Unique ID issued by UMIN | UMIN000005628 |
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Receipt number | R000006652 |
Scientific Title | Pharmacogenomic study of TPF regimen (combination chemotherapy of docetaxel, cisplatin, and 5-fluorouracil) in hypopharyngeal cancer |
Date of disclosure of the study information | 2011/05/25 |
Last modified on | 2019/05/30 15:55:05 |
Pharmacogenomic study of TPF regimen (combination chemotherapy of docetaxel, cisplatin, and 5-fluorouracil) in hypopharyngeal cancer
Pharmacogenomic study of TPF regimen in hypopharyngeal cancer
Pharmacogenomic study of TPF regimen (combination chemotherapy of docetaxel, cisplatin, and 5-fluorouracil) in hypopharyngeal cancer
Pharmacogenomic study of TPF regimen in hypopharyngeal cancer
Japan |
Hypopharyngeal cancer
Oto-rhino-laryngology |
Malignancy
YES
To assess the efficacy and safety of combination chemotherapy for stage III, and IV locally advanced hypopharyngeal squamous cell carcinoma. Predictive factors for these outcomes will be assessed by pharmacogenomics analysis.
Efficacy
Response rate (RECIST)
markers.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Iv, administration of TXT (75mg/m2) and CDDP(75mg/m2) on day1. Continuous iv infusion of 5-FU (750mg/m2/day) from day 1 to day 5. 1cycle. 28 days. Equal to or more than 2 cycle (max 4cycles).
20 | years-old | <= |
Not applicable |
Male and Female
Histologically confirmed squamous cell carcinoma of hypopharynx.
2) Stage III, and IV case.
3) The patient must have measurable disease (RECIST)
4) Any therapy should not have been given for the current disease.
5) Age 20 years or older
6) ECOG Performance Status 0-2
7) Patient must have appropriate organ function (bone marrow, liver, kidney, cardiac, etc.) and the laboratory value within 7 days before the protocol treatment must be
WBC 4,000/mm3 or more
ANC 2,000/mm3 or more
Platelet 100,000/mm3 or more
Hemoglobin 9.0g/dl or more
AST, ALT x2 institutional ULN or less
Serum Total Bilirubin 1.5 mg/dL or less
Serum Creatinine 1.5 mg/dL or less
Creatinine clearance 60 ml/min or more
BUN 25mg/dl or less
ECG Normal
8) Collected tissue sample with biopsy enough for genomic analysis.
9) Life expectancy must be 12 weeks or more.
10) Written informed consent must be obtained for the study including blood or tissue sampling.
Patients who did not meet the above mentioned inclusion criteria.
2) No distant metastases were existed when treatment was started.
3) Patients with severe hypersensitivities or drug allergy.
4) Patients with history of hypersensitivity reactions to polysorbate 80.
5) Patients with considerable cancerous body cavity fluid.
6) Patients with obvious infectious disease
7) Patients with watery diarrhea.
8) Patients with intestinal paralysis or obstruction.
9) Patients with severe aspiration, and high risk for aspiration pneumonia.
10) Patients with severe complications. (Examples: pulmonary fibrosis, interstitial pneumonia, tendency to bleed, active bleeding with necessity for frequent transfusion.)
11) Patients with peripheral (sensory or motor) neuropathy Grade 2 or greater.
12) Patients with edema Grade 2 or greater.
13) Patients with continuous administration of phenytoin, and warfarin potassium.
14) Patients with liver cirrhosis.
15) Patients with active double cancer.
16) Patients with uncontrollable diabetes
17) Patients with clinically serious cardiac disease.
18) Patients with clnically serious psycho-neurological disease for continuation therapy.
19) Patients who are pregnant or breast feeding or possibility of pregnancy
20) Patients whom investigators determined it impossible to complete the protocol treatment safely.
80
1st name | Masashi |
Middle name | |
Last name | Sugasawa |
Saitama Medical University, International Medical Center
Department of Head and Neck Surgery
350-1298
1397-1 Yamane, Hidaka City, Saitama, Japan
042-984-4629
msuga@saitama-med.ac.jp
1st name | Masashi |
Middle name | |
Last name | Sugasawa |
Saitama Medical University, International Medical Center
Department of Head and Neck Surgery
350-1298
1397-1 Yamane, Hidaka City, Saitama, Japan.
042-984-4629
msuga@saitama-med.ac.jp
Department of Head and Neck Surgery, Saitama Medical University International Medical Center
Department of Head and Neck Surgery, International Medical Center, Saitama medical university.
Self funding
Saitama Medical university IRB committee
38 Morohongo Moyoyama Saitama Japan
049-276-2143
rinri@saitama-med.ac.jp
NO
埼玉医科大学国際医療センター(埼玉県)
2011 | Year | 05 | Month | 25 | Day |
Unpublished
14
Terminated
2011 | Year | 04 | Month | 25 | Day |
2011 | Year | 04 | Month | 25 | Day |
2011 | Year | 06 | Month | 01 | Day |
2018 | Year | 12 | Month | 31 | Day |
2011 | Year | 05 | Month | 23 | Day |
2019 | Year | 05 | Month | 30 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006652
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