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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Terminated |
Unique ID issued by UMIN | C000000146 |
Receipt No. | 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 |
Basic information | ||
Public title | Randomiazed controlled trial comparing docetaxel-cisplatin combination with docetaxel alone in elderly patients with advanced non-small-cell lung cancer(JCOG0207)
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Acronym | Cisplatin-containing combination vs single-agent chemotherapy in elderly patients with adavanced non-small-cell lung cancer (JCOG0207 Elderly NSCLC/D vs DP) | |
Scientific Title | Randomiazed controlled trial comparing docetaxel-cisplatin combination with docetaxel alone in elderly patients with advanced non-small-cell lung cancer(JCOG0207)
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Scientific Title:Acronym | Cisplatin-containing combination vs single-agent chemotherapy in elderly patients with adavanced non-small-cell lung cancer (JCOG0207 Elderly NSCLC/D vs DP) | |
Region |
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Condition | ||
Condition | non-small-cell lung cancer
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Classification by specialty |
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Classification by malignancy | Malignancy | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To evaluate the efficacy of docetaxel-cisplatin combination in comparison to docetaxel alone for elderly patients with advanced non-small-cell lung cancer.
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Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Confirmatory |
Trial characteristics_2 | |
Developmental phase | Phase III |
Assessment | |
Primary outcomes | overall survival
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Key secondary outcomes | Toxicity, Progression-free survival, Response rate, Symptom score
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Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Individual |
Blinding | Open -no one is blinded |
Control | Active |
Stratification | NO |
Dynamic allocation | YES |
Institution consideration | Institution is considered as adjustment factor in dynamic allocation. |
Blocking | NO |
Concealment | Central registration |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | Docetaxel alone administered by 3 consecutive weekly infusions | |
Interventions/Control_2 | Cispatin and docetaxel administered by 3 consecutive weekly infusions | |
Interventions/Control_3 | ||
Interventions/Control_4 | ||
Interventions/Control_5 | ||
Interventions/Control_6 | ||
Interventions/Control_7 | ||
Interventions/Control_8 | ||
Interventions/Control_9 | ||
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 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 |
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Key exclusion criteria | 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 |
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Target sample size | 230 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Niigata Cancer Center Hospital
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Division name | Department of internal medicine | ||||||
Zip code | |||||||
Address | 2-15-3 Kawagishi-cho, Niigata | ||||||
TEL | |||||||
Public contact | |||||||
Name of contact person |
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Organization | JCOG0207 Coordinating Office | ||||||
Division name | Department of internal medicine, Niigata Cancer Center Hospital | ||||||
Zip code | |||||||
Address | 2-15-3 Kawagishi-cho, Niigata | ||||||
TEL | 025-266-5111 | ||||||
Homepage URL | http://www.jcog.jp/ | ||||||
JCOG_sir@ml.jcog.jp |
Sponsor | |
Institute | Japan Clinical Oncology Group(JCOG)
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Institute | |
Department |
Funding Source | |
Organization | Ministry of Health, Labour and Welfare |
Organization | |
Division | |
Category of Funding Organization | |
Nationality of Funding Organization | Japan |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | |
Address | |
Tel | |
Secondary IDs | |
Secondary IDs | YES |
Study ID_1 | NCT00190476 |
Org. issuing International ID_1 | ClinicalTrials.gov by NLM |
Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
Institutions | |
Institutions | 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) |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Published |
Result | |
URL related to results and publications | http://www.ncbi.nlm.nih.gov/pubmed/25378648 |
Number of participants that the trial has enrolled | |
Results | 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 |
Results date posted | |
Results Delayed | |
Results Delay Reason | |
Date of the first journal publication of results | |
Baseline Characteristics | |
Participant flow | |
Adverse events | |
Outcome measures | |
Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Terminated | ||||||
Date of protocol fixation |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000211 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |