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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | C000000310 |
Receipt No. | R000000400 |
Scientific Title | Docetaxel in combination with either cisplatin (DC) or gemcitabine (DG) in unresectable non-small sell lung carcinoma (NSCLC) |
Date of disclosure of the study information | 2006/01/23 |
Last modified on | 2007/03/26 |
Basic information | ||
Public title | Docetaxel in combination with either cisplatin (DC) or gemcitabine (DG) in unresectable non-small sell lung carcinoma (NSCLC) | |
Acronym | Docetaxel in combination with either cisplatin (DC) or gemcitabine (DG) in unresectable non-small sell lung carcinoma (NSCLC) | |
Scientific Title | Docetaxel in combination with either cisplatin (DC) or gemcitabine (DG) in unresectable non-small sell lung carcinoma (NSCLC) | |
Scientific Title:Acronym | Docetaxel in combination with either cisplatin (DC) or gemcitabine (DG) in unresectable non-small sell lung carcinoma (NSCLC) | |
Region |
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Condition | |||
Condition | Non-small sell lung carcinoma (NSCLC) | ||
Classification by specialty |
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Classification by malignancy | Malignancy | ||
Genomic information | NO |
Objectives | |
Narrative objectives1 | To assess the efficary of the Docetaxel + Gemcitabin (DG) regimen, and to determine if it is not inferior to the Docetaxel + Cisplatin (DC) regimen. |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase | Phase II |
Assessment | |
Primary outcomes | Response rate |
Key secondary outcomes | Survival (1-year survival rate)
Toxicity |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Individual |
Blinding | Open -no one is blinded |
Control | Active |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | The DC arm:
Doc(60mg/m2) day1 CDDP(80mg/m2) day1 Every 3 to 4 weeks |
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Interventions/Control_2 | The DG arm:
Doc(60mg/m2) day8 Gem(800mg/m2) day1,8 Every 3 to 4 weeks |
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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 proven NSCLC
2.Stage IIIB or IV 3.Measurable lesions by RECIST 4.No prior therapy 5.PS(ECOG) 0 or 1 6.Expected survival of more than 3 months 7.Preserved organ functions 8.Age of 20 to 75-year old 9.Written IC |
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Key exclusion criteria | 1.Proven or suspected infections diseases
2.Interstitial pneumonia (pulmonary fibrosis) manifested with chest radiogram and symptoms 3.Uncontrolable complications of heart, liver, DM, bleeding, etc. 4.Peripheral neuropathy of grade 2 or severer 5.Pleural fluid requiring treatment 6.Pericardial fluid 7.Symptomatic brain metastasis 8.Active concomitant malignancy 9.Pregnancy, breast feeding or wish of future bearing 10.History of drug allergy 11.Myocardial infarction within 3 months 12.Requirement of emergency radiotherapy 13.Other conditions not suitable for this study |
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Target sample size | 150 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | The Tokyo cooperative oncology group | ||||||
Division name | Chief director | ||||||
Zip code | |||||||
Address | 1-23-2 Hamamatsu-cho Minato-ku Tokyo Japan | ||||||
TEL | |||||||
Public contact | |||||||
Name of contact person |
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Organization | The Tokyo cooperative oncology group | ||||||
Division name | Secretariat | ||||||
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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 | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | |
Address | |
Tel | |
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 | Published |
Result | |
URL related to results and publications | http://www.jto.org/ |
Number of participants that the trial has enrolled | |
Results | |
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 | Completed | ||||||
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 |
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Date trial data considered complete |
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Date analysis concluded |
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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=R000000400 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |