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

Phase 2

Completed

• Conditions: Squamous Cell Carcinoma of the Skin; Cancer - Other cancer types

• Registration Number: ACTRN12607000534482
• Lead Sponsor: Michelle Nottage

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-10-18
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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.
Disease deemed unsuitable for surgical resection

Exclusion Criteria

Co-morbid conditions precluding safe administration of trial therapy
Previous chemo- or radiotherapy to head and neck region precluding re-treatment
Pregnancy/lactation

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Complete Response Rate[8weeks after completion of therapy]

Secondary Outcome Measures

Name	Time	Method
Overall Survival[3years];Disease-free Survival[3years];Toxicity according to Common Toxicity Criteria Version 3.0[Acute toxicity monitored daily for the 7 weeks of radiation therapy, then at 4,8 & 12 weeks after completion of therapy. Late toxicity monitored every 2months for first year and every 3rd month for thereafter]