Cetuximab Plus Radiotherapy Versus Cisplatin Plus Radiotherapy in Locally Advanced Head and Neck Cancer

• Status: Terminated
• Trial end date: 2015-05-20
• Target enrollment: 0
• Participant gender: All

Summary

BACKGROUND:

Concomitant radiotherapy and cisplatin (CDDP) based chemotherapy is the standard treatment for LA-NHSCC. This combined modality treatment is linked with considerable acute local and systemic toxicity.EGFR is overexpressed in 90-100% of the HNSCC cases and is considered an unfavourable prognostic marker. EGFR costitutive activation is linked with HNSCC pathogenesis.

Cetuximab is a monoclonal anti-EGFR antibody blocking the activation of the receptor and signal transduction. Cetuximab combined with radiotherapy is superior to radiotherapy only in the treatment of LA-HNSCC and is characterized by an acceptable toxicity profile.

RATIONALE:

A direct comparison between concomitant chemoradiotherapy with Cisplatin and the concomitant treatment with radiotherapy associated to cetuximab does not exist.

STUDY DESIGN:

Arm A: Radical radiotherapy (doses and volumes) concomitant with chemotherapy with Cisplatin (40 mg/mq/week) Arm B: Radical radiotherapy (doses and volumes) concomitant with therapy with the monoclonal antibody Cetuximab (400 mg/m2 ["loading dose"] and subsequently 250 mg /m2/week)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Azienda USL 4 Prato
• Collaborator: Università degli Studi di Brescia
• Treatments: Cetuximab; Cisplatin

Criteria

Inclusion Criteria:

• Histologically confirmed squamous cell carcinoma (with biopsy on the primary and / or lymph node metastases) of the oral cavity, oropharynx, hypopharynx, larynx supraglottix;

• Locally advanced disease, defined by one of the following criteria: any T, N +, M0 (excluding T1, N1), T3-4, N0, M0;

• Not cancer nasopharynx or paranasal sinuses or salivary glands;

• General conditions and associated diseases which does not allow to perform chemotherapy or radiotherapy in a radical view;

• No other surgical treatments, chemotherapy or radiotherapy for cancer of head and neck or elsewhere, except non-melanoma skin cancer or in situ cervical cancer and other solid tumors for which radical treatment has been completed > three years prior to enrollment in the study and for which the patient has remained continuously free of disease;

• Accessibility to follow-up;

• Signing of informed consent;

• Interval between examinations of local staging and randomization, maximum 3 weeks

• Interval between randomization and initiation of treatment, maximum 2 weeks

Exclusion Criteria:

• Age <18 years

• ECOG performance status > 0-1

• Hemoglobin <9 g / dL

• Counts of granulocytes, total <1.5 x 10 ^ 9 / L

• Platelet count <100 x 10 ^ 9 / L

• Bilirubin> 1.5 times upper limit of normal (ULN)

• AST or ALT> 3 times ULN

• Creatinine clearance > 50 mL/min

• Mg > 0.5 mmol/L

• Pregnancy or lactation

• Presence of allergy to study drug or to the excipients used in their formulation

• Peripheral neuropathy ≥ grade 2 (CTCAE v3.0)

• Hearing loss / tinnitus ≥ grade 3 (CTCAE v3.0)

• One of the following conditions:

• Myocardial infarction within 12 months prior to randomization

• Severe congestive heart failure

• Unstable angina

• Cardiomyopathy in act

• Ventricular arrhythmia

• uncontrolled hypertension

• Severe psychotic disorders in act

• Severe infection in act

• Any other serious illness that could interfere with the administration of the therapy provided by the protocol