Induction Chemotherapy Followed by Cetuximab Plus Definitive Radiotherapy Versus Radiation Plus Cisplatin

• Status: Active, not recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

A phase III trial of induction chemotherapy followed by definitive radiotherapy plus Cetuximab versus chemoradiation in unresectable, locally advanced, squamous cell carcinoma of the head and neck (HNC).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gruppo Oncologico del Nord-Ovest
• Treatments: Cetuximab; Cisplatin; Docetaxel; Fluorouracil

Criteria

Inclusion Criteria:

• > 18 years of age

• Histologically or cytologically confirmed diagnosis of HNSCC

• Stage III/IV, not suitable for surgery (definitive cure rate improbable, technically unresectable or medical contraindication for surgery)

• At least one uni-dimensional measurable lesion either by CT scan or MRI

• Signed written informed consents prior to beginning protocol

Specific procedures:

• Tumor tissue available for immunohistochemical staining of EGFR expression and HPV

• Life expectancy of > 3 months at study entry

• ECOG Performance Status of <2 at study entry.

• Effective contraception if risk of conception exists.

• Neutrophils > 2.0/mm³, platelet count > 100,000/mm³, and hemoglobin > 10 g/dl

• Normal liver function

• Serum creatinine > 1.25 x ULN and/or creatinine clearance > 60 ml/min

Exclusion Criteria:

• Prior systemic chemotherapy and/or radiotherapy

• Known peripheral neuropathy > grade 2 NCI-CTC version 3.0

• Known chronic heart failure

• Prior surgery, excluding prior diagnostic biopsy

• Known drug abuse

• Active uncontrolled infection

• Other concomitant anticancer therapy

• Distant metastasis

• Concurrent chronic systemic immune therapy, chemotherapy for disease other than cancer, or hormone therapy not indicated in the study protocol

• Clinically relevant coronary artery disease or history of a myocardial infarction within the last 12 months before study entry

• Medical or psychological condition that would not permit the patient to complete the trial or sign informed consent

• Nasopharyngeal carcinoma WHO type II or III

• Known allergic reaction against any of the components of the treatment

• Pregnancy (absence confirmed by beta-HCG test) or lactation period

• Any prior or on-going investigational medication

• Previous or current malignancy except basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix