Post-operative Concurrent Chemo-radiotherapy Versus Post-operative Radiotherapy for Cancer of the Head and Neck

• Status: Completed
• Trial end date: 2016-03-31
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of the trial is to determine, in patients who have undergone surgery with curative intent for high-risk CSCC of the head and neck, whether there is a difference in time to loco-regional relapse between patients treated with post-operative concurrent chemo-radiotherapy ,consisting of Carboplatin, and post-operative radiotherapy alone. The target sample size for the trial is 266 patients and will take 3-4 years to accrue, based on an anticipated accrual of 80 patients/year. A further 2 years follow up is required.

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

Details

• Lead Sponsor: Trans Tasman Radiation Oncology Group; Trans-Tasman Radiation Oncology Group (TROG)
• Collaborators: Princess Alexandra Hospital, Brisbane, Australia; The Royal Australian and New Zealand College of Radiologists
• Treatments: Carboplatin

Criteria

Inclusion Criteria:

• Histologically proven SCC

• Patients have undergone either:

• Resection of the primary lesion

• Any type of parotidectomy (superficial, total, partial, etc.)

• Any type of neck dissection(s)

• High risk feature(s); Advanced primary disease or high risk nodal disease

High Risk Nodal Disease

• Intra-parotid nodal disease (any number or size, with/without extracapsular extension, with/without an identifiable index lesion)

• Cervical nodal disease with a synchronous index lesion or previously resected cutaneous primary tumour (<5 years) within the corresponding nodal drainage and a mucosal primary has been excluded with at least a CT +/- MRI and panendoscopy* *For cervical nodal disease to be eligible there must be at least one of the following criteria:

• > 2 nodes

• largest node > 3 cm

• Extracapsular extension

Advanced Primary Disease (TNM 6th Edition 2002) (Appendix 1)

• T3-4 primary disease (cartilage, skeletal, muscle, bone involvement, > 4 cm) of the head and neck including lip, nose and external auditory canal with or without nodal disease

• In transit metastases (metastases between the primary site and the adjoining nodal basin)

• Age > 18 years

• Written informed consent

• ECOG <= 2

• Absolute neutrophil count > 1.5 X 10^9/L, platelet count > 100 X 10^9/L, and haemoglobin > 10 g/dL (pre-radiotherapy blood transfusion to elevate the haemoglobin > 10 g/dL is permissible)

• Calculated creatinine clearance (Cockcroft-Gault) >= 40 mL/min

• Available for follow-up for up to 5 years

• Life expectancy greater than 6 months

Exclusion Criteria:

• Intercurrent illness that will interfere with either the chemotherapy or radiotherapy such as immunosuppression due to medication or medical condition

• Metastasis(es) below the clavicles

• Previous radical radiotherapy to the head and neck, excluding treatment of an early glottic cancer greater than or equal to 2 years ago and superficial radiotherapy to cutaneous SCC or Basal cell carcinoma

• High risk for poor compliance with therapy or follow-up as assessed by investigator

• Pregnant or lactating women

• 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 Level 1 cutaneous melanomas or early glottic cancer > 2 years ago; or non-melanoma skin cancer; or carcinoma in situ of the cervix.

• Low risk cervical nodal disease* without advanced primary disease

*Low risk cervical nodal disease is defined as the presence of all of the following criteria:

• single nodal metastasis

• greater then or equal to 3cm,

• no extracapsular extension