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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | C000000287 |
Receipt No. | R000000367 |
Scientific Title | A Phase III Study of Consolidation Chemotherapy Using UFT plus Cisplatin versus Docetaxel Following Concurrent Chemoradiotherapy for Locally Advanced Non-Small Cell Lung Cancer |
Date of disclosure of the study information | 2005/11/18 |
Last modified on | 2010/08/26 |
Basic information | ||
Public title | A Phase III Study of Consolidation Chemotherapy Using UFT plus Cisplatin versus Docetaxel Following Concurrent Chemoradiotherapy for Locally Advanced Non-Small Cell Lung Cancer | |
Acronym | A Phase III Study of Consolidation Chemotherapy Using UFT plus Cisplatin versus Docetaxel Following Concurrent Chemoradiotherapy for Locally Advanced Non-Small Cell Lung Cancer | |
Scientific Title | A Phase III Study of Consolidation Chemotherapy Using UFT plus Cisplatin versus Docetaxel Following Concurrent Chemoradiotherapy for Locally Advanced Non-Small Cell Lung Cancer | |
Scientific Title:Acronym | A Phase III Study of Consolidation Chemotherapy Using UFT plus Cisplatin versus Docetaxel Following Concurrent Chemoradiotherapy for Locally Advanced Non-Small Cell Lung Cancer | |
Region |
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Condition | ||
Condition | Locally Advanced Non-Small Cell Lung Cancer | |
Classification by specialty |
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Classification by malignancy | Malignancy | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | It compares by a Phase III Study of Consolidation Chemotherapy Using UFT plus Cisplatin versus Docetaxel Following Concurrent Chemoradiotherapy for Locally Advanced Non-Small Cell Lung Cancer |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase | Phase III |
Assessment | |
Primary outcomes | Survival |
Key secondary outcomes | Response rate, TTP, Safety, Compliance |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Individual |
Blinding | Open -no one is blinded |
Control | Active |
Stratification | YES |
Dynamic allocation | YES |
Institution consideration | Institution is considered as adjustment factor in dynamic allocation. |
Blocking | |
Concealment | Central registration |
Intervention | |||
No. of arms | 2 | ||
Purpose of intervention | Treatment | ||
Type of intervention |
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Interventions/Control_1 | UFT:400mg/m2,p.o.,d1-14,d29-42
Cisplatin:80mg/m2,div,d8,36 Radiation:2Gy*5days/week,d1-40, total 60Gy A: UFT:400mg/m2,p.o.,d1-14 Cisplatin: 80mg/m2,div,d8 every 3-4weeks |
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Interventions/Control_2 | UFT:400mg/m2,p.o.,d1-14,d29-42
Cisplatin:80mg/m2,div,d8,36 Radiation:2Gy*5days/week,d1-40, total 60Gy B: Docetaxel:60mg/m2,div,d1 every 3weeks |
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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 cytologically confirmed NSCLC
2) Measurable or evaluable disease, No prior chemotherapy ,Stage IIIA or IIIB 3) 75 years old or less 4) P.S.(ECOG) 0-1 5)Sufficient organ functions 6)Provided written informed consent. |
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Key exclusion criteria | 1)bronchopulmonary lymph node metastasis
2) Pleural or pericardial effusion requiring treatment 3) Concomitant malignancy 4) Serious concomitant disease 5)Apparent ineterstitial pneumonia or pulmonary fibrosis 6)Pregnant or lactation women, or women with known or suspected pregnancy. Man who wont let to pregnancy |
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Target sample size | 150 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | National Kyushu Cancer Center | ||||||
Division name | National Kyushu Cancer Center | ||||||
Zip code | |||||||
Address | 3-1-1 Notame Mimami-ku Fukuoka-shi Fukuoka Japan | ||||||
TEL | |||||||
Public contact | |||||||
Name of contact person |
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Organization | National Kyushu Cancer Center | ||||||
Division name | Respiratory | ||||||
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Sponsor | |
Institute | The Tokyo Cooperative Oncology Group |
Institute | |
Department |
Funding Source | |
Organization | The Tokyo Cooperative Oncology Group |
Organization | |
Division | |
Category of Funding Organization | Self funding |
Nationality of Funding Organization |
Other related organizations | |
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Name of secondary funder(s) |
IRB Contact (For public release) | |
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Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
Org. issuing International ID_1 | |
Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
Institutions | |
Institutions |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | |
Results | |
Results date posted | |
Results Delayed | |
Results Delay Reason | |
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Baseline Characteristics | |
Participant flow | |
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Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Completed | ||||||
Date of protocol fixation |
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Anticipated trial start date |
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Date analysis concluded |
Other | |
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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=R000000367 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |