Unique ID issued by UMIN | UMIN000036646 |
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Receipt number | 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 21:52:30 |
Evaluation of safety and efficacy of transoral robotic surgery for laryngo-pharyngeal cancer
Evaluation of safety and efficacy of transoral robotic surgery for laryngo-pharyngeal cancer
Phase II trial of transoral robotic surgery for laryngo-pharyngeal cancer
Phase II trial of transoral robotic surgery for laryngo-pharyngeal cancer
Japan |
Laryngo-pharyngeal cancer
Oto-rhino-laryngology |
Malignancy
NO
To evaluate safety and efficacy of transoral robotic surgery for laryngo-pharyngeal cancer
Safety,Efficacy
Positive rate of surgical margin
Postoperative swallowing function
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Device,equipment |
Transoral robotic surgery
20 | years-old | <= |
Not applicable |
Male and Female
(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
(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
30
1st name | Taku |
Middle name | |
Last name | Yamashita |
Kitasato University
School of Medicine
252-0374
1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa
042-778-8111
tyamahns@kitasato-u.ac.jp
1st name | Shunsuke |
Middle name | |
Last name | Miyamoto |
Kitasato University
School of Medicine
252-0374
1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa
042-778-8111
s-miya@kitasato-u.ac.jp
Kitasato University, School of Medicine
Self funding
Self funding
Japan
The Kitasato University Medical Ethics Organization
1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa
042-778-8111
rinrib@med.kitasato-u.ac.jp
NO
2019 | Year | 08 | Month | 01 | Day |
Unpublished
Preinitiation
2019 | Year | 05 | Month | 03 | Day |
2019 | Year | 08 | Month | 01 | Day |
2024 | Year | 12 | Month | 31 | Day |
2019 | Year | 05 | Month | 03 | Day |
2019 | Year | 05 | Month | 03 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041746
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