therapy for inoperable malignant pleural mesothelioma
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
progression free survival from induction therapy
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
induction therapy: cisplatin plus pemetrexed
maintenance therapy: 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) Pathologically proven malignant pleural mesothelioma
2) No chemotherapy for mesothelioma
3) No indication for extrapleural pneumonectomy
4) Patients should be at least 20 years old and younger than 75 years old
5) ECOG performance status of 0 or 1
6) Functions of main organs are maintained, satisfying the following conditions
Neutrophil count >= 1,500/mm3
Platelet count >= 100,000/mm3
AST and ALT <= 100IU/L
Total bilirubin <= 1.5mg/dL
Serum creatinine <= 1.2 mg/dL
7) With expected prognosis more than 3 months
8) With written informed consent
Key exclusion criteria
1) With interstitial pneumonitis or pulmonary fibrosis which chest X-P can detect
2) With fluid accumulation which shoud be treated
3) With active double cancer
4) Patients who had already undergone cisplatin or pemetrexed
5) With poor-controled diabetes mellitus or hypertension
6) With liver cirrhosis diagnosed by imaging findings or clinical findings
7) History of severe heart disease (acute cardiac infarction or unstable angina within 6 months of registration, post-PTCA, post-CABG, sign of heart failure, uncontrollable arrythmia)
8) History of active infection
9) History of pregnancy or lactation
10) Sever drug allergy
11) No consent to blood transfusion
12) Evidence of bleeding tendency
13) No premedication of pemetrexed
14) Those judged to be not suitable by the attending physician
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshige Yoshioka |
Organization
Kurashiki Central Hospital
Division name
Department of Respiratory Medicine
Zip code
Address
1-1-1, Miwa, Kurashiki, Okayama
TEL
086-422-0210
hirotin@kchnet.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akihiro Nishiyama |
Organization
Kurashiki Central Hospital
Division name
Department of Respiratory Medicine
Zip code
Address
1-1-1, Miwa, Kurashiki, Okayama
TEL
086-422-0210
Homepage URL
an11901@kchnet.or.jp
Sponsor or person
Institute
Kyoto Thoracic Oncology Research 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
| 2014 | Year | 09 | Month | 24 | 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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 09 | Month | 25 | 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
| 2014 | Year | 09 | Month | 22 | Day |
Last modified on
| 2014 | Year | 12 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017699
