Clinical trial NCT01645748: Docetaxel, Cisplatin, and S-1 (TPS) Induction Chemotherapy in Locally Advanced Head and Neck Cancer
Official title: Multicenter Phase II Study of Weekly Docetaxel, Cisplatin, and S-1 (TPS) Induction Chemotherapy in Locally Advanced Squamous Cell Cancer of the Head and Neck
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Head and Neck Cancer
Keywords: head and neck cancer
docetaxel
cisplatin
S-1
Lead sponsor: Chonnam National University Hospital
Sponsor class: OTHER
Collaborators: name: Chungbuk National University
name: Chonbuk National University
name: Chungnam National University
First posted: 2012-07-20
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to evaluate the tolerability and efficacy of a combination of weekly docetaxel, cisplatin, and S-1 (weekly TPS) as induction chemotherapy in patients with locally advanced head and neck squamous cell carcinoma (HNSCC).

Detailed description: Combination chemotherapy with cisplatin and fluorouracil (CF) is the standard treatment for patients with locally advanced squamous cancer of the head and neck. CF chemotherapy has been reported to increase survival and disease free survival in patients with unresectable disease when given before definitive radiotherapy, showing overall response rate as 75-85% including of CR rate of 25-35%. To improvement of treatment, docetaxel was incorporated into CF as induction treatment and it showed the prolongation of progression free survival and overall survival in large scale of randomized phase III trials, therefore triple combination induction regimen would be standard treatment in advanced head and neck cancer. Recently, the introduction of oral fluoropyrimidine showed similar or enhanced response rate, also favorable safety and convenience than intravenous fluoropyrimidine in advanced gastric cancer. Of the oral fluoropyrimidines, S-1 showed promising preliminary result in combination chemotherapy with cisplatin in head and neck cancer. 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, 60mg/m2 (D1) and 60mg/m2 (D1), respectively. Therefore, the aim of this study was to evaluate the efficacy and safety of docetaxel, cisplatin and S-1 combination chemotherapy according to above dosage.

Eligibility criteria: Inclusion Criteria:

* locally advanced stage III or IV squamous cell carcinoma of the larynx, oropharynx, or hypopharynx
* ≥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:

* received previous chemotherapy
* 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

Primary outcomes:
measure: Response rate
timeFrame: Response rate was evaluated 1 months after completion of CCRT
Secondary outcomes:
measure: Safety
timeFrame: From initiation of induction chemotherapy up to 18 weeks
measure: Progression free survival
timeFrame: From initiation of treatment up to 2 years
measure: Overall survival
timeFrame: From initiatin of treatment up to 2 years
Other outcomes:
Locations:
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
state: Jeollanamdo
Study officials:
affiliation: CNUHH
name: Sang-Hee Cho, M.D.Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.