Unique ID issued by UMIN | UMIN000012139 |
---|---|
Receipt number | R000014195 |
Scientific Title | Muti instuitutional clinical study of transoral robotic surgery for laryngopharyngeal cancer - a pilot study - |
Date of disclosure of the study information | 2013/10/28 |
Last modified on | 2016/02/05 01:00:18 |
Muti instuitutional clinical study of transoral robotic surgery for laryngopharyngeal cancer - a pilot study -
Transoral robotic sugery for laryngopharyngeal cancer - a pilot study -
Muti instuitutional clinical study of transoral robotic surgery for laryngopharyngeal cancer - a pilot study -
Transoral robotic sugery for laryngopharyngeal cancer - a pilot study -
Japan |
Laryngopharyngeal cancer
Oto-rhino-laryngology |
Malignancy
NO
To evaluate the safety and efficacy of transoral robotic surgery for laryngopharyngeal cancer
Safety,Efficacy
Confirmatory
Pragmatic
Phase I
Positive surgical martin rate
Completion rate of surgery, hospitalzation period, NG tube or PEG dependency rate
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Device,equipment | Maneuver |
Transoral robotic surgery
20 | years-old | <= |
85 | years-old | > |
Male and Female
1) Single cancer lesion in mesopharynx, hypopharynx, or larynx
2) Diagnosed as squamous cell carcinoma
3) Fultill the following conditions: regarding TNM
a)Tis, T1, or T2 cancer
b)N0 or non extracapsule invation N(+) after neck dissection more than 10 days prior to registration
c)M0
4) Primary lesion has no adhesion with neiboring tissue and is movable
5) ECOG PS is 0, 1, or 2
6) Fulfill the following condition within 4 weeks prior to registration date
Hb more than 8 g/dL
Plt more than 50000/uL
AST less than 120 IU/L
ALT less than 120 IU/L
Cre less than 1.5mg/dL
7) Obtained consent form from the candidate
1) No tristmus
2) Having the following condition of diseases:
#Synchronistic advanced cancer which needs systemic treatment
#History of radiation therapy for the primary site
3) Metachronistric invasive cancer of laryngopharynx in the same sublesion of the same side.
4) Having the following diseases:
Severe cardiovascular and/or respiratory disease
Uncontroled DM
5) Pregnant women and possible pregnant women
6) Patients whom attending doctor consider to be inappropriate to attend the study
7
1st name | |
Middle name | |
Last name | Ichiro Tateya |
Kyoto University
Otolaryngology-Head & Neck Surgery
Sakyo-ku Kyoto 606-8507 Japan
075-751-3346
tateya@ent.kuhp.kyoto-u.ac.jp
1st name | |
Middle name | |
Last name | Toshinori Murayama |
Kyoto University
Instititute for Advancement of Clinical and Translational Science
Sakyo-ku, Kyoto, 606-8507 Japan
075-751-4739
murayama@kuhp.kyoto-u.ac.jp
Kyoto University
MHLW
Japan
Tottori University
Tokyo Medical University
NO
京都大学医学部附属病院
東京医科大学附属病院
鳥取大学医学部附属病院
2013 | Year | 10 | Month | 28 | Day |
Unpublished
No longer recruiting
2013 | Year | 12 | Month | 01 | Day |
2013 | Year | 12 | Month | 01 | Day |
2015 | Year | 03 | Month | 31 | Day |
2015 | Year | 03 | Month | 31 | Day |
2015 | Year | 03 | Month | 31 | Day |
2016 | Year | 03 | Month | 31 | Day |
2013 | Year | 10 | Month | 28 | Day |
2016 | Year | 02 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014195
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |