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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000005585 |
Receipt No. | R000006512 |
Official scientific title of the study | Dose-escalation study of proton beam therapy with chemotherapy for locally advanced non-small lung cancer |
Date of disclosure of the study information | 2011/05/12 |
Last modified on | 2016/04/23 |
Basic information | ||
Official scientific title of the study | Dose-escalation study of proton beam therapy with chemotherapy for locally advanced non-small lung cancer | |
Title of the study (Brief title) | Proton beam therapy dose escalation for NSCLC | |
Region |
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Condition | |||
Condition | Unresectable Non-small Lung Cancer | ||
Classification by specialty |
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Classification by malignancy | Malignancy | ||
Genomic information | NO |
Objectives | |
Narrative objectives1 | To define the recommended dose of proton beam therapy concurrent with chemotherapy for unresectable non-small lung cancer |
Basic objectives2 | Safety |
Basic objectives -Others | |
Trial characteristics_1 | Confirmatory |
Trial characteristics_2 | Pragmatic |
Developmental phase | Phase I |
Assessment | |
Primary outcomes | To determine maximum torrelated dose and recommended dose |
Key secondary outcomes | Adverse event
Tumor response survival rate |
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 | Proton beam therapy 66-74 GyE
(Cisplatin 60mg/m2 + TS-1 40mg d1-d4) |
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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 | Histologically proven Non-small lung cancer, Stage IIIA-IIIB
ECOG PS 0-1 Tumor size was measured by 4 wks before registration Good organ function |
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Key exclusion criteria | Drug allergy
Active infection Lymph node metastasis at contra-lateral hiller, supraclavicular region. P Severe complication Apparent interstitial pneumonitis |
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Target sample size | 12 |
Research contact person | |
Name of lead principal investigator | Hiroshi Fuji |
Organization | Shizuoka Cancer Center |
Division name | Division of Proton therapy |
Address | 1007 Shimonagakubo, Nagaizumi-cho, Shizuoka-pref. |
TEL | 055-989-5222 |
Public contact | |
Name of contact person | Hiroshi Fuji |
Organization | Shizuoka Cancer Center |
Division name | Division of Proton therapy |
Address | 1007 Shimonagakubo, Nagaizumi-cho, Shizuoka-pref. |
TEL | 055-989-5222 |
Homepage URL | |
h.fuji@scchr.jp |
Sponsor | |
Institute | Shizuoka Cancer Center |
Institute | |
Department |
Funding Source | |
Organization | none |
Organization | |
Division | |
Category of Funding Organization | Other |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
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 | 静岡県立静岡がんセンター(静岡県) |
Other administrative information | |||||||
Date of disclosure of the study information |
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Progress | |||||||
Recruitment status | Completed | ||||||
Date of protocol fixation |
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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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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
URL releasing results | |
Results | |
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=R000006512 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |