Unique ID issued by UMIN | UMIN000009856 |
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Receipt number | R000011547 |
Scientific Title | To adjuvant chemotherapy after curative treatment of head and neck cancer A study of alternate-day administration definitive TS-1 |
Date of disclosure of the study information | 2013/01/24 |
Last modified on | 2013/01/24 10:43:21 |
To adjuvant chemotherapy after curative treatment of head and neck cancer A study of alternate-day administration definitive TS-1
Phase II of the TS-1 every other day dosing regimen in head and neck cancer
To adjuvant chemotherapy after curative treatment of head and neck cancer A study of alternate-day administration definitive TS-1
Phase II of the TS-1 every other day dosing regimen in head and neck cancer
Japan |
Head and neck cancer
Oto-rhino-laryngology |
Malignancy
NO
Consider the accomplishment rate of administration as adjuvant chemotherapy after curative treatment of head and neck cancer, in the alternate-day administration of the granule formulation TS-1.
Safety,Efficacy
Pragmatic
Completion percentage administration
Adverse event, Total dose for dose planning ,survival, recurrence-free survival
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine |
TS-1 performed in alternate-day dosing
20 | years-old | <= |
Not applicable |
Male and Female
Intended for cases corresponding to all of the following items.
1)Cases would be diagnosed with squamous cell carcinoma (except thyroid) primary tumor by histological or cytological diagnosis, curative treatment was performed.In addition, diagnostic imaging(chest X-ray, ultrasound, CT, MRI, such as PET) after two months followed by radiotherapy treatment and surgery (including combination therapy chemoradiation therapy) curative Tumor Free will be confirmed by it is defined as Ru.
2)Maxillary sinus, oral cavity, oropharynx , primary site, larynx (T3N0 glottic excluded) case is it or hypopharynx
3)Cases of IV A , IV B Stage III Stage or clinical or pathological stage
4)Case you do not have anti-cancer treatment until after the end of curative treatment initial registration
5)Patient age at the time of obtaining informed consent is 20 years of age or older
6)0-1 is a case: (PS Performance status) general condition
7)capable of oral intake
8)Patients with the following conditions are met in the bone marrow within 14 days prior to enrollment, liver and renal function
i)WBC:>=3,500/mm3,<12,000/mm3
ii)neutrophil:>=1,500/mm3
iii)blood platelet:>=100,000mm3
iv)hemoglobin:>=9.0g/dL
v)total bilirubin:=2.0mg/dL
vi)AST(GOT):<=100IU/L
ALT(GPT):<=100IU/L
vii)Creatinine clearance:>= case is greater than or equal to 60ml/min
1)It is contraindicated in patients with the administration of TS-1
2)Cases that are complicated by infection requiring treatment
3)Gastrointestinal disease with treatment (intestinal paralysis, intestinal obstruction, etc.) Patients with
4)Patients with interstitial pneumonitis or pulmonary fibrosis
5)Patients with diabetes
6)Patients with heart disease
7)Patients with (watery) diarrhea
8)Patients attending physician was deemed inappropriate as the subject of the study for other reasons
55
1st name | |
Middle name | |
Last name | Nirou Tayama |
National Center for Global health and Medicine
Otolarygology
1-21-1 Toyama, Shinjuku-ku, Tokyo, 162-8655, Japan
03-3202-7181
1st name | |
Middle name | |
Last name | Takahiro Asakage |
Hospital School of Medicine,University of Tokyo
Otolarygology,Auditory speech surgery
7-3-1 Hongoh,Bunkyou-ku,Tokyo,Japan
03-5800-8665
National Center for Global health and Medicine
Otolarygology
National Center for Global health and Medicine
Otolarygology
Self funding
NO
2013 | Year | 01 | Month | 24 | Day |
Unpublished
No longer recruiting
2012 | Year | 08 | Month | 31 | Day |
2013 | Year | 02 | Month | 01 | Day |
2015 | Year | 09 | Month | 01 | Day |
2013 | Year | 01 | Month | 24 | Day |
2013 | Year | 01 | Month | 24 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011547
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