Feasibility study evaluating Paclitaxel, Carboplatin and Cetuximab (PCE) as induction chemotherapy followed by chemoradiation in patients with Unresectable Locally advanced Squamous Cell Carcinoma of the Head and Neck

Feasibility study evaluating Paclitaxel, Carboplatin and Cetuximab (PCE) as induction chemotherapy followed by chemoradiation in patients with Unresectable Locally advanced Squamous Cell Carcinoma of the Head and Neck - Feasibility study evaluating Paclitaxel, Carboplatin and Cetuximab (PCE) as induction chemotherapy followed by chemoradiation in patients with Unresectable Locally advanced Squamous Cell Carcinoma of the Head and Neck (IC-PCE)

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000014430

Enrollment

Registered

2014-07-02

Start date

2014-06-14

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

Paclitaxel, Carboplatin and Cetuximab (PCE) followed by Cisplatin and Radiation

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Histologically or cytological proven squamous cell carcinoma of the head and neck. 2)Primary lesion located at the larynx,oropharynx or hypopharynx. 3)Unresectable LASCCHN. 4)No cancer fistula. 5)Measurable disease. 6)No evidence of distant metastasis. 7)ECOG PS 0 or 1. 8)Age between 20 and 75 years. 9)Adequate organ function. 10)HBsAg negative. 11)No abnormal finding on electrocardiogram. 12)Women of child bearing potential and men who are able to father a child agree with using adequate contraception. 13)Written informed consent to the study signed by the patient.

Exclusion criteria

Exclusion criteria: 1)Primary lesion located at the nasopharynx, oral cavity, nasal cavity, parasinus or salivary gland. 2)Prior RT, CT or endocrine therapy for the current or any other malignancy . 3)Current other synchronous primary double cancers and metachronous double cancers unless free of disease for at least five years (excluding superficial cancer that will be cured by endoscopic mucosal resection). 4)Severe myelosuppressifon or infection. 5)Pulmonary fibrosis, acute lung injury or Intestinal pneumonia . 7)Active gastrointestinal bleeding. 8)Clinically relevant comorbidity included heart failure, renal failure, liver failure, uncontrolled hypertension or uncontrolled diabetes mellitus. 9)History of severe hypersensitivity. 10)Known hypersensitivity against any components of the trial treatment including excepients. 11)Pregnancy or breast feeding. 12)Current administration of disulfiram, Cyanamide, Carmofur or procarbazine hydrochloride. 13)Previous treatment with cetuximab or monoclonal antibody. 14)Other significant disease that in the investigator's opinion would exclude the subject from the trial.

Design outcomes

Primary

Measure	Time frame
Proportion of chemoradiation completion	—

Secondary

Measure	Time frame
Response rate, Frequency and types of adverse events, Time-to-local progression, Time-to-distant metastasis, Event-free survival, Overall survival	—

Countries

Japan

Contacts

Public ContactTomohiro Enokida

National Cancer Center Hospital East Division of Head and Neck Medical Oncology

tenokida@east.ncc.go.jp+81-4-7133-1111

Outcome results

None listed

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