Assessment of the efficacy and safety of 5-FU/CDDP/Cetuximab (FPE) induction chemotherapy in patients with locally advanced head and neck squamous cell carcinoma

Assessment of the efficacy and safety of 5-FU/CDDP/Cetuximab (FPE) induction chemotherapy in patients with locally advanced head and neck squamous cell carcinoma - Assessment of the efficacy and safety of FPE induction chemotherapy in patients with LASCCHN

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000031146

Enrollment

Registered

2018-02-05

Start date

2018-02-05

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 squamous cell carcinoma

Interventions

5-FU 800mg/sqr day1-4 CDDP 80mg/sqr day1 Cetuximab 250mg/sqr(initial dose only:400mg/sqr)day1, 8, 15 every 21 days

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: patients with locally advanced head and neck squamous cell carcinoma(primary cite: larynx, oropharynx and hypopharynx. /N classification: N2, N2b, N2c and N3)

Exclusion criteria

Exclusion criteria: Performance status 2 and more

Design outcomes

Primary

Measure	Time frame
response rate of consecutive 3 courses	—

Secondary

Measure	Time frame
safety(CTCAE), progression free survival, compliance(dose intensity)	—

Countries

Japan

Contacts

Public ContactMoriyasu Yamauchi

Saga University Department of Otolaryngology - Head & Neck Surgery

yamamori@cc.saga-u.ac.jp0952-34-2379

Outcome results

None listed

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