Phase I study of concurrent chemoradiotherapy with docetaxel,cisplatin and 5-fluorouracil (DCF) in patients with locally advanced cancer of the external auditory canal and middle ear.

Phase I study of concurrent chemoradiotherapy with docetaxel,cisplatin and 5-fluorouracil (DCF) in patients with locally advanced cancer of the external auditory canal and middle ear. - Phase I study of CCRT with DCF for advanced ear cancer

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000013304

Enrollment

Registered

2014-03-01

Start date

2014-03-01

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

Neoplasm of the external auditory canal and middle ear

Interventions

Concurrent chemoradiotherapy docetaxel 40-60 mg/m2/day day1 iv cisplatin 70 mg/m2/day day1 iv 5-fluorouracil 700 mg/m2/day day1-5 civ q4w , 2 cycle RT 66Gy/33fr/7w Radiotherapy starts on da

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically proven squamous cell carcinoma of the external auditory canal or middle ear 2) Primary lesion is located in the external auditory canal or middle ear 3) With T3 and T4 tumors in Pittsburgh tumor staging system (modified in 2000) 4) Patients with T3 tumors rejecting operation 5) No previous treatment of ear cancer without excisional biopsy or unresectable reccurrent tumor 6) No distant organ metastases 7) Aged 20 to 75 years old 8) ECOG PS of 0 or 1 9) No previous radiotherapy in head and neck lesion or radiologist permits curative additional radiotherapy 10) No previous chemotherapy within three years 11) Adequate organ functions 12) Written informed consent

Exclusion criteria

Exclusion criteria: 1) Pregnant or lactating women or women of childbearing potential 2) Psychosis 3) Patients requiring systemic steroids medication 4) HBs antigen positive 5) HCV antibody positive 6) HIV antibody positive 7) Uncontrollable diabetes millutus 8) History of myocardial infarction within three months 9) History of unstable angina pectoris or interstitial pneumonia or fibroid lung or severe emphysema 10) Active bacterial or fungous infection 11) In case of judge as inadequate subjects by attending physician

Design outcomes

Primary

Measure	Time frame
Maximum tolerated dose and recommended dose	—

Secondary

Measure	Time frame
frequency and severity of side effects	—

Countries

Japan

Contacts

Public ContactShingo Hasegawa, M.D, PhD

Kobe University Hospital Otolaryngology-Head & Neck Surgery

shingo@med.kobe-u.ac.jp0783825111

Outcome results

None listed

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