Know Cancer

forgot password

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

Phase 2
18 Years
Not Enrolling
Head and Neck Cancer

Thank you

Trial Information

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

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.

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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate

Outcome Description:

After completion of CCRT, response rate was assessed. Patients underwent examination by an otolaryngologist, CT or MRI imaging of the primary tumor and neck. A biopsy of the primary site was recommended if possible. Tumor response was assessed according to the RECIST. For all patients with complete response (CR) on physical examination and CT or MRI scan, PET scan was performed for confirmation at 1 month after CT or MRI confirmation.

Outcome Time Frame:

Response rate was evaluated 1 months after completion of CCRT

Safety Issue:


Principal Investigator

Sang-Hee Cho, M.D.Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:



Korea: Institutional Review Board

Study ID:




Start Date:

October 2008

Completion Date:

March 2012

Related Keywords:

  • Head and Neck Cancer
  • head and neck cancer
  • docetaxel
  • cisplatin
  • S-1
  • Neoplasms, Squamous Cell
  • Head and Neck Neoplasms