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

JRCT ID: jRCTs031180358

Registered date:18/03/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Unresectable Locally advanced Squamous Cell Carcinoma of the Head and Neck
• Date of first enrollment: 18/06/2014
• Target sample size: 46
• Study type: Interventional
• Intervention(s): Paclitaxel, Carboplatin and Cetuximab (PCE) followed by Cisplatin and Radiation

Outcome(s)

• Primary Outcome: Proportion of chemoradiation completion

Secondary Outcome

Response rate
Frequency and types of adverse events
Time to local progression
Time to distant metastasis
Event free survival
Overall survival

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 75age old
• Gender: Both

Include 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

Exclude 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 myelosuppression or infection
5) Pulmonary fibrosis, acute lung injury or Intestinal pneumonia
6) Clinically relevant comorbidity included heart failure, renal failure, liver failure, uncontrolled hypertension or uncontrolled diabetes mellitus
7) Active gastrointestinal bleeding
8) Cardiac or peritoneal effusion that needs medical attention
9) History of severe hypersensitivity
10) Known hypersensitivity against any components of the trial treatment including excipients
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

Related Information

• Primary Sponsor: Tahara Makoto