Unique ID issued by UMIN | C000000116 |
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Receipt number | R000000172 |
Scientific Title | randomized study of Gemicitabine alone or UFT adjuvant chemotherapy for stage IB-IIIA non small cell lung cancer after complete resection |
Date of disclosure of the study information | 2005/09/06 |
Last modified on | 2019/01/29 18:06:35 |
randomized study of Gemicitabine alone or UFT adjuvant chemotherapy for
stage IB-IIIA non small cell lung cancer after complete resection
randomized study of Gemicitabine alone or UFT adjuvant chemotherapy for
stage IB-IIIA non small cell lung cancer after complete resection
randomized study of Gemicitabine alone or UFT adjuvant chemotherapy for
stage IB-IIIA non small cell lung cancer after complete resection
randomized study of Gemicitabine alone or UFT adjuvant chemotherapy for
stage IB-IIIA non small cell lung cancer after complete resection
Japan |
stage IB-IIIA non small cell lung cancer after complete resection
Hematology and clinical oncology |
Malignancy
NO
To estimate the efficacy of Gemcitabine monotherapy compared to UFT as the
post operative adjuvant chemotherapy for completely resected non-small cell
lung cancer
Efficacy
Phase III
overall survival
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
2
Treatment
Medicine |
experimental arm: gemicitabine 1000mg/m2, day1 and day 8, every 3 week, 6
cycle
standard arm: UFT 250mg/m2, daily for 1 year
20 | years-old | <= |
75 | years-old | >= |
Male and Female
1.completely resected non small cell lung cancer
2.no prior anti cancer treatment for thoracic malignancy exept for this
operation
3.pathological stage IB, II, and stage IIIA with only one station of n2
disease
4.PS 0-1
5.age 20-75
6.adequate oragan function for chemotherapy
7.written informed consent
1.small cell lung cancer or low grade malignancy of lung cancer
2.incomplete resection
3.apparant interstitial pneumonitis at chest rentogenogram
4.inadequate conditon for chemotherapy
600
1st name | |
Middle name | |
Last name | Hirohito Tada, MD. |
Osaka City General Hospital
Division of Thoracic Surgery
Miyakojima Hondhori 2-13-22
1st name | |
Middle name | |
Last name | Shinichiro Nakamura |
West Japan Oncology Group
WJOG datacenter
06-6633-7400
datacenter@wjog.jp
West Japan Oncology Group
None
Self funding
NO
2005 | Year | 09 | Month | 06 | Day |
Partially published
Main results already published
2001 | Year | 04 | Month | 28 | Day |
2001 | Year | 06 | Month | 01 | Day |
2010 | Year | 12 | Month | 01 | Day |
2005 | Year | 09 | Month | 06 | Day |
2019 | Year | 01 | Month | 29 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000172
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