Unique ID issued by UMIN | UMIN000009407 |
---|---|
Receipt number | R000011050 |
Scientific Title | A combination phase I study of split doses of cisplatin plus etoposide with early concurrent accelerated hyperfractionated thoracic radiotherapy for elderly limited disease small cell lung cancer |
Date of disclosure of the study information | 2012/11/27 |
Last modified on | 2012/11/27 16:22:13 |
A combination phase I study of split doses of cisplatin plus etoposide with early concurrent accelerated hyperfractionated thoracic radiotherapy for elderly limited disease small cell lung cancer
A combination phase I study of split doses of cisplatin plus etoposide with early concurrent accelerated hyperfractionated thoracic radiotherapy for elderly limited disease small cell lung cancer
A combination phase I study of split doses of cisplatin plus etoposide with early concurrent accelerated hyperfractionated thoracic radiotherapy for elderly limited disease small cell lung cancer
A combination phase I study of split doses of cisplatin plus etoposide with early concurrent accelerated hyperfractionated thoracic radiotherapy for elderly limited disease small cell lung cancer
Japan |
limited disease small cell lung cancer
Hematology and clinical oncology |
Malignancy
NO
To estimate the maximum tolerable dose and recommended split dose of cisplatin and etoposide with early concurrent accelerated hyperfractionated thoracic radiotherapy, and to determine the efficacy and safety of the combination cisplatin and etoposide in elderly patients with limited disease small cell lung cancer
Safety
To estimate recommended split dose of cisplatin and etoposide with early concurrent accelerated hyperfractionated thoracic radiotherapy in elderly patients with limited disease small cell lung cancer
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
csiplatin, etoposide, thoratic radiation
70 | years-old | <= |
Not applicable |
Male and Female
1) SCLC
2) No prior treatment
3) limited disease SCLC
4) age>=70 years,Performance status (PS) of 0 to 1
5) At least one measurable lesion
6) Adequate main organ functions
7) Written informed consent
1)Severe infection and complication (hemorrhage and heart disease etc.)
2)Intestinal pneumonia or lung fibrosis
3)History of severe drug allergic reaction
4)Pregnant women or women willing child bearing
5)Men willing to have children
6)Uncontrolled diabetes
7)Uncontrolled pleural, cardiac, or abdominal effusion
8)Fever over 38 degrees Celsius
9)History of thoratic radiation
10)Inadequate condition diagnosed by primary physician
18
1st name | |
Middle name | |
Last name | Isamu Okamoto |
Kinki University faculty of Medicine
Department of Medical Oncology
377-2 Ohno-higashi, Osaka-Sayama, Osaka 589-8511, Japan
1st name | |
Middle name | |
Last name |
Kinki University faculty of Medicine
Department of Medical Oncology
377-2 Ohno-higashi, Osaka-Sayama, Osaka 589-8511, Japan
Department of Medical Oncology, Kinki University faculty of Medicine
Department of Medical Oncology, Kinki University faculty of Medicine
Self funding
NO
2012 | Year | 11 | Month | 27 | Day |
Unpublished
Open public recruiting
2008 | Year | 09 | Month | 11 | Day |
2008 | Year | 09 | Month | 12 | Day |
2012 | Year | 11 | Month | 27 | Day |
2012 | Year | 11 | Month | 27 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011050