Unique ID issued by UMIN | UMIN000000599 |
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Receipt number | R000000697 |
Scientific Title | A phase II study of preoperative concurrent chemoradiotherapy with cisplatin and docetaxel in patients with locally advanced non-small-cell lung cancer |
Date of disclosure of the study information | 2007/02/08 |
Last modified on | 2019/08/22 16:45:31 |
A phase II study of preoperative concurrent chemoradiotherapy with cisplatin and docetaxel in patients with locally advanced non-small-cell lung cancer
A phase II study of preoperative concurrent chemoradiotherapy for
non-small-cell lung cancer
A phase II study of preoperative concurrent chemoradiotherapy with cisplatin and docetaxel in patients with locally advanced non-small-cell lung cancer
A phase II study of preoperative concurrent chemoradiotherapy for
non-small-cell lung cancer
Japan |
resectable locally advanced non small cell lung cancer
Pneumology | Surgery in general | Chest surgery |
Radiology |
Malignancy
NO
The present study is planned to assess the feasibility and effectiveness of the chemoradiotherapy as preoperative treatment in patients with stage IIIA or IIIB disease of which mediastinal lymph node metastasis is confirmed pathologically by mediastenoscopy.
Safety,Efficacy
Confirmatory
Phase II
3-year survival
the rate of complete resection
pathological response of preoperative therapy(down staging, pathological CR)
Progression free survival
toxicities
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine |
Two courses of chemotherapy with cisplatin (40 mg m-2) and docetaxel (40 mg m-2) with 3 weeks interval is planned. A total radiation dose of 40 Gy is planned with conventional fractionation (2 Gy day-). Patients undergo surgery 3 to 4 weeks after the end of second course of chemotherapy.
Not applicable |
75 | years-old | >= |
Male and Female
a) Pathological diagnosis of non-small cell lung cancer is necessary. Lesions should be surgically respectable.
b) Age = or < 70 years
c) No prior treatment for lung cancer
d) stage IIIA or IIIB with pathologically-proved mediastinal lymph node. Patients with mediastinal LN of shortest diameter of larger than 1 cm, T2-4, or CEA > 10ng/ml are required to undergo mediastinoscopy. Mediastinal lymph node biopsy should be done for bilateral #1-4, and #7.
e) Performance status (ECOG criteria) 0-1
f) Resection index should be more than 30.
g) No other primary cancers within past 5 years and no active cancers
h) Adequate bone marrow function
WBC more than 4000/ul, Granulocyte more than 2000/ul, Hg more than 10.0g/dl, Platelet count more than 100,000/ul.
i) Adequate liver function
(T.Bil less than 1.5mg/dl, AST/ALT less than 2.5 times of normal range.)
j) Adequate renal level. (serum creatinin less than 1.5mg/dl, Creatinine clearlance more than 60mg/dl)
k) Adequate pulmonary function
(PaO2 more than 70torr)
l) No other severe complications. Agreement for the protocol by physicians, surgeons and radiologists is essential.
m) Written informed consent to participate in the trial is necessary
a) Malignant pleuritis or malignant pericarditis.
b) Pleural dissemination.
c) Positive suplra calavicle nodes.
d) Active double cancer. The definition of inactive is that disease-free interval is more than 5 years. However, patients who have history of chemotherapy or thoracic irradiation are not acceptable.
e) Patients with severe complications.
1) Pulmonary fibrosis recognized with computed tomography scanning.
2)Severe heart disease.(Uncontrollable angina or myocardial infarction within the past 3 months)
3) Uncontrollable Diabetes Mellitus.
4) Severe infectious disease
5) Other unsuitable patient judged by a physician.
f) Women during pregnancy or lactating.
50
1st name | Shinichi |
Middle name | |
Last name | Toyooka |
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Department of Thoracic, Breast and Endocrine Surgery
700-8558
2-5-1 Shikata-cho, Kita-ku, Okayama, 700-8558, Japan
086-235-7265
toyooka@md.okayama-u.ac.jp
1st name | Hiromasa |
Middle name | |
Last name | Yamamoto |
Okayama University Hospital
Department of Thoracic Surgery
700-8558
2-5-1 Shikata-cho, Kita-ku, Okayama, 700-8558, Japan
086-235-7265
h.yamamoto@md.okayama-u.ac.jp
Setouchi Lung Cancer Group
none
Self funding
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee
2-5-1 Shikata-cho, Kita-ku, Okayama 700-8558, Japan
086-235-6938
mae6605@adm.okayama-u.ac.jp
NO
2007 | Year | 02 | Month | 08 | Day |
N/A
Unpublished
N/A
1
Unpublished
2019 | Year | 08 | Month | 22 | Day |
Unpublished
Unpublished
Unpublished
Unpublished
Terminated
2007 | Year | 01 | Month | 20 | Day |
2010 | Year | 10 | Month | 25 | Day |
2007 | Year | 01 | Month | 01 | Day |
2011 | Year | 12 | Month | 01 | Day |
2007 | Year | 02 | Month | 07 | Day |
2019 | Year | 08 | Month | 22 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000697
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