Chemoradiation Treatment for Head and Neck Cancer

Phase 2

Completed

• Conditions: ocally Advanced Head and Neck Squamous Cell Carcinoma; Locally Advanced Head and Neck Squamous Cell Carcinoma; Cancer - Head and neck

• Registration Number: ACTRN12613000695707
• Lead Sponsor: Trans Tasman Radiation Oncology Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-06-25
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Previously untreated Squamous Cell Carcinoma (SCC) of the oropharynx, larynx or hypopharynx.
2. 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 Flurodeoxyglucose Positron Emission Tomography (FDG-PET) if patients with bone pain).
3. Histologically or cytologically confirmed Head and Neck SCC
4. Disease must be considered potentially curable by chemoradiation
5. 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 (Glomerular Filtration Rate (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 Eastern Cooperative Oncology Group Performance Status (ECOG PS) 2 that in the view of the investigator would preclude the safe administration of cisplatin
6. Performance status ECOG 0, 1 or 2.
7. Adequate haematological, renal and hepatic functions as defined by:
- Absolute neutrophil count (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 Diethylene triamine pentaacetic acid (DTPA) or Ethylenediaminetetraacetic acid (EDTA) scan. If < 40 ml/min not eligible.
8. Age >18 years
9. Signed written consent
10. Suitable for follow-up for 4 years in the view of the investigator

Exclusion Criteria

1. 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 flurodeoxyglucose positron emission tomography (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.
2. Previous radical radiotherapy (RT) to the head & neck region, excluding superficial RT for a non-melanomatous skin cancer.
3. 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.
4. Significant intercurrent illness that will interfere with the chemotherapy or radiation therapy such as Humman Immunodeficiency virus (HIV) infection, cardiac failure, pulmonary compromise, active infection
5. Any history of myocardial infarction, ventricular arrhythmias, or unstable angina within the last 6 months
6. Pregnant or lactating women.
7. Weight loss greater than 20 % of usual body weight in the 3 months preceding trial entry
8. High risk for poor compliance with therapy or follow up as assessed by the investigator
9. Prior radiation to greater than 30% of the bone marrow
10. Prior systemic chemotherapy for cancer
11. Refusal by male or female patients, to use appropriate contraception during the study and for 3 months afterwards
12. Any condition or circumstance which might prevent the patient being able to give valid informed consent, or from completing participation in the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety and Feasibility. Measured as satisfactory completion of the protocol treatment regimen[An initial 6 patients will be treated. Once all these patients have a 2 week post radiotherapy review there will be analysis. If <= 1 patient has a Dose Limiting Toxicity (DLT) than the treatment is deemed safe.]