Phase I/II trial of Biweekly induction DCE therapy

Phase I/II trial of induction chemotherapy with bi-weely Docetaxel, Carboplatin, Cetuximab for locally advanced unresectable head and neck cancer.

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs051220137

Enrollment

Registered

2022-12-20

Start date

2023-01-05

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

Head and neck squamous cell carcinoma Head and neck cancer, Squamous cell carcinoma, Induction chemotherapy

Interventions

Combination therapy of docetaxel, carboplatin and cetuximab

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Histologically proven squamous cell carcinoma of head and neck - Primay site of Oral, Oropharynx, Hypopharynx, Larynx. Locally advanced head and neck cancer patient. Age 20 years or older, signed informed consent obtained before any study specific procedures. No previous chemotherapy, No previous radiation therapy for brain, head and neck region. No previous surgery for head and neck cancer ECOG-PS of 0 to 1. Adequate bone marrow, liver function assessed within 14 days before starting study treatment. - Neutrophils counts >= 1500/mm3 - Hb >= 9.0 g/dl - Platelet counts>= 100,000/mm3 - Total bilirubin: =< 1.5 mg/dl (In case of patient with constitutional jaundice, total bilirubin is allowed =< 3.0 mg/dl) - AST/ALT =< 100/100 IU/l - Cr<1.5mg/dl

Exclusion criteria

Exclusion criteria: Active concomitant malignancy except carcinoma in situ or intramucosal tumor within 5 years before study entry. Metastasis Active uncontrolled infection disease needed treatment. HIV infected patient. Lung fibrosis, acute lung damage or intestinal lung disease. Peripheral neuropathy CTCAE Grade 2. Hemodialysis patients. Severe allergy/infusion reaction (Grade 3/4) or side effect for docetaxel, carboplatin or cetuximab. Allergy for beef or Ticks

Design outcomes

Primary

Measure	Time frame
Dose-limiting toxicities(Phase I), Objective Response of bwDCE(Phase II)	—

Secondary

Measure	Time frame
Phase I - Objective Response Rate of bwDCE ; ORR of bwDCE - Overall response rate after treatment completion - Adverse effect on CTCAE v5.0 Phase II - Overall response rate after treatment completion - Progression Free Survival ( PFS ) - Overall Survival ( OS ) - Treatment completion of chemoradiotherapy - Adverse effect on CTCAE v5.0	—

Contacts

Public ContactTaiji Koyama

Kobe university hospital

hameyama@med.kobe-u.ac.jp+81-78-382-5111

Outcome results

None listed

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