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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000036646 |
Receipt No. | R000041746 |
Scientific Title | Phase II trial of transoral robotic surgery for laryngo-pharyngeal cancer |
Date of disclosure of the study information | 2019/08/01 |
Last modified on | 2019/05/03 |
Basic information | ||
Public title | Evaluation of safety and efficacy of transoral robotic surgery for laryngo-pharyngeal cancer | |
Acronym | Evaluation of safety and efficacy of transoral robotic surgery for laryngo-pharyngeal cancer | |
Scientific Title | Phase II trial of transoral robotic surgery for laryngo-pharyngeal cancer | |
Scientific Title:Acronym | Phase II trial of transoral robotic surgery for laryngo-pharyngeal cancer | |
Region |
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Condition | ||
Condition | Laryngo-pharyngeal cancer | |
Classification by specialty |
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Classification by malignancy | Malignancy | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To evaluate safety and efficacy of transoral robotic surgery for laryngo-pharyngeal cancer |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Positive rate of surgical margin |
Key secondary outcomes | Postoperative swallowing function |
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 | Transoral robotic surgery | |
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) Oropharyngeal, Hypopharyngeal or supraglottic cancer confirmed by pathological diagnosis
(2) Tis-T2 or superficial T3 diagnosed by endoscopy or imaging test (CT, MRI or PET/CT) (3) Tumor invasion within pharyngeal constrictor (4) N0-N2b in p16-negative oropharyngeal, hypopharyngeal or supraglottic cancer (5) N0-1 in p16-positive oropharyngeal cancer (6) ECOG-PS 0-1 (7) Blood test results meeting the following requirements 1) Leukocyte count < 2,000/mm3 2) Platelate count < 100,000/mm3 3) AST= or <100 IU/L, ALT= or <100 IU/L 4) Total bilirubin= or <2.0 mg/dL (8) Age= or >20 (9) Providing written informed consent |
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Key exclusion criteria | (1) Poor exposure of surgical field due to trismus or difficulty of neck extension
(2) Extranodal extention of lymph node metastasis (3) bilateral cervical lymph node metastases (4) Distant metastasis (5) Difficulty of discontinuation of anticoagulant or antiplatelet drug (6) Pregnancy (7) Unsuitable for inclusion at the discretion of the researchers |
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Target sample size | 30 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Kitasato University | ||||||
Division name | School of Medicine | ||||||
Zip code | 252-0374 | ||||||
Address | 1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa | ||||||
TEL | 042-778-8111 | ||||||
tyamahns@kitasato-u.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Kitasato University | ||||||
Division name | School of Medicine | ||||||
Zip code | 252-0374 | ||||||
Address | 1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa | ||||||
TEL | 042-778-8111 | ||||||
Homepage URL | |||||||
s-miya@kitasato-u.ac.jp |
Sponsor | |
Institute | Kitasato University, School of Medicine |
Institute | |
Department |
Funding Source | |
Organization | Self funding |
Organization | |
Division | |
Category of Funding Organization | Self funding |
Nationality of Funding Organization | Japan |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | The Kitasato University Medical Ethics Organization |
Address | 1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa |
Tel | 042-778-8111 |
rinrib@med.kitasato-u.ac.jp |
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 | |
Outcome measures | |
Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Preinitiation | ||||||
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=R000041746 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |