Docetaxel, Cisplatin, and S-1 (TPS) Induction Chemotherapy in Locally Advanced Head and Neck Cancer
NCT ID: NCT01645748
Last Updated: 2012-07-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
35 participants
INTERVENTIONAL
2008-10-31
2012-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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S-1, induction chemotherapy
Cisplatin and 5-FU is the standard treatment for patients with head and neck cancer. Recently,docetaxel was used into CF, and it showed the prolongation of survival. Oral 5-FU showed similar or enhanced response rate, safety than intravenous 5-FU. S-1 showed promising preliminary result in combination with cisplatin in head and neck cancer. In patients with gastric cancer, phase I study of S-1, docetaxel and cisplatin combination chemotherapy was reported and the recommended doses were 40mg/m2 bid, 60mg/m2 (D1) and 60mg/m2 (D1), respectively. And weekly docetaxel can reduce adverse events compared to 3 week regimen. The aim of this study was to evaluate the efficacy and safety of weekly docetaxel, cisplatin and S-1 combination chemotherapy
S-1
S-1 is an oral fluoropyrimidine derivative, based on the concept of biochemical modulation. It consists in a molar ratio of 1:0.4:1: tegafur, a prodrug that is slowly metabolized to 5-fluorouracil; gimeracil, which reversibly inhibits dihydropyrimidine dehydrogenase. In patients with advanced gastric cancer, phase I study of S-1, docetaxel and cisplatin combination chemotherapy was reported and the recommended doses were 40mg/m2 bid (D1-D14), 60mg/m2 (D1) and 60mg/m2 (D1), respectively.
S-1
Chemotherapy was comprised of docetaxel 30 mg/m2 on days 1 and 8, cisplatin 60 mg/m2 on day 1, and S-1 70 mg/m2 on days 1 to 14, with the regimen repeated every 21 days
S-1
In patients with advanced gastric cancer, phase I study of S-1, docetaxel and cisplatin combination chemotherapy was reported and the recommended doses were 40mg/m2 bid (D1-D14), 60mg/m2 (D1) and 60mg/m2 (D1), respectively. Another phase II study of TPS as induction chemotherapy for locally advanced HNSCC was determined to be 70/70/60 mg∙m2/d every 3 weeks. However, the rate of grade 3-4 neutropenia was 75% at this recommended dose. To reduce the hematologic toxicities, we used the docetaxel weekly. Therefore following regimen was evaluated in this study; docetaxel 30 mg/m2 (D1, D8), cisplatin 60mg/m2 (D1), S-1 70mg/m2 (D1-D14) every 3 weeks.
Interventions
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S-1
S-1 is an oral fluoropyrimidine derivative, based on the concept of biochemical modulation. It consists in a molar ratio of 1:0.4:1: tegafur, a prodrug that is slowly metabolized to 5-fluorouracil; gimeracil, which reversibly inhibits dihydropyrimidine dehydrogenase. In patients with advanced gastric cancer, phase I study of S-1, docetaxel and cisplatin combination chemotherapy was reported and the recommended doses were 40mg/m2 bid (D1-D14), 60mg/m2 (D1) and 60mg/m2 (D1), respectively.
S-1
Chemotherapy was comprised of docetaxel 30 mg/m2 on days 1 and 8, cisplatin 60 mg/m2 on day 1, and S-1 70 mg/m2 on days 1 to 14, with the regimen repeated every 21 days
S-1
In patients with advanced gastric cancer, phase I study of S-1, docetaxel and cisplatin combination chemotherapy was reported and the recommended doses were 40mg/m2 bid (D1-D14), 60mg/m2 (D1) and 60mg/m2 (D1), respectively. Another phase II study of TPS as induction chemotherapy for locally advanced HNSCC was determined to be 70/70/60 mg∙m2/d every 3 weeks. However, the rate of grade 3-4 neutropenia was 75% at this recommended dose. To reduce the hematologic toxicities, we used the docetaxel weekly. Therefore following regimen was evaluated in this study; docetaxel 30 mg/m2 (D1, D8), cisplatin 60mg/m2 (D1), S-1 70mg/m2 (D1-D14) every 3 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ≥18 years old
* absolute neutrophil count ≥1,500/µL, platelets ≥100,000/µL
* serum bilirubin \<2.0 mg/dL
* creatinine \<1.5 mg/dL
* serum transaminase levels less than twice the upper limit of normal
Exclusion Criteria
* another malignancy
* current or history of distant metastasis
* history of clinically significant cardiac disease within 6 months
* active serious infection
* nasopharyngeal carcinoma
* psychiatric illness that would preclude obtaining informed consent
18 Years
ALL
No
Sponsors
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Chungbuk National University
OTHER
Chonbuk National University
OTHER
Chungnam National University
OTHER
Chonnam National University Hospital
OTHER
Responsible Party
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Sang-Hee Cho
Professor
Principal Investigators
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Sang-Hee Cho, M.D.Ph.D.
Role: PRINCIPAL_INVESTIGATOR
CNUHH
Locations
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Chonnam National University Hwasun Hospital
Gwangju, Jeollanamdo, South Korea
Countries
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References
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Bae WK, Hwang JE, Shim HJ, Cho SH, Lee KH, Han HS, Song EK, Yun HJ, Cho IS, Lee JK, Lim SC, Chung WK, Chung IJ. Multicenter phase II study of weekly docetaxel, cisplatin, and S-1 (TPS) induction chemotherapy for locally advanced squamous cell cancer of the head and neck. BMC Cancer. 2013 Mar 6;13:102. doi: 10.1186/1471-2407-13-102.
Other Identifiers
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CNUHH
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
CNUHH-MO-02
Identifier Type: -
Identifier Source: org_study_id