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 |
A phase 2 study of cisplatin plus pemetrexed followed by maintenance pemetrexed in unresectable malignant pleural mesothelioma
Cisplatin plus pemetrexed followed by maintenance pemetrexed in unresectable malignant pleural mesothelioma
A phase 2 study of cisplatin plus pemetrexed followed by maintenance pemetrexed in unresectable malignant pleural mesothelioma
Cisplatin plus pemetrexed followed by maintenance pemetrexed in unresectable malignant pleural mesothelioma
Japan |
malignant pleural mesothelioma
Pneumology |
Malignancy
NO
To evaluate efficacy and safety of cisplatin plus pemetrexed therapy and pemtrexed continuous maintenance therapy for inoperable malignant pleural mesothelioma
Safety,Efficacy
progression free survival from induction therapy
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine |
induction therapy: cisplatin plus pemetrexed
maintenance therapy: pemetrexed
20 | years-old | <= |
75 | years-old | > |
Male and Female
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
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
45
1st name | |
Middle name | |
Last name | Hiroshige Yoshioka |
Kurashiki Central Hospital
Department of Respiratory Medicine
1-1-1, Miwa, Kurashiki, Okayama
086-422-0210
hirotin@kchnet.or.jp
1st name | |
Middle name | |
Last name | Akihiro Nishiyama |
Kurashiki Central Hospital
Department of Respiratory Medicine
1-1-1, Miwa, Kurashiki, Okayama
086-422-0210
an11901@kchnet.or.jp
Kyoto Thoracic Oncology Research Group
None
Self funding
NO
2014 | Year | 09 | Month | 24 | Day |
Unpublished
Open public recruiting
2014 | Year | 09 | Month | 01 | Day |
2014 | Year | 09 | Month | 25 | Day |
2014 | Year | 09 | Month | 22 | Day |
2014 | Year | 12 | Month | 24 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017699