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

Phase 3

Completed

• Conditions: Squamous Cell Carcinoma of the Head & Neck (Skin Cancer); Cancer - Head and neck

• Registration Number: ACTRN12607000146493
• Lead Sponsor: Trans Tasman Radiation Oncology Group (TROG)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-02-26
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

1. Histologically proven Squamous Cell Carcinoma
2. Complete macroscpoic resection of all known disease with or withour microscpoic positive margins. Surgery may consist of one or more of the following:a)Resection of the primary lesion; b) Any type of parotidectomy (superficial, total, partial, etc.); c) Any type of neck dissection(s)
3. High risk feature(s); high risk nodal disease and/or advanced primary disease: a) High Risk Nodal Disease
Intra-parotid nodal disease (any number or size, with/without extracapsular extension, with/without an identifiable index lesion)
b) 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 Computed Tomography (CT) +/- Magnetic Resonance Imaging (MRI) and panendoscopy*
* For cervical nodal disease to be eligible there must be at least one of the following
criteria:
(i) > 2 nodes
(ii) largest node > 3cm
(iii) Extracapsular extension
c) Advanced Primary Disease (Tumor, Node, Metastasis (TNM) 6th Edition 2002) (Appendix 1)
T3-4 primary disease (cartilage, skeletal, muscle, bone involvement, >4cm) of the
head and neck including lip, nose and external auditory canal with or without nodal
disease
d) In transit metastases (metastases between the primary site and the adjoining nodal basin)
4. Age >18 years
5. Written informed consent
6. Eastern Cooperative Oncology Group (ECOG) < 2
7. Absolute neutrophil count > 1.5 X 109/L, platelet count > 100 X 109/L, and haemoglobin > 10g/dL (pre-radiotherapy blood transfusion to elevate the haemoglobin > 10g/dL is permissible)
8. Calculated creatinine clearance (Cockcroft-Gault) >40mL/min
9. Available for follow-up for up to 5 years
10. Life expectancy greater than 6 months.

Exclusion Criteria

1. Intercurrent illness that will interfere with either the chemotherapy or radiotherapy
such as immunosuppression due to medication or medical condition
2. Metastasis(es) below the clavicle
3. Previous radical radiotherapy to the head and neck, excluding treatment of an early glottic cancer > 2 years ago and superficial radiotherapy to cutaneous Squamous Cell Carcinoma (SCC) or basal cell carcinoma
4. High risk for poor compliance with therapy or follow-up as assessed by investigator
5. Pregnant or lactating women
6. 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.
7. 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;
(i) single nodal metastasis,
(ii) < 3 cm,
(iii) no extracapsular extension.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
oco-regional relapse - Time to loco-regional relapse from the date of randomisation.[Follow up visits are scheduled at 4, 8 and 12 weeks, then 6, 9, 12, 16, 20 and 24 months from completion of treatment and then 6 monthly intervals until the final patient has reached a minimum of 2 years follow up.]