Docetaxel, Cisplatin, and S-1 (TPS) Induction Chemotherapy in Locally Advanced Head and Neck Cancer (TPSHNSCC)

Chonnam National University

Status and phase: Completed; Phase 2

Conditions: Head and Neck Cancer

Treatments: Drug: S-1

Study type: Interventional

Funder types: Other

Identifiers

NCT01645748

CNUHH-MO-02

CNUHH (Other Grant/Funding Number)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

S-1, induction chemotherapy

Experimental group

Description:

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

Treatment:

Drug: S-1

Drug: S-1

Drug: S-1