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Skin CancerPhase 3NCT00193895

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

A Phase 3 study testing Carboplatin and Radiotherapy in people with Skin Cancer, run by Trans Tasman Radiation Oncology Group at 21 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Skin Cancer
What is being tested?
Carboplatin and Radiotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
321 participants
Where
21 sitesin 2 countries
Study dates
Apr 2005to 31 Mar 2016
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 22Show fewer
  • 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

Who cannot join

  • 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.
Show all 11Show fewer
  • 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

Trial locations and contacts

21 sites in 2 countries.

21 sites in 2 countries

Australia17 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Princess Alexandra Hospital

    Brisbane, Queensland, 4102

  • Peter MacCallum Cancer Centre

    East Melbourne, Victoria, 3002

  • Andrew Love Cancer Care Centre, Geelong Hospital

    Geelong, Victoria, 3220

  • Royal Brisbane Hospital

    Herston, Queensland, 4029

  • Liverpool Hospital

    Liverpool, New South Wales, 1871

  • William Buckland Radiotherapy Centre, The Alfred

    Melbourne, Victoria, 3004

  • Calvary Mater Newcastle

    Newcastle, New South Wales, 2298

  • Mater QRI

    South Brisbane, Queensland, 4101

  • Royal North Shore Hospital

    St Leonards, New South Wales, 2065

  • Royal Prince Alfred Hospital

    Sydney, New South Wales, 2050

  • St Andrew's Toowoomba Hospital

    Toowoomba, Queensland, 4350

  • North Queensland Oncology Service

    Townsville, Queensland, 4810

  • Genesis Cancer Care (previously Premion)

    Tugun, Queensland, 4224

  • Riverina Cancer Centre

    Wagga Wagga, New South Wales, 2650

  • Westmead Hospital

    Wentworthville, New South Wales, 2145

  • Illawarra Cancer Care Centre

    Wollongong, New South Wales, 2500

Other trials in Australia

New Zealand4 sites

  • Auckland Hospital

    Auckland, 1001

  • Christchurch Hospital

    Christchurch, 4710

  • Waikato Hospital

    Hamilton, 3200

  • Palmerston North Hospital

    Palmerston North

Other trials in New Zealand

About this study

Official title: Post-operative Concurrent Chemo-radiotherapy Versus Post-operative Radiotherapy in High-risk Cutaneous Squamous Cell Carcinoma of the Head and Neck

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.

Read the detailed description

Two in every 3 Australians will be affected by skin cancer over their lifetime. The prevalence of skin cancer will continue to increase due to the ageing population and represents a significant problem in our community. Cure of early (T1-2) de novo cutaneous squamous cell carcinoma (CSCC) treated with either curative intent surgery or radiotherapy is 85-100%. However, the cure rate for locally advanced, recurrent, or metastatic disease to regional nodes following surgery alone are much lower, in the order of 20-70%. Metastatic CSCC is the most common malignancy of the parotid region in Australia. The 5 year loco-regional control with surgery alone is in the order of 40%-45%. The addition of post-operative radiotherapy improves loco-regional control by 15-20%, and is therefore considered the standard of care in this group of patients.

Recent data have shown that synchronous post-operative chemo-radiotherapy is superior to post-operative radiotherapy alone in "high-risk" mucosal head and neck squamous cell carcinoma (HNSCC). However, to date, there is no evidence from randomised trials that such a benefit exists in CSCC of the head and neck. At present there is little consensus amongst clinicians in Australia as to who should receive post-operative chemo-radiotherapy in CSCC. Although tumour control rates may be improved, the addition of chemotherapy may also significantly increase treatment related toxicity. Nonetheless, some centres have adopted the use of post-operative chemo-radiotherapy in selected patients with CSCC based on extrapolation from mucosal sites. This has resulted in a wide variability in practice for this disease.

Australia is uniquely placed to perform such a trial comparing post-operative chemo-radiotherapy to post-operative radiotherapy alone in high-risk CSCC due to the high rate of skin cancer. Currently there are limited data to guide management of patients with resected CSCC who are at high risk for recurrence. While it is reasonable to hypothesize that concurrent chemotherapy in this setting will confer a similar benefit to that seen in mucosal HNSCC, this can only be established by a randomized trial as proposed. If the addition of chemotherapy is shown to be beneficial and safe, then these results are likely to be translated into standard practice both nationally and internationally quite rapidly. On the other hand, if the treatment is found to be ineffective then patients will be spared the unnecessary toxicity and inconvenience associated with the addition of chemotherapy. A further important aspect of this trial will be the assessment of patient-related outcomes using a validated quality of life questionnaire. It will be important to ascertain whether any improvement in locoregional control due to the addition of chemotherapy, is also associated with improvement in quality of life compared to the control arm.

Conditions
Skin Cancer
Being tested
Carboplatin, Radiotherapy
Keywords
Skin cancer, radiotherapy, chemotherapy, surgery
Medical subject headings
Skin Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CarboplatinDrug

    Also called Carboplatin Ebewe, Injection

    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.

  • RadiotherapyRadiation

    Also called Radiation

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

Study groups in NCT00193895
Study groupRoleWhat they receive
Radiotherapy aloneActive comparatorRadiotherapy alone (60Gy or 66Gy in 30-33 fractions 5-5/week)
Receives: Radiation: Radiotherapy
Radiotherapy plus chemotherapyExperimentalRadiotherapy plus chemotherapy (Radiotherapy 60Gy or 66Gy in 30-33 fractions 5/week + Carboplatin (AUC 2) intravenously weekly)
Receives: Drug: Carboplatin; Radiation: Radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Loco-regional Control

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

Secondary outcomes (4)

  1. Disease Free Survival

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

  2. Overall Survival

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

  3. Quality of Life

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

  4. Treatment-related Late Effects

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2005 (estimated)
  2. Study startApr 2005
  3. Primary completionMar 2016
  4. Study completion31 Mar 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
321 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00193895
Sponsor's protocol ID
TROG 05.01
Status last verified
Apr 2018
First submitted
13 Sep 2005
Last updated
6 Apr 2018
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 40875250

  • 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.

    PubMed 29537906

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Carboplatin and Radiotherapy in people with Skin Cancer, run by Trans Tasman Radiation Oncology Group at 21 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00193895, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2018.

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