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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | No longer recruiting |
Unique ID issued by UMIN | UMIN000004368 |
Receipt No. | R000005222 |
Scientific Title | Multicenter phase II study of docetaxel/cisplatin/bevacizumab combination therapy in patients with advanced non-squamous non-small cell lung cancer (TORG1016) |
Date of disclosure of the study information | 2010/10/12 |
Last modified on | 2013/10/14 |
Basic information | ||
Public title | Multicenter phase II study of docetaxel/cisplatin/bevacizumab combination therapy in patients with advanced non-squamous non-small cell lung cancer (TORG1016) | |
Acronym | Multicenter phase II study of docetaxel/cisplatin/bevacizumab combination therapy in patients with advanced non-squamous non-small cell lung cancer (TORG1016) | |
Scientific Title | Multicenter phase II study of docetaxel/cisplatin/bevacizumab combination therapy in patients with advanced non-squamous non-small cell lung cancer (TORG1016) | |
Scientific Title:Acronym | Multicenter phase II study of docetaxel/cisplatin/bevacizumab combination therapy in patients with advanced non-squamous non-small cell lung cancer (TORG1016) | |
Region |
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Condition | ||
Condition | Non-small cell lung cancer | |
Classification by specialty |
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Classification by malignancy | Malignancy | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To investigate efficacy and safety of docetaxel/cisplatin/bevacizumab combination therapy in patients with non-squamous non-small cell lung cancer |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Exploratory |
Trial characteristics_2 | |
Developmental phase | Phase II |
Assessment | |
Primary outcomes | response rate |
Key secondary outcomes | adverse events, progression free survival, overall survival |
Base | |
Study type | Interventional |
Study design | |
Basic design | Single arm |
Randomization | Non-randomized |
Randomization unit | |
Blinding | Open -no one is blinded |
Control | Uncontrolled |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 1 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | docetaxel/cisplatin/bevacizumab combination therapy | |
Interventions/Control_2 | ||
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) pathologically diagnosed non-squamous non-small cell cancer
2) stage III/IV without indication for curative radiothrapy or post-operative reccurent disease 3) aged 20 years or older, under 75 years 4) ECOG PS: 0-1 5) measurable lesion meeting RECIST criteria (version 1.1) 6) no prior treatment except for surgery,EGFR-TKI, palliative radiotherapy 7) adequate organ function 8) life expectancy more than 3 months 9) adequate interval after prior treatments; 2 weeks from radiotherapy, 8 weeks from lobectomy, 4 weeks from exploratory thoracotomy, 2 weeks pleural drainage 10) written informed consent |
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Key exclusion criteria | 1) brain metastasis
2) histroy of hemoptysis 3) serious complication; cardiac disea se, interstitial peumonia, diabetes, active infection 4) massive pleural or pericardial effusion, ascites 5) concomitant malignancy 6) uncontrollable peptic ulcer or GI perforaion within 1 year 7) uncontrollable hypertension 8) anticoagulation therapy 9) inappropriate for this study judged by the attending physician |
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Target sample size | 47 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Kanagawa Cardiovascular and Respiratory Center | ||||||
Division name | Department of Respiratory Medicine | ||||||
Zip code | |||||||
Address | Tomioka-higashi 6-16-1, Kanazawa-ku, Yokohama, Japan | ||||||
TEL | 045-701-9581 | ||||||
Public contact | |||||||
Name of contact person |
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Organization | Kanagawa Cardiovascular and Respiratory Center | ||||||
Division name | Department of Respiratory Medicine | ||||||
Zip code | |||||||
Address | Tomioka-higashi 6-16-1, Kanazawa-ku, Yokohama, Japan | ||||||
TEL | 045-701-9581 | ||||||
Homepage URL | http://www.torg.or.jp/ | ||||||
t-kato@kanagawa-junko.jp |
Sponsor | |
Institute | Thoracic Oncology Research Group |
Institute | |
Department |
Funding Source | |
Organization | Thoracic Oncology Research Group |
Organization | |
Division | |
Category of Funding Organization | Self funding |
Nationality of Funding Organization | Japan |
Other related organizations | |
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Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | |
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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 | |
Date of the first journal publication of results | |
Baseline Characteristics | |
Participant flow | |
Adverse events | |
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Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | No longer recruiting | ||||||
Date of protocol fixation |
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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 | |
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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=R000005222 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |