NCT00193895

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
321

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Apr 2005

Longer than P75 for phase_3

Geographic Reach
2 countries

21 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
10.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2016

Completed
Last Updated

April 6, 2018

Status Verified

April 1, 2018

Enrollment Period

10.9 years

First QC Date

September 13, 2005

Last Update Submit

April 4, 2018

Conditions

Skin Cancer

Keywords

Skin cancerradiotherapychemotherapysurgery

Outcome Measures

Primary Outcomes (1)

  • Loco-regional Control

    The date of primary outcome analysis will occur when the final patient has reached a minimum 2 years follow-up.

Secondary Outcomes (4)

  • Disease Free Survival

    The date of analysis will occur when the final patient has reached a minimum 2 years follow-up.

  • Overall Survival

    The date of analysis will occur when the final patient has reached a minimum 2 years follow-up.

  • Quality of Life

    The date of analysis will occur when the final patient has reached a minimum 2 years follow-up.

  • Treatment-related Late Effects

    The date of analysis will occur when the final patient has reached a minimum 2 years follow-up.

Study Arms (2)

Radiotherapy alone

ACTIVE COMPARATOR

Radiotherapy alone (60Gy or 66Gy in 30-33 fractions 5-5/week)

Radiation: Radiotherapy

Radiotherapy plus chemotherapy

EXPERIMENTAL

Radiotherapy plus chemotherapy (Radiotherapy 60Gy or 66Gy in 30-33 fractions 5/week + Carboplatin (AUC 2) intravenously weekly)

Drug: CarboplatinRadiation: Radiotherapy

Interventions

CarboplatinDRUG

Carboplatin will commence with a dose calculated to target an AUC of 2.0. A maximum of 6 doses of weekly Carboplatin will be given. Carboplatin will be administered intravenously over 20-30 minutes prior to radiation therapy.

Also known as: Carboplatin Ebewe, Injection
Radiotherapy plus chemotherapy
RadiotherapyRADIATION

60 Gy OR 66Gy in 2Gy/fraction 5days/week

Also known as: Radiation
Radiotherapy aloneRadiotherapy plus chemotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)
  • +7 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

Liverpool Hospital

Liverpool, New South Wales, 1871, Australia

Location

Calvary Mater Newcastle

Newcastle, New South Wales, 2298, Australia

Location

Royal North Shore Hospital

St Leonards, New South Wales, 2065, Australia

Location

Royal Prince Alfred Hospital

Sydney, New South Wales, 2050, Australia

Location

Riverina Cancer Centre

Wagga Wagga, New South Wales, 2650, Australia

Location

Westmead Hospital

Wentworthville, New South Wales, 2145, Australia

Location

Illawarra Cancer Care Centre

Wollongong, New South Wales, 2500, Australia

Location

Princess Alexandra Hospital

Brisbane, Queensland, 4102, Australia

Location

Royal Brisbane Hospital

Herston, Queensland, 4029, Australia

Location

Mater QRI

South Brisbane, Queensland, 4101, Australia

Location

St Andrew's Toowoomba Hospital

Toowoomba, Queensland, 4350, Australia

Location

North Queensland Oncology Service

Townsville, Queensland, 4810, Australia

Location

Genesis Cancer Care (previously Premion)

Tugun, Queensland, 4224, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Peter MacCallum Cancer Centre

East Melbourne, Victoria, 3002, Australia

Location

Andrew Love Cancer Care Centre, Geelong Hospital

Geelong, Victoria, 3220, Australia

Location

William Buckland Radiotherapy Centre, The Alfred

Melbourne, Victoria, 3004, Australia

Location

Auckland Hospital

Auckland, 1001, New Zealand

Location

Christchurch Hospital

Christchurch, 4710, New Zealand

Location

Waikato Hospital

Hamilton, 3200, New Zealand

Location

Palmerston North Hospital

Palmerston North, New Zealand

Location

Related Publications (2)

  • Porceddu SV, Connolly E, Bressel M, Wratten C, Liu HY, Rischin D. Prognostic Subgroups for Disease-Free Survival With Cutaneous Squamous Cell Carcinoma of the Head and Neck: A Secondary Analysis of a Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2025 Oct 1;151(10):938-945. doi: 10.1001/jamaoto.2025.2110.

    PMID: 40875250DERIVED

  • Porceddu SV, Bressel M, Poulsen MG, Stoneley A, Veness MJ, Kenny LM, Wratten C, Corry J, Cooper S, Fogarty GB, Collins M, Collins MK, Macann AMJ, Milross CG, Penniment MG, Liu HY, King MT, Panizza BJ, Rischin D. Postoperative Concurrent Chemoradiotherapy Versus Postoperative Radiotherapy in High-Risk Cutaneous Squamous Cell Carcinoma of the Head and Neck: The Randomized Phase III TROG 05.01 Trial. J Clin Oncol. 2018 May 1;36(13):1275-1283. doi: 10.1200/JCO.2017.77.0941. Epub 2018 Mar 14.

    PMID: 29537906DERIVED

Related Links

MeSH Terms

Conditions

Skin Neoplasms

Interventions

CarboplatinInjectionsRadiotherapyRadiation

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsDrug Administration RoutesDrug TherapyTherapeuticsPhysical Phenomena

Study Officials

  • Sandro Porceddu

    Princess Alexandra Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 19, 2005

Study Start

April 1, 2005

Primary Completion

March 1, 2016

Study Completion

March 31, 2016

Last Updated

April 6, 2018

Record last verified: 2018-04

Locations

AU(17)NZ(4)