CompletedPhase 2ACTRN12607000534482

A Prospective Study Investigating the Impact of Definitive Chemoradiation in Locally and/or Regionally Advanced Squamous Cell Carcinoma of the Skin

A Prospective Nonrandomised Study Investigating the Impact of Definitive Chemoradiation Using Cisplatin or Carboplatin on Complete Response Rate in Patients with Locally and/or Regionally Advanced Squamous Cell Carcinoma of the Skin


Sponsor

Michelle Nottage

Enrollment

30 participants

Start Date

Jan 26, 2009

Study Type

Interventional

Conditions

Summary

Phase 2 This is a study of the effectiveness and toxicity of chemoradiation therapy for skin cancer (squamous cell carcinoma). Who is it for? You can join this study if you have squamous cell skin cancer that cannot be treated surgically. Trial details Participants will receive chemotherapy with the drugs cisplatin or carboplatin once per week for 6 weeks as well as daily radiotherapy. There is no control group in this study. Participants' response to treatment will be measured 8 weeks after treatment is completed. Side effects will be monitored during treatment, at 4, 8 and 12 weeks after treatment is completed, and then every 2 months for the first year, and every three months after that. Overall survival and disease free survival will be measured after 3 years. The study aims to document the effectiveness and toxicity of treatment with combined chemotherapy and radiotherapy.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is about a Prospective Study Investigating the Impact of Definitive Chemoradiation in Locally and/or Regionally Advanced Squamous Cell Carcinoma of the Skin. It is looking for adults aged 18 and older to participate. To join, participants should meet requirements such as: Patients with cutaneous squamous cell carcinoma with locally-advanced disease at the primary site +/-nodal metastases, or advanced regional node metastases of presumed skin origin. Participants will be guided through the study procedures by the research team and may need to attend scheduled visits.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Cisplatin 40mg/m2 given intravenously once per week concurrent with radiation therapy for 6 weekly doses Carboplatin at a dose of AUC2 given intravenously once a week for 6 weekly doses concurrent wi

Cisplatin 40mg/m2 given intravenously once per week concurrent with radiation therapy for 6 weekly doses Carboplatin at a dose of AUC2 given intravenously once a week for 6 weekly doses concurrent with radiotherapy, for patients where cisplatin is contraindicated


Locations(1)

QLD, Australia

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