Unique ID issued by UMIN | C000000136 |
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Receipt number | R000000202 |
Scientific Title | phase II study of gefitinib as a first-line therapy in elderly patients with lung adenocarcinoma. |
Date of disclosure of the study information | 2005/09/08 |
Last modified on | 2016/09/27 16:32:26 |
phase II study of gefitinib as a first-line therapy in elderly patients with lung adenocarcinoma.
phase II study of gefitinib as a first-line therapy in elderly patients with lung adenocarcinoma.
phase II study of gefitinib as a first-line therapy in elderly patients with lung adenocarcinoma.
phase II study of gefitinib as a first-line therapy in elderly patients with lung adenocarcinoma.
Japan |
lung adenocarcinoma
Hematology and clinical oncology |
Malignancy
NO
to evaluate the efficacy and safety of gefitinib as a first-line therapy in elderly patients with lung adenocarcinoma.
Safety,Efficacy
Phase II
Primary endpoint: response rate. Secondary endpoints: disease control rate, overall survival, time to progression, and toxicity.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Patients receive oral 250-mg gefitinib daily until disease progression.
70 | years-old | <= |
Not applicable |
Male and Female
1) primary lung adenocarcinoma; 2) stage IIIB or IV disease, unsuitable for radical thoracic radiation; 3) age of 70 years or older; 4) Eastern Cooperative Oncology Group performance status of 0 to 2; 5) no prior chemotherapy; 6) measurable lesions; 7) adequate organ fanctions; and 8) written informed consent.
1) interstitial pneumonitis or pulmonary fibrosis; 2) thoracic radiation within four weeks; 3) ongoing or planning palliative radiation; 4) symptomatic brain metastases; 5) uncontrolled pleural effusion; 6) pericardial effusion requiring drainage; 7) watery diarrhea; 8) serious underlying disease; 9) active concomitant malignancies; 10) a history of serious drug allergy; 11) clinically significant psychiatric disorder; and 12) unsuitable for entry to the study, decided by a medical oncologist.
30
1st name | |
Middle name | |
Last name | Kaoru Matsui (head), Masashi Kobayashi (secretariat) |
Osaka Prefectural Medical Center for Respiratory and Allergic Diseases
Department of Thoracic Malignancy
3-7-1 Habikino, Habikino-shi, Osaka 583-8588, Japan
0729-57-2121
1st name | |
Middle name | |
Last name | Masashi Kobayashi (secretariat) |
Osaka Prefectural Medical Center for Respiratory and Allergic Diseases
Department of Thoracic Malignancy
3-7-1 Habikino, Habikino-shi, Osaka 583-8588, Japan
0729-57-2121
West Japan Oncology Group
None
Self funding
NO
2005 | Year | 09 | Month | 08 | Day |
Published
http://www.ncbi.nlm.nih.gov/pubmed?term=21715363
Completed
2004 | Year | 11 | Month | 29 | Day |
2004 | Year | 12 | Month | 01 | Day |
2007 | Year | 12 | Month | 01 | Day |
2005 | Year | 09 | Month | 08 | Day |
2016 | Year | 09 | Month | 27 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000202
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