Chemoradiation Treatment for Head and Neck Cancer

Trans Tasman Radiation Oncology Group

Status and phase

Completed

Phase 2

Phase 1

Conditions

Head and Neck Cancer

Treatments

Radiation: Radiotherapy

Drug: Carboplatin

Drug: Cetuximab

Study type

Interventional

Funder types

Other

Identifiers

NCT00704639

TROG 07.04

Details and patient eligibility

About

This is a Phase II study of cetuximab, carboplatin and radiotherapy (RT) in patients with Locally Advanced Head and Neck Carcinomas (LAHNC) who are unfit for cisplatin.

The aim of this study is to show the feasibility and safety profile of the combination of cetuximab, carboplatin and RT in treatment of patients with LAHNC.

Full description

Secondary objectives are to estimate failure free survival (FFS) and overall survival, to evaluate the time to local and regional failure and to determine the site of first failure (characterised as local, regional, distant or combinations). Acute and late treatment toxicities will also be evaluated.

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Previously untreated SCC of the oropharynx, larynx or hypopharynx.
Stage III or IV, excluding T1N1, and metastatic disease (to be confirmed by a chest CT, and abdominal CT or ultrasound scan if patients with abnormal liver function tests or a bone scan or FDG-PET if patients with bone pain).
Histologically or cytologically confirmed HNSCC
Disease must be considered potentially curable by chemoradiation
Patients medically unfit for cisplatin chemotherapy due to one or more of the following reasons:
- Clinically significant sensori-neural hearing impairment (audiometric abnormalities without corresponding clinical deafness will not be regarded as a contraindication to cisplatin)
- Severe tinnitus
- Renal impairment (GFR < 60ml/min)
- Peripheral neuropathy > grade 2
- Inability to tolerate intravenous hydration eg due to cardiac disease
- Co-morbidities (based on clinical judgement by the investigator) associated with ECOG PS 2 that in the view of the investigator would preclude the safe administration of cisplatin
Performance status ECOG 0, 1 or 2.
Adequate haematological, renal and hepatic functions as defined by:
- Absolute neutrophil count (ANC, segmented cells (segs) + bands)>= 1.5 x 109/L
- Platelet count >= 100 x 109/L
- Total bilirubin <= 1.5 x upper normal limit
- Alanine aminotransferase <= 2.5 x upper normal limit
- Calculated creatinine clearance > 40ml/min (Cockcroft-Gault formula).
- If calculated creatinine clearance < 50 ml/min, glomerular filtration rate to be measured with DTPA or EDTA scan. If < 40 ml/min not eligible.
Age >18 years
Signed written consent
Suitable for follow-up for 4 years in the view of the investigator

Exclusion criteria

Distant metastases, i.e., any metastatic disease below the clavicles. Patients with lung nodules >10mm will be excluded unless non-malignancy aetiology is established. Patients with lesions 5-10mm can be included if a FDG-PET scan is negative and the investigator considers on clinical grounds that metastasis is unlikely. Patients with lesions < 5mm can be included if the investigator considers on clinical grounds that metastases are unlikely. Patients with multiple lung nodules should not be included unless there is a strong case that these do not represent metastases, e.g., stable on imaging for over 12 months, non-malignant aetiology apparent. The level of clinical suspicion may be influenced by clinical stage, e.g., N3 disease, low neck nodes. In general if there is any doubt patients should be excluded.
Previous radical RT to the head & neck region, excluding superficial RT for a non-melanomatous skin cancer.
Patients with prior cancers, except: those diagnosed > 5 years ago with no evidence of disease recurrence and clinical expectation of recurrence of less than 5%; or successfully treated non-melanoma skin cancer; or carcinoma in situ of the cervix.
Significant intercurrent illness that will interfere with the chemotherapy or radiation therapy such as HIV infection, cardiac failure, pulmonary compromise, active infection
Any history of myocardial infarction, ventricular arrhythmias, or unstable angina within the last 6 months
Pregnant or lactating women.
Weight loss greater than 20 % of usual body weight in the 3 months preceding trial entry
High risk for poor compliance with therapy or follow up as assessed by the investigator
Prior radiation to greater than 30% of the bone marrow
Prior systemic chemotherapy for cancer
Refusal by male or female patients, to use appropriate contraception during the study and for 3 months afterwards
Any condition or circumstance which might prevent the patient being able to give valid informed consent, or from completing participation in the study