Unique ID issued by UMIN | UMIN000010369 |
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Receipt number | R000012134 |
Scientific Title | Phase I/II study on completion rate of concurrent chemoradiotherapy which regimen is assumed by only CDDP for head and neck squamous cell carcinoma |
Date of disclosure of the study information | 2013/04/01 |
Last modified on | 2018/04/24 10:13:01 |
Phase I/II study on completion rate of concurrent chemoradiotherapy which regimen is assumed by only CDDP for head and neck squamous cell carcinoma
Concurrent chemoradiotherapy which regimen is assumed by only CDDP
Phase I/II study on completion rate of concurrent chemoradiotherapy which regimen is assumed by only CDDP for head and neck squamous cell carcinoma
Concurrent chemoradiotherapy which regimen is assumed by only CDDP
Japan |
Head and neck cancer
Oto-rhino-laryngology |
Malignancy
NO
We decide maximum tolerated dose (MTD) and dose limiting toxicity (DLT) in concurrent chemoradiotherapy (CCRT) which regimen is assumed by only CDDP for head and neck cancer, and examine the effect and safety. The main end-point is MTD and DLT in phase I, and rate of CCRT completion in phase II.
Safety,Efficacy
Confirmatory
Pragmatic
Phase I,II
Decision of MTD and DLT (phase I)
Rate of CCRT completion (phase II)
The adverse effect, rate of CCRT completion (Phase I)
Renal dysfunction more than grade 2, response rate, inflammation of mucosa more than grade 3, rate of chemotherapy completion (Phase II)
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
3 courses of CDDP every 3 weeks during radiation therapy
20 | years-old | <= |
75 | years-old | > |
Male and Female
1)Pathologic or cytologic diagnosis of head and neck squamous cell carcinoma treated with radical CCRT, ie, whole-neck irradiation including bilateral levels II-IV
2)Initial chemotherapy
3)Measurable or evaluable lesions
4)Performance status(PS) 0-1
5)Age 20-75 years
6)No complication that might affect treatment
7)No other cancer
8)Normal liver, kidney, and marrow function
White blood cells >3,000/ mm3
Neutrophilic >1,500/mm3
Blood platelet >100,000/mm3
Total bilirubin normal
AST and ALT normal
Creatinine normal
Ccr or eGFR >60ml/min
9)Written informed consent
1)Past history of serious drug hypersensitivity
2)Presence of other cancer
3)Clinically problematic infectious disease
4)>1 complication that might affect treatment
5) Nonradical treatment indicated
6)Pregnant or nursing women and those with the possibility of pregnancy
7)Mental or neurologic disease that might affect participation
8)Participation judged by physician to be inadvisable
50
1st name | |
Middle name | |
Last name | Hiroshi Matsuyama |
Niigata University, Faculty of Medicine
Otolaryngology, Head and Neck
1-757 Asahimachi-dori, Chuo-ku, Niigata-shi, Niigata-ken
+81-25-227-2306
matsuhiroshi@med.niigata-u.ac.jp
1st name | |
Middle name | |
Last name | Hiroshi Matsuyama |
Niigata University, Faculty of Medicine
Otolaryngology, Head and Neck
1-757 Asahimachi-dori, Chuo-ku, Niigata-shi, Niigata-ken
+81-25-227-2306
matsuhiroshi@med.niigata-u.ac.jp
Niigata University, Faculty of Medicine
None
Self funding
Niigata Cancer Center Hospital
Niigata City General Hospital
Nagaoka Red Cross Hospital
NO
新潟大学医歯学総合病院(新潟県)
新潟県立がんセンター新潟病院(新潟県)
新潟市民病院(新潟県)
長岡赤十字病院(新潟県)
2013 | Year | 04 | Month | 01 | Day |
Published
Phase II study was finished
Now stand-by for published of main results
Completed
2013 | Year | 04 | Month | 01 | Day |
2013 | Year | 11 | Month | 01 | Day |
2017 | Year | 03 | Month | 31 | Day |
2017 | Year | 08 | Month | 20 | Day |
2017 | Year | 08 | Month | 20 | Day |
2017 | Year | 08 | Month | 20 | Day |
2013 | Year | 03 | Month | 31 | Day |
2018 | Year | 04 | Month | 24 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012134
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