Unique ID issued by UMIN | UMIN000002586 |
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Receipt number | R000003105 |
Scientific Title | Phase I study of Pemetrexed/CDGP for advanced and relapsed NSCLC after thoracic surgery |
Date of disclosure of the study information | 2009/11/01 |
Last modified on | 2020/04/13 11:05:44 |
Phase I study of Pemetrexed/CDGP for advanced and relapsed NSCLC after thoracic surgery
Phase I study of Pemetrexed/CDGP chemptherapy
Phase I study of Pemetrexed/CDGP for advanced and relapsed NSCLC after thoracic surgery
Phase I study of Pemetrexed/CDGP chemptherapy
Japan |
Non-small cell lung cancer
Pneumology | Chest surgery |
Malignancy
NO
To evaluate the safety and feasibility of ALIMTA/CDGP combined chemotherapy
Safety
To determine the recommended dose of ALIMTA/CDGP combined chemotherapy
Interventional
Single arm
Non-randomized
Open -no one is blinded
Active
1
Treatment
Medicine |
chemotherapy
20 | years-old | <= |
75 | years-old | > |
Male and Female
Patients with histologically or cytologically confirmed NSCLC, who had not previously received any chemotherapy or radiotherapy, and relased after thoracic surgery. Other criteria included: 1) age >20 and <75 years; 2) Eastern Clinical Oncology Group (ECOG) performance status 0–1; 3) unresectable stage IIIb or IV disease; 4) adequate bone marrow function (neutrophil count >2 x 103/µl, hemoglobin 10 g/dl, platelet count > 10 x 10 4/µl), normal hepatic function (total bilirubin level < 1.5 mg/dl and AST < twice the upper normal limit), and renal function (serum creatinine <1.2 mg/dl, creatinine clearance > 60 ml/min). PO2 >60 torr.
1) interstitial pneumonia on chest XP, 2) pleural or pericardial effusion that required drainage, 3)neuropathy grade over 2, 4) systemic edema grade over 2, 5) severe heart disease, hypertension, DM, 6) active infection 7) active brain metastasis, or 8) pregnancy. 9) double cancers, 10) past history of hypersensitivity to drugs,
24
1st name | |
Middle name | |
Last name | Kazuo Yoshida |
Shinshu University
Departmant of Surgery, Respiratory Division
3-1-1 Asahi Matsumoto
1st name | |
Middle name | |
Last name |
Shinshu University
Respiratory Division
Shinshu University
nothing
Other
NO
2009 | Year | 11 | Month | 01 | Day |
Unpublished
Terminated
2009 | Year | 09 | Month | 07 | Day |
2009 | Year | 09 | Month | 08 | Day |
2009 | Year | 11 | Month | 01 | Day |
2011 | Year | 09 | Month | 01 | Day |
2009 | Year | 10 | Month | 05 | Day |
2020 | Year | 04 | Month | 13 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003105
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