A Study of IMRT in Primary Bone and Soft Tissue Sarcoma
IMRiS
A Phase II Study of Intensity Modulated Radiotherapy (IMRT) for Patients With Primary Bone and Soft Tissue Sarcoma
2 other identifiers
interventional
191
2 countries
28
Brief Summary
IMRiS is a phase II trial which aims to assess the feasibility, efficacy and toxicity of Intensity Modulated Radiotherapy (IMRT) in three different cohorts of patients with primary bone and soft tissue sarcoma and to demonstrate whether IMRT can improve on current clinical outcomes. Cohort 1 of the trial is now closed to recruitment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2016
Longer than P75 for not_applicable
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 31, 2015
CompletedFirst Posted
Study publicly available on registry
August 11, 2015
CompletedStudy Start
First participant enrolled
March 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2020
CompletedDecember 2, 2020
December 1, 2020
4.3 years
July 31, 2015
December 1, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Cohort 1 (limb soft tissue sarcomas): The rate of grade 2 or more late soft tissue fibrosis at 2 years following radiotherapy as assessed by RTOG late radiation morbidity criteria.
Late toxicity assessment measured using RTOG late radiation morbidity criteria.
From date of registration until 2 years after date of registration.
Cohorts 2 (Ewing's sarcoma of the spine/pelvis): The proportion of patients in whom 90% of the planPTV receives 95% of the optimal prescription dose.
Cohorts 2 (Ewing's sarcoma of the spine/pelvis): The proportion of patients in whom 90% of the planPTV receives 95% of the optimal prescription dose.
Upon completion of IMRT treatment
Cohort 3 (Non-Ewing's primary bone sarcomas of the spine/pelvis): The proportion of patients in whom 80% of the planPTV receives 95% of the optimal prescription dose.
Cohort 3 (Non-Ewing's primary bone sarcomas of the spine/pelvis): The proportion of patients in whom 80% of the planPTV receives 95% of the optimal prescription dose.
Upon completion of IMRT treatment
Secondary Outcomes (12)
Acute RT toxicity - (For all cohorts)
From date of registration up to 90 days after date of registration
Late RT toxicity - (For all cohorts)
From Day 91 after date of registration up to 3 years after date of registration
Patient reported Quality of life (QOL) - (All cohorts)
Timepoints- Baseline, 1 year and 2 year post treatment
Patient reported limb function (Cohort 1 only)
At timepoints - Baseline, 1 year and 2 years post Treatment
Disease free survival (All Cohorts)
The start date for analysis will be the date of registration. From date of registration to date of documented disease progression assessed up to 3 years from date of registration
- +7 more secondary outcomes
Study Arms (3)
Cohort 1 (closed to recruitment)
OTHERCohort 1: Patients with Limb/limb girdle soft tissue sarcoma (STS) receiving (neo)-adjuvant radiotherapy (Intensity Modulated Radiotherapy) Dose schedules for 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
OTHERCohort 2: Patients with Ewing sarcoma of the spine/pelvis receiving definitive radical or (neo)-adjuvant radiotherapy (Intensity Modulated Radiotherapy) Dose schedules for 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
OTHERCohort 3: Patients with non-Ewing primary bone sarcomas of the spine/pelvis receiving definitive radical or adjuvant Radiotherapy (Intensity Modulated Radiotherapy) Dose schedule for 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.
Interventions
Intensity modulated radiotherapy (IMRT) is an advanced radiotherapy technique that is able to deliver a highly conformal dose to a target with improved sparing of the surrounding normal tissues from moderate to high radiation doses. IMRT is likely to be of particular benefit for tumours that have complex shapes, or those in close proximity to sensitive normal tissues and critical organs. Reducing the dose to normal tissues may in turn reduce the acute and late side effects of treatment. IMRT can be delivered from multiple fixed beam angles or through rotational arc applications such as volumetric modulated arc therapy (VMAT) and tomotherapy. The radiotherapy is delivered using multiple small beams (beamlets) of non-uniform intensity.
Eligibility Criteria
You may qualify if:
- Histologically proven soft tissue sarcoma of the upper or lower limb or limb girdle (Cohort 1), OR,
- Ewing sarcoma of bone arising in the pelvis or spine (Cohort 2) , OR,
- High grade primary bone sarcoma (non-Ewing) or Chordoma arising in the pelvis/spine (Cohort 3)
- Patients requiring (neo)adjuvant or definitive radical radiotherapy
- WHO performance status 0-2
- Patients aged 16 years or more
- Patients fit enough to undergo radiotherapy treatment and willing to attend follow up visits as per protocol
- Women of child-bearing potential must have a negative pregnancy test prior to trial entry. Female patients of child-bearing potential and male patients with partners of child-bearing potential must agree to use adequate contraception methods, which must be continued for 3 months after completion of treatment.
- Capable of giving written informed consent
You may not qualify if:
- Previous radiotherapy to the same site
- Patients receiving concurrent chemotherapy with radiotherapy (neo-adjuvant chemotherapy prior to radiotherapy is permitted.
- Patient with bone sarcomas eligible for proton beam radiotherapy; N.B. if a patient is not to have PBRT for whatever reason, they may be considered for IMRiS.
- Paediatric type alveolar or embryonal rhabdomyosarcomas
- Pregnancy (Women of child-bearing potential must have a negative pregnancy test prior to trial entry. Female patients of child-bearing potential and male patients with partners of child-bearing potential must agree to use adequate contraception methods, which must be continued for 3 months after completion of treatment
- Patients with concurrent or previous malignancy that could compromise assessment of the primary and secondary endpoints of the trial; these cases must be discussed with UCL CTC prior to the patient being approached.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University College, Londonlead
- Cancer Research UKcollaborator
- NCRI Radiotherapy Trials QA (RTTQA) Groupcollaborator
Study Sites (28)
St Luke's Hospital
Dublin, Ireland
Clatterbridge Cancer Centre
Bebington, United Kingdom
Belfast City Hospital
Belfast, United Kingdom
Queen Elizabeth Hospital
Birmingham, United Kingdom
Bristol Haematology and Oncology Centre
Bristol, United Kingdom
Adenbrookes' Hospital
Cambridge, United Kingdom
Velindre Hospital
Cardiff, CF5 6SH, United Kingdom
Cheltenham Hospital
Cheltenham, United Kingdom
University Hospital Coventry
Coventry, United Kingdom
Royal Derby Hospital
Derby, DE22 3NE, United Kingdom
Western General Hospital
Edinburgh, United Kingdom
Royal Devon & Exeter Foundation Trust
Exeter, EX2 5DW, United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, G12 0YN, United Kingdom
St James' Institute of Oncology
Leeds, United Kingdom
Leicester Royal Infirmary
Leicester, United Kingdom
University College London Hospitals
London, NW1 2PG, United Kingdom
The Christie Hospital
Manchester, United Kingdom
Northern Centre for Cancer Care
Newcastle, United Kingdom
Northampton General Hospital
Northampton, United Kingdom
Norfolk and Norwich University Hospital
Norwich, NR4 7UY, United Kingdom
Nottingham City Hospital
Nottingham, United Kingdom
Churchill Hospital
Oxford, United Kingdom
Derriford Hospital
Plymouth, United Kingdom
Royal Preston Hospital
Preston, United Kingdom
Weston Park Hospital
Sheffield, S10 2SJ, United Kingdom
Southampton General Hospital
Southampton, SO16 6YD, United Kingdom
The Royal Marsden NHS Foundation Trust
Sutton, United Kingdom
Singleton Hospital
Swansea, United Kingdom
Related Publications (2)
Simoes R, Gulliford S, Seddon B, Dehbi HM, Robinson M, Forsyth S, Hughes A, Gaunt P, Nguyen TG, Elston S, Mohammed K, Zaidi S, Miles E, Hoskin P, Harrington K, Miah A. Predicting radiotherapy response, Toxicities and quality-of-life related functional outcomes in soft tissue sarcoma of the extremities (PredicT) using dose-volume constraints development: a study protocol. BMJ Open. 2024 Aug 9;14(8):e083617. doi: 10.1136/bmjopen-2023-083617.
PMID: 39122389DERIVEDSimoes R, Miles E, Yang H, Le Grange F, Bhat R, Forsyth S, Seddon B. IMRiS phase II study of IMRT in limb sarcomas: Results of the pre-trial QA facility questionnaire and workshop. Radiography (Lond). 2020 Feb;26(1):71-75. doi: 10.1016/j.radi.2019.08.006. Epub 2019 Sep 14.
PMID: 31902458DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Beatrice Seddon, Ph.D., M.D
University College London Hospitals
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 31, 2015
First Posted
August 11, 2015
Study Start
March 1, 2016
Primary Completion
June 30, 2020
Study Completion
June 30, 2020
Last Updated
December 2, 2020
Record last verified: 2020-12