Induction chemotherapy with docetaxel, cisplatin and 5-fluorouracil followed by chemoradiotherapy concurrent with fractionated administration of high-dose cisplatin for patients with locally advanced squamous cell carcinoma of the head and neck

Induction chemotherapy with docetaxel, cisplatin and 5-fluorouracil followed by chemoradiotherapy concurrent with fractionated administration of high-dose cisplatin for patients with locally advanced squamous cell carcinoma of the head and neck - TPF study for Japanese

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000024686

Enrollment

Registered

2016-11-02

Start date

2010-07-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Locally advanced head and neck cancer

Interventions

Induction chemotherapy(TPF) Docetaxel: 70-75mg/m2, day1 Cisplatin: 70-75mg/m2, day1 Fluorouracil: 750mg/m2, day1-5 q3w, total 3cycles Chemoradiotherapy(CRT) Cisplatin: 20mg/m2, day1-4 q

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Histologically confirmed Squamous cell carcinoma Following primary sites: Larynx, Oropharynx and Hypopharynx Unresectable locally advanced head and neck cancer No metastasis Age from 20 to 75 PS(ECOG): 0 or 1 No prior treatment of definitive operation No prior treatment with systemic anti-cancer therapy, radiotherapy or hormone therapy Adequate organ function Signed informed consent

Exclusion criteria

Exclusion criteria: Active bacterial or fungus infection Active Malignant disease, other than that being treated in this study Pregnant or lactating women Clinically significant and/or uncontrolled heart disease History of cerebrovascular disease Uncontrolled diabetes or hypertension Severe complications

Design outcomes

Primary

Measure	Time frame
Feasibility of TPF	—

Secondary

Measure	Time frame
overall response rate to TPF local recurrence-free survival progression-free survival overall survival safety profile	—

Countries

Japan

Contacts

Public ContactSusumu Okano

National Cancer Center Hospital East Head and Neck Medical Oncology

sokano@east.ncc.go.jp04-7133-1111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026