A Study of IMRT in Primary Bone and Soft Tissue Sarcoma
NCT ID: NCT02520128
Last Updated: 2020-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
191 participants
INTERVENTIONAL
2016-03-31
2020-06-30
Brief Summary
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Cohort 1 of the trial is now closed to recruitment.
Detailed Description
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Cohort 1- Patients with Limb/limb girdle soft tissue sarcoma receiving (neo)-adjuvant radiotherapy. (closed to recruitment)
Cohort 2- Patients with Ewing sarcoma of the spine/pelvis receiving definitive radical or (neo)-adjuvant radiotherapy.
Cohort 3- Patients with non-Ewing primary bone sarcomas of the spine/pelvis receiving definitive radical or adjuvant radiotherapy.
Dose schedules for each Cohort have been indicated in the Trial Arm description.
Radiotherapy will be delivered with fixed beam IMRT, arc IMRT techniques, or tomotherapy. All trial patients will be followed up until death or a maximum of three years from the date of registration in the trial.
The theoretical advantage to IMRT is the potential reduction in late toxicity and subsequent potential for functional improvement. There have been no prospective studies to date powered to address this, particularly where IMRT is used post-operatively. IMRiS cohort 1 will address this question and establish if the use of IMRT will reduce late normal tissue toxicity.
In cohorts 2 \& 3, the aim is to establish if the use of IMRT will enable the achievement of a radiotherapy treatment plan that delivers the optimal dose while keeping within normal tissue tolerances. There have been no clinical trials of IMRT in Ewing sarcoma and there is very little published on the use of IMRT in high grade bone sarcomas and chordomas. It is important to establish the feasibility of IMRT to achieve the required radiation doses to the tumour, and to prospectively document the side effects of treatment in this setting. IMRiS will address this in cohort 2 and cohort 3.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Cohort 1 (closed to recruitment)
Cohort 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.
Intensity modulated radiotherapy (IMRT)
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.
Cohort 2
Cohort 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.
Intensity modulated radiotherapy (IMRT)
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.
Cohort 3
Cohort 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.
Intensity modulated radiotherapy (IMRT)
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.
Interventions
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Intensity modulated radiotherapy (IMRT)
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
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Inclusion Criteria
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)
2. Patients requiring (neo)adjuvant or definitive radical radiotherapy
3. WHO performance status 0-2
4. Patients aged 16 years or more
5. Patients fit enough to undergo radiotherapy treatment and willing to attend follow up visits as per protocol
6. 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.
7. Capable of giving written informed consent
Exclusion Criteria
2. Patients receiving concurrent chemotherapy with radiotherapy (neo-adjuvant chemotherapy prior to radiotherapy is permitted.
3. 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.
4. Paediatric type alveolar or embryonal rhabdomyosarcomas
5. 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
6. 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.
16 Years
ALL
No
Sponsors
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Cancer Research UK
OTHER
NCRI Radiotherapy Trials QA (RTTQA) Group
UNKNOWN
University College, London
OTHER
Responsible Party
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Principal Investigators
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Beatrice Seddon, Ph.D., M.D
Role: PRINCIPAL_INVESTIGATOR
University College London Hospitals
Locations
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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, , United Kingdom
Cheltenham Hospital
Cheltenham, , United Kingdom
University Hospital Coventry
Coventry, , United Kingdom
Royal Derby Hospital
Derby, , United Kingdom
Western General Hospital
Edinburgh, , United Kingdom
Royal Devon & Exeter Foundation Trust
Exeter, , United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, , United Kingdom
St James' Institute of Oncology
Leeds, , United Kingdom
Leicester Royal Infirmary
Leicester, , United Kingdom
University College London Hospitals
London, , 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, , 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, , United Kingdom
Southampton General Hospital
Southampton, , United Kingdom
The Royal Marsden NHS Foundation Trust
Sutton, , United Kingdom
Singleton Hospital
Swansea, , United Kingdom
Countries
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References
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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.
Simoes 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.
Other Identifiers
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C2921/A17558
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
UCL/13/0376
Identifier Type: -
Identifier Source: org_study_id