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Trial Details
Trial status:
Closed
Recruitment start date:
04/03/2016
Funder:
Cancer Research UK
Sponsor:
UCL
Chief Investigator:
Dr Beatrice Seddon
Recruitment target:
200
EudraCT number:
N/A
Contact details:
ctc.imris@ucl.ac.uk
Lay summary:
IMRiS
A phase II study of intensity modulated radiotherapy (IMRT) in primary bone and soft tissue sarcoma
Description
Design: This was a prospective multicentre phase II trial of intensity modulated radiotherapy (IMRT) in patients with bone or soft tissue sarcoma, split into 3 cohorts
Treatment:
Cohort 1 
  • Pre-operative RT – 50 Gy in 25 daily fractions over 5 weeks 
  • Post-operative RT – 60 Gy in 30 daily fractions to the high dose planning target volume (PTV) and 52.2 Gy in 30 daily fractions to the low dose PTV treated concurrently over 6 weeks 
  • Post-operative RT (positive resection margins) – 66 Gy in 33 daily fractions to the high dose PTV, and 53.46Gy in 33 fractions to the low dose PTV treated concurrently over 6 ½ weeks 
Cohort 2 
  • Pre-operative RT – 50.4 Gy in 28 daily fractions over 5½ weeks 
  • Post-operative RT - 54 Gy in 30 daily fractions over 6 weeks 
  • Primary RT - 54 Gy in 30 daily fractions over 6 weeks 
Cohort 3 
  • Primary RT – 70 Gy in 35 daily fractions over 7 week 
  • Post-operative RT (non-chordoma) – primary bone sarcoma 60 Gy in 30 daily fractions over 6 weeks 
  • Post-operative RT (chordoma) – 70 Gy in 35 daily fractions over 7 weeks 

Key inclusion/exclusion criteria: Patients with histopathological diagnosis of Soft tissue sarcoma of the upper or lower limb or limb girdle (cohort 1), or Ewing’s sarcoma of bone arising in the pelvis or spine (cohort 2), or High grade non-Ewing’s primary bone sarcoma or chordoma arising in the pelvis or spine (cohort 3) are eligible. Patients who have had previous radiotherapy to the same site are not eligible. 
Duration of recruitment: 191 patients were recruited from the UK and Ireland between March 2016 and December 2019. Patients were followed up until June 2020.
Aim
To assess the feasibility, efficacy and toxicity of IMRT in three different cohorts of patients with bone and soft tissue sarcoma and to demonstrate whether IMRT can improve on current clinical outcomes. This will be assessed by looking at:
  • the rate of grade 2 or more late soft tissue fibrosis at 2 years following RT (cohort 1)
  • the proportion of patients where ≥95% of the recommended optimal RT dose can be achieved with IMRT (cohorts 2 & 3)
Trial protocols
Trial protocols must not be applied to patients treated outside trials. UCL CTC can only ensure that approved trial investigators are provided with amendments to protocols.
No protocols have been currently made available for download
Trial documents
No documents have been currently made available for download
Contact Us
Cancer Research UK & UCL Cancer Trials Centre
University College London
90 Tottenham Court Road
London
W1T 4TJ

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Email:
ctc.enquiries@ucl.ac.uk
Telephone:
+44 (0)20 7679 9898 (General CTC Enquiries)
Fax:
020 7679 9899
University College London, Gower Street, London, WC1E 6BT +44 (0)20 7679 2000

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