The primary objective of the trial is to determine, in patients who have undergone surgery with curative intent for high-risk cutaneous squamous cell carcinoma (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.

Official Title

Post-Operative Concurrent Chemo-Radiotherapy Versus Post-Operative Radiotherapy in High-Risk Cutaneous Squamous Cell Carcinoma of the Head and Neck

Conditions

Squamous Cell Carcinoma (skin cancer)

Study Type

Interventional

Study Design

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Further Details

Primary Outcome Measures:

  • Loco-regional Control [Time Frame: The date of primary outcome analysis will occur when the final patient has reached a minimum 2 years follow-up.]

Secondary Outcome Measures:

  • Disease Free Survival [Time Frame: The date of analysis will occur when the final patient has reached a minimum 2 years follow-up.]
  • Overall Survival [Time Frame: The date of analysis will occur when the final patient has reached a minimum 2 years follow-up.]
  • Quality of Life [Time Frame: The date of analysis will occur when the final patient has reached a minimum 2 years follow-up.]
  • Treatment-related Late Effects [Time Frame: The date of analysis will occur when the final patient has reached a minimum 2 years follow-up.]

Study Start

May 2005; Expected completion: May 2010

Eligibility & Criteria

  • Ages Eligible for Study: 18 Years and above
  • Genders Eligible for Study: Both

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)
  • One or more of the following high risk features:
    • High Risk Nodal Disease, defined as:
      • Intra-parotid nodal disease (any number or size, with/without extracapsular extension, with/without an identifiable index lesion)
      • Cervical nodal disease with a synchronous or previously (< 2 years) resected index lesion within the corresponding nodal drainage basin and exclusion of a mucosal primary with at least a CT+/- MRI and panendoscopy
    • Cervical nodal disease, with at least one of the following criteria:
      • > 2 nodes
      • largest node > 3cm
      • Extracapsular extension
    • Advanced Primary Disease (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
      • 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 109/L, platelet count > 100 X 109/L, and haemoglobin > 10g/dL (pre-radiotherapy blood transfusion to elevate the haemoglobin > 10g/dL is permissible)
  • Calculated creatinine clearance (Cockcroft-Gault) >= 40mL/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 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 > 5years 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.

Total Enrolment

265

Contact Details

New South Wales

  • Royal Prince Alfred Hospital, Sydney, New South Wales, 2050, Australia; Recruiting
  • Liverpool Hospital, Liverpool, New South Wales, 1871, Australia; Recruiting
  • Newcastle Mater Misericordiae Hospital, Newcastle, New South Wales, 2298, Australia; Recruiting
  • St George Hospital, Kogarah, New South Wales, 2217, Australia; Recruiting
  • Westmead Hospital, Wentworthville, New South Wales, 2145, Australia; Recruiting

Queensland

  • Princess Alexandra Hospital, Brisbane, Queensland, 4102, Australia; Recruiting
  • Mater QRI, South Brisbane, Queensland, 4101, Australia; Recruiting
  • North Queensland Oncology Service, Townsville, Queensland, 4810, Australia; Recruiting
  • Royal Brisbane Hospital, Herston, Queensland, 4029, Australia; Recruiting
  • The John Flynn Hospital, Tugun, Queensland, 4224, Australia; Recruiting

South Australia

  • Royal Adelaide Hospital, Adelaide, South Australia, 5000, Australia; Recruiting

Victoria

  • Peter MacCallum Cancer Centre, East Melbourne, Victoria, 3002, Australia; Recruiting
  • Andrew Love Cancer Care Centre, Geelong Hospital, Geelong, Victoria, 3220, Australia; Recruiting
  • St Vincents Melbourne, Fitzroy, Victoria, Australia; Not yet recruiting
  • Bendigo Radiotherapy Centre, Bendigo, Victoria, Australia; Not yet recruiting

New Zealand

  • Auckland Hospital, Auckland, 1001, New Zealand; Recruiting
  • Christchurch Hospital, Christchurch, 4710, New Zealand; Recruiting
  • Palmerston North Hospital, Palmerston North, New Zealand; Recruiting
  • Waikato Hospital, Hamilton, 3200, New Zealand; Recruiting

For more information:

  • Contact Sandro Porceddu, FRANZCR: +61 7 3240 2111; sandro_porceddu@health.qld.gov.au
  • OR

  • visit TROG Trials (Trial #: TROG 05.01).