Feasibility study of concurrent chemoradiotherapy with docetaxel and cisplatin for head and neck cancer in the elderly or mild renal dysfunction -Multicenter study-

Feasibility study of concurrent chemoradiotherapy with docetaxel and cisplatin for head and neck cancer in the elderly or mild renal dysfunction -Multicenter study- - Feasibility study of concurrent chemoradiotherapy with docetaxel and cisplatin for head and neck cancer in the elderly or mild renal dysfunction -Multicenter study-

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000009270

Enrollment

Registered

2012-11-11

Start date

2012-11-11

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

head and neck cancer

Interventions

Concurrent chemoradiotherapy Radiotherapy: 2Gy/fraction/day, 5fractions/week, total dose of 66Gy/33fractions/7weeks Chemotherapy: weekly administration of cisplatin 20mg/m2 and docetaxel 10mg/m2,

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) no tumor-specific pretreatment 2) no prior radiation against the same field as currently scheduled 3) estimable or measurable lesion 4) Eastern Cooperative Oncology Group (ECOG) performance status 0-2 5) expected survival duration for > 3months after the biginning of the treatment 6) no major impairment of liver, kidney, or bone marrow, fulfilling the condition of AST/ALT <2times the upper limit of normal, BUN <25mg/dl, serum creatinine <1.5mg/dl, creatinine clearance >=40ml/min(age 76-80 yeas old), 60ml/min >creatinine clearance >=40ml/min(age 20-75 yeas old), white blood cell count >4000/mm3, neutrophil count >2000/mm3, and platelet count >100,000/mm3 7) no evidence of active infection or fever >38C 8) written informed consent

Exclusion criteria

Exclusion criteria: 1) interstitial pneumonia or pulmonary fibrosis evidenced by chest X-ray and/or chest CT 2) major heart/lung disorders, or uncontrolled diabetes mellitus 3) distant metastases or second primary cancer except when there has been no evidence of the disease for more than 24 months without any treatment 4) major pulmonary effusion or ascites 5) neuropathy or edema 6) pregnancy or lactation 7) history of major allergy to medicine 8) long use of steroid

Design outcomes

Primary

Measure	Time frame
Completion rate, safety	—

Secondary

Measure	Time frame
Adverse event rate treatment response rate 2-year overall survival rate 2-year disease specific survival rate 2-year disease free survival rate	—

Countries

Japan

Contacts

Public ContactNorihiko Takemoto

Osaka University School of Medicine Department of Otolaryngology-Head and Neck Surgery

ntakemoto@ent.med.osaka-u.ac.jp06-6879-3951

Outcome results

None listed

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