Unique ID issued by UMIN | UMIN000021137 |
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Receipt number | R000024359 |
Scientific Title | Alleviating Effect of Lafutidine on Toxicity of S-1: Adjuvant Chemotherapy with S-1 after curative treatment in patients with squamous cell carcinoma of the head and neck |
Date of disclosure of the study information | 2016/02/22 |
Last modified on | 2020/02/25 13:17:31 |
Alleviating Effect of Lafutidine on Toxicity of S-1: Adjuvant Chemotherapy with S-1 after curative treatment in patients with squamous cell carcinoma of the head and neck
Alleviating Effect of Lafutidine on Toxicity of S-1: Adjuvant Chemotherapy with S-1 after curative treatment in patients with squamous cell carcinoma of the head and neck
Alleviating Effect of Lafutidine on Toxicity of S-1: Adjuvant Chemotherapy with S-1 after curative treatment in patients with squamous cell carcinoma of the head and neck
Alleviating Effect of Lafutidine on Toxicity of S-1: Adjuvant Chemotherapy with S-1 after curative treatment in patients with squamous cell carcinoma of the head and neck
Japan |
Head and Neck squamous cell carcinoma
Oto-rhino-laryngology |
Malignancy
NO
Evaluation of alleviating Effect of Lafutidine on Toxicity of S-1
Safety,Efficacy
Exploratory
Explanatory
Completion rate of S-1 treatment according to planned
1) safety
2) Medication compliance
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
S-1: 40, 50, 60mg/m2 PO bid (morning and evening) for 2 weeks with 1 weeks rest Lafutidine: 10mg/body PO bid (morning and evening) everyday
In total of 1 year after curative treatment
20 | years-old | <= |
75 | years-old | >= |
Male and Female
1) Histological proven squamous cell carcinoma of the head and neck
2) Primary site, maxillary sinus, oral cavity, oropharynx, hypopharynx or larynx
3) Initial definitive treatment (surgery treatment and radiation therapy) is carried out clinical or pathological stage Stage3 or Stage4A, 4B cases.
4) Initial curative treatment after the end of three months the tumor within patients (primary tumor and lymph node metastases) disappearance has been confirmed
5)Not chemotherapy in the period leading up to registration from after the initial curative treatment end
6) Age 20-75 years
7) Performance status (PS) 0-1
8) Patient can start administration of S-1 within 3 months after Initial definitive treatment.
9) Adequate organ functions defined as indicated below
(1)WBC >= 3,500 /mm3 , WBC <= 12,000 /mm3
(2)neutrophil >= 1,500 /mm3
(3)Plt >= 100,000 /mm3
(4) Hb>= 9.0 g/ dL
(5) T.Bil <= 1.5 mg/dL
(6) AST(GOT) , ALT(GPT) <= 100 IU/L
(7) Cr < 1.2 mg/dL
10) Written informed consent
1) Patient with active double cancer (synchronous double cancer and metachronous double cancer)
2) Patient with administration contraindication of S-1 and Lafutidine
20
1st name | |
Middle name | |
Last name | Kiyoaki Tsukahara, MD |
Tokyo medical university
otolaryngology
6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo
03-3342-6111
tsuka@tokyo-med.ac.jp
1st name | |
Middle name | |
Last name | Isaku Okamoto, MD |
Tokyo medical university
otolaryngology
6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo
03-3342-6111
isaku@tokyo-med.ac.jp
Tokyo medical university
Tokyo medical university
Other
NO
2016 | Year | 02 | Month | 22 | Day |
Unpublished
Terminated
2015 | Year | 11 | Month | 01 | Day |
2015 | Year | 12 | Month | 08 | Day |
2016 | Year | 03 | Month | 02 | Day |
2018 | Year | 12 | Month | 31 | Day |
2016 | Year | 02 | Month | 22 | Day |
2020 | Year | 02 | Month | 25 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024359
Research Plan | |
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Registered date | File name |
2018/02/23 | ③実施計画書.docx |
Research case data specifications | |
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Registered date | File name |
2018/02/23 | 術後研究_症例登録表.docx |
Research case data | |
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Registered date | File name |
2018/02/23 | 症例データ⑭.pdf |