Unique ID issued by UMIN | C000000146 |
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Receipt number | R000000211 |
Scientific Title | Randomiazed controlled trial comparing docetaxel-cisplatin combination with docetaxel alone in elderly patients with advanced non-small-cell lung cancer(JCOG0207) |
Date of disclosure of the study information | 2005/09/09 |
Last modified on | 2014/12/04 17:54:53 |
Randomiazed controlled trial comparing docetaxel-cisplatin combination with docetaxel alone in elderly patients with advanced non-small-cell lung cancer(JCOG0207)
Cisplatin-containing combination vs single-agent chemotherapy in elderly patients with adavanced non-small-cell lung cancer (JCOG0207 Elderly NSCLC/D vs DP)
Randomiazed controlled trial comparing docetaxel-cisplatin combination with docetaxel alone in elderly patients with advanced non-small-cell lung cancer(JCOG0207)
Cisplatin-containing combination vs single-agent chemotherapy in elderly patients with adavanced non-small-cell lung cancer (JCOG0207 Elderly NSCLC/D vs DP)
Japan |
non-small-cell lung cancer
Pneumology |
Malignancy
NO
To evaluate the efficacy of docetaxel-cisplatin combination in comparison to docetaxel alone for elderly patients with advanced non-small-cell lung cancer.
Efficacy
Confirmatory
Phase III
overall survival
Toxicity, Progression-free survival, Response rate, Symptom score
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
NO
YES
Institution is considered as adjustment factor in dynamic allocation.
NO
Central registration
2
Treatment
Medicine |
Docetaxel alone administered by 3 consecutive weekly infusions
Cispatin and docetaxel administered by 3 consecutive weekly infusions
70 | years-old | <= |
Not applicable |
Male and Female
1) histologically or cytologocally proven non-small-cell lung cancer
2) stage IV, or stage III disease ineligible for definitive radiotherapy
3) 70 years or older
4) ECOG PS 0-1
5) Ineligible for standard platinum(bolus infusion)-containing combination chemotherapy
6) No prior chemothrapy(containing gefitinib) for non-small cell lung cancer or other neoplasms
7) No prior surgery within 4weeks before enrollment
8) No prior radiotherapy for primary tumor
9) No prior radiotherapy for metastatic lesions within 2weeks before enrollment
10) Adequate organ function
11) Signed informed consent
1) Symptomatic brain metastasis
2) Active another neoplams
3) Severe SVC syndrome
4) Massive pericardial, pleural effusion, or ascites
5) Bone metastasis emergent for palliative radiotherapy or surgery
6) Uncontrollable systemic hypertension
7) Heart failure, Unstable angina Myocardial infarction within 6 months
8) Uncontrollable diabetes
9) Active infection
10) Interstitial pneumonia/ Pulmonary fibrosis
11) Hypersensitivity for polysolbate 80
12) Systemic administartion of corticosteroids
230
1st name | |
Middle name | |
Last name | Akira Yokoyama, MD, PhD |
Niigata Cancer Center Hospital
Department of internal medicine
2-15-3 Kawagishi-cho, Niigata
1st name | |
Middle name | |
Last name | Hiroko Tsukada, MD |
JCOG0207 Coordinating Office
Department of internal medicine, Niigata Cancer Center Hospital
2-15-3 Kawagishi-cho, Niigata
025-266-5111
http://www.jcog.jp/
JCOG_sir@ml.jcog.jp
Japan Clinical Oncology Group(JCOG)
Ministry of Health, Labour and Welfare
Japan
YES
NCT00190476
ClinicalTrials.gov by NLM
北海道がんセンター(北海道)
国立病院機構道北病院(北海道)
山形県立中央病院(山形県)
茨城県立中央病院(茨城県)
栃木県立がんセンター(栃木県)
国立病院機構西群馬病院(群馬県)
群馬県立がんセンター(群馬県)
埼玉県立がんセンター(埼玉県)
国立がんセンター東病院(千葉県)
国立がんセンター中央病院(東京都)
国立国際医療センター(東京都)
神奈川県立がんセンター(神奈川県)
横浜市立市民病院(神奈川県)
新潟県立がんセンター(新潟県)
岐阜市民病院(岐阜県)
静岡県立静岡がんセンター(静岡県)
愛知県がんセンター中央病院(愛知県)
愛知県がんセンター愛知病院(愛知県)
近畿大学医学部(大阪府)
大阪府立成人病センター(大阪府)
大阪府立呼吸器・アレルギー医療センター(大阪府)
近畿中央胸部疾患センター(大阪府)
刀根山病院(大阪府)
大阪市立総合医療センター(大阪府)
兵庫医科大学(兵庫県)
兵庫県立成人病センター(兵庫県)
四国がんセンター(愛媛県)
九州大学医学部附属病院(福岡県)
熊本地域医療センター(熊本県)
2005 | Year | 09 | Month | 09 | Day |
Published
http://www.ncbi.nlm.nih.gov/pubmed/25378648
See the datails via "URL releasing results" above.
Also the details can be seen in the JCOG website:
http://www.jcog.jp/en/trials/index.html
Terminated
2003 | Year | 03 | Month | 24 | Day |
2003 | Year | 04 | Month | 01 | Day |
2007 | Year | 02 | Month | 01 | Day |
2005 | Year | 09 | Month | 09 | Day |
2014 | Year | 12 | Month | 04 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000211
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