Unique ID issued by UMIN | C000000087 |
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Receipt number | R000000138 |
Scientific Title | To evaluate whether two weekly concurrent chemoradiotherapy regimens offer any advantage over concurrent chemoradiotherapy regimens with Cisplatin, Vindesine, Mitomycin for unresectable stage III NSCLC |
Date of disclosure of the study information | 2005/08/29 |
Last modified on | 2015/08/31 15:33:26 |
To evaluate whether two weekly concurrent chemoradiotherapy regimens offer any advantage over concurrent chemoradiotherapy regimens with Cisplatin, Vindesine, Mitomycin for unresectable stage III NSCLC
To evaluate whether two weekly concurrent chemoradiotherapy regimens offer any advantage over concurrent chemoradiotherapy regimens with Cisplatin, Vindesine, Mitomycin for unresectable stage III NSCLC
To evaluate whether two weekly concurrent chemoradiotherapy regimens offer any advantage over concurrent chemoradiotherapy regimens with Cisplatin, Vindesine, Mitomycin for unresectable stage III NSCLC
To evaluate whether two weekly concurrent chemoradiotherapy regimens offer any advantage over concurrent chemoradiotherapy regimens with Cisplatin, Vindesine, Mitomycin for unresectable stage III NSCLC
Japan |
unresectable stage III NSCLC
Hematology and clinical oncology | Radiology |
Malignancy
NO
To evaluate whether two weekly concurrent chemoradiotherapy regimens offer any advantage over concurrent chemoradiotherapy regimens with Cisplatin, Vindesine, Mitomycin for unresectable stage III NSCLC
Safety,Efficacy
Phase III
Survival
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Uncontrolled
3
Treatment
Medicine |
arm A : The chemotherapy regimen consist of Cisplatin 80mg/m2 on day1 AND 29, Vindesine 3mg/m2 on day1,8, 29, and 36, Mitomycin 8mg/m2 on day1 and 29. The concurrent radiation consists of two, 30 gray courses separated by a 7-day rest period. Patients receive 2 courses of chemotherapy consist of Cisplatin, Vindesine, and Mitomycin as consolidation chemotherapy.
arm B: The chemotherapy regimen consists of Irinotecan 20mg/m2 and Carboplatin AUC2 administered weekly for 6 weeks. The concurrent radiation consists of 60 gray. Patients receive 2 courses of chemotherapy consist of Irinotecan and Carboplatin as consolidation chemotherapy.
arm C: The chemotherapy regimen consists of Paclitaxel 40mg/m2 and Carboplatin AUC2 administered weekly for 6 weeks. The concurrent radiation consists of 60 gray. Patients receive 2 courses of chemotherapy consist of Paclitaxel and Carboplatin as consolidation chemotherapy.
Not applicable |
75 | years-old | > |
Male and Female
All patients had histologocally or cytologically confirmed locally advanced NSCLC. All patients must not have undergone any previous therapy for NSCLC. Patients had to have measurable disease, an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1, and to be less than 75 years old. Adequate organ (bone marrow, renal, liver, heart, and lung) function was required. All patients gave written informed consent.
The exclusion criteria consisted of pulmonary fibrosis, pleural effusion, pregnancy, lactation, active concurrent malignancies, severe drug allergies, myocardial infarction, severe heart disease, uncontrollable diabetes mellitus, and infection.
450
1st name | |
Middle name | |
Last name | Hisao Uejima |
Rinku General Medical center
Department of Pulmonary Medicine
2-23, Rinku-Orai-Kita, Izumisano, Osaka 598-8577, Japan
0724-69-3111
1st name | |
Middle name | |
Last name | Shinichiro Nakamura |
West Japan Oncology Group
WJOG datacenter
2-23, Rinku-Orai-Kita, Izumisano, Osaka 598-8577, Japan
06-6633-7400
datacenter@wjog.jp
West Japan Oncology Group
None
Self funding
NO
2005 | Year | 08 | Month | 29 | Day |
Published
http://www.ncbi.nlm.nih.gov/pubmed?term=20625120
Completed
2001 | Year | 07 | Month | 21 | Day |
2001 | Year | 10 | Month | 01 | Day |
2006 | Year | 03 | Month | 01 | Day |
2010 | Year | 01 | Month | 01 | Day |
2005 | Year | 08 | Month | 29 | Day |
2015 | Year | 08 | Month | 31 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000138
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