Unique ID issued by UMIN | UMIN000001743 |
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Receipt number | R000002102 |
Scientific Title | Phase II study of high-dose thoracic 3D-conformal radiotherapy without elective nodal irradiation concurrently combined with cisplatin and vinorelbine chemotherapy in patients with inoperable stage III non-small cell lung cancer |
Date of disclosure of the study information | 2009/03/02 |
Last modified on | 2011/11/13 21:32:35 |
Phase II study of high-dose thoracic 3D-conformal radiotherapy without elective nodal irradiation concurrently combined with cisplatin and vinorelbine chemotherapy in patients with inoperable stage III non-small cell lung cancer
Phase II study of high-dose thoracic and cisplatin and vinorelbine for stage III NSCLC
Phase II study of high-dose thoracic 3D-conformal radiotherapy without elective nodal irradiation concurrently combined with cisplatin and vinorelbine chemotherapy in patients with inoperable stage III non-small cell lung cancer
Phase II study of high-dose thoracic and cisplatin and vinorelbine for stage III NSCLC
Japan |
inoperable stage III non-small cell lung cancer
Pneumology | Hematology and clinical oncology | Radiology |
Malignancy
NO
To evaluate efficacy and safety of high-dose thoracic radiotherapy concurrently combined with cisplatin and vinorelbine chemotherapy for inoperable stage III non-small cell lung cancer
Safety,Efficacy
Exploratory
Explanatory
Phase II
2-year survival rate
Response rate, overall survival, incidence of toxicity
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Cisplatin 80mg/m2 on day 1 + vinorelbine 20mg/m2 on days 1 and 8, repeated every 4 weeks for 4 cycles,
Thoracic radiotherapy 72 Gy/36 fractions
20 | years-old | <= |
74 | years-old | >= |
Male and Female
1. a histological or cytological diagnosis of NSCLC; 2. inoperable clinical stage III; 3. no prior treatment; 4. measurable disease; 5. the percent volume of the normal lung receiving 20 Gy or more (V20) equal to or less than 30%; 6. age between 20 and 74 years; 7. Performance Status of 0 - 1; 8. adequate organ function; and 9. written informed consent.
1. malignant pleural or pericardial effusion; 2. contralateral hilar lymph node metastasis, intralobular metastasis or lymphangitis carcinomatosa; 3. serious concomitant medical illness; 4. synchronous active malignancies; 5. history of chemotherapy or thoracic radiotherapy; 6. pregnancy or breast feeding.
60
1st name | |
Middle name | |
Last name | Tomohide Tamura |
National Cancer Center Hospital
Division of Internal Medicine and Thoracic Oncology
Tsukiji 5-1-1, Chuo-ku, Tokyo
03-3542-2511
1st name | |
Middle name | |
Last name | Ikuo Sekine |
National Cancer Center Hospital
Division of Internal Medicine and Thoracic Oncology
Tsukiji 5-1-1, Chuo-ku, Tokyo
03-3542-2511
isekine@ncc.go.jp
National Cancer Center Hospital
none
Hyogo Cancer Center
KKR Sapporo Medical Center
National Hospital Organization Hokkaido Cancer Center
Tochigi Cancer Center
NO
2009 | Year | 03 | Month | 02 | Day |
Unpublished
Suspended
2009 | Year | 01 | Month | 13 | Day |
2009 | Year | 03 | Month | 01 | Day |
2014 | Year | 02 | Month | 01 | Day |
2009 | Year | 03 | Month | 01 | Day |
2011 | Year | 11 | Month | 13 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002102
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