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Soft Tissue Sarcoma, AdultIMRiSNCT02520128

A Study of IMRT in Primary Bone and Soft Tissue Sarcoma

A study testing Intensity modulated radiotherapy (IMRT) in people with Soft Tissue Sarcoma, Adult and Ewing Sarcoma, run by University College, London at 28 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 16 years and older
What is being tested?
Intensity modulated radiotherapy (IMRT)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
191 participants
Where
28 sitesin 2 countries
Study dates
Mar 2016to 30 Jun 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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.

Trial locations and contacts

28 sites in 2 countries.

28 sites in 2 countries

United Kingdom27 sites

  • Clatterbridge Cancer Centre

    Bebington

  • Belfast City Hospital

    Belfast

  • Queen Elizabeth Hospital

    Birmingham

  • Bristol Haematology and Oncology Centre

    Bristol

  • Adenbrookes' Hospital

    Cambridge

  • Velindre Hospital

    Cardiff, CF5 6SH

  • Cheltenham Hospital

    Cheltenham

  • University Hospital Coventry

    Coventry

  • Royal Derby Hospital

    Derby, DE22 3NE

  • Western General Hospital

    Edinburgh

  • Royal Devon & Exeter Foundation Trust

    Exeter, EX2 5DW

  • Beatson West of Scotland Cancer Centre

    Glasgow, G12 0YN

  • St James' Institute of Oncology

    Leeds

  • Leicester Royal Infirmary

    Leicester

  • University College London Hospitals

    London, NW1 2PG

  • The Christie Hospital

    Manchester

  • Northern Centre for Cancer Care

    Newcastle

  • Northampton General Hospital

    Northampton

  • Norfolk and Norwich University Hospital

    Norwich, NR4 7UY

  • Nottingham City Hospital

    Nottingham

  • Churchill Hospital

    Oxford

  • Derriford Hospital

    Plymouth

  • Royal Preston Hospital

    Preston

  • Weston Park Hospital

    Sheffield, S10 2SJ

  • Southampton General Hospital

    Southampton, SO16 6YD

  • The Royal Marsden NHS Foundation Trust

    Sutton

  • Singleton Hospital

    Swansea

Other trials in United Kingdom

Ireland1 site

  • St Luke's Hospital

    Dublin

Other trials in Ireland

About this study

Official title: A Phase II Study of Intensity Modulated Radiotherapy (IMRT) for Patients With Primary Bone and Soft Tissue Sarcoma

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.

Read the detailed description

IMRiS is a prospective multicentre phase II trial of Intensity Modulated Radiotherapy (IMRT). The trial is aiming to evaluate the role of intensity modulated radiotherapy (IMRT) in soft tissue and bone sarcomas. Three separate sarcoma cohorts will be studied and will be analysed separately. Patients will be enrolled in one of three cohorts depending on the type of sarcoma they have:

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.

Being tested
Intensity modulated radiotherapy (IMRT)
Keywords
Intensity Modulated Radiotherapy, Radiotherapy
Medical subject headings
Sarcoma, Sarcoma, Ewing, Bone Neoplasms, Chordoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intensity modulated radiotherapy (IMRT)Radiation

    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.

Study groups in NCT02520128
Study groupRoleWhat they receive
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.
Receives: Radiation: Intensity modulated radiotherapy (IMRT)
Cohort 2OtherCohort 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.
Receives: Radiation: Intensity modulated radiotherapy (IMRT)
Cohort 3OtherCohort 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.
Receives: Radiation: Intensity modulated radiotherapy (IMRT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From date of registration until 2 years after date of registration.

  2. 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.

    Measured: Upon completion of IMRT treatment

  3. 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.

    Measured: Upon completion of IMRT treatment

Secondary outcomes (12)

  1. Acute RT toxicity - (For all cohorts)

    In all 3 cohorts, Acute RT toxicity measured using RTOG acute radiation morbidity criteria.

    Measured: From date of registration up to 90 days after date of registration

  2. Late RT toxicity - (For all cohorts)

    In all 3 cohorts, late toxicities measured using the RTOG/EORTC Late Radiation Morbidity Scoring Criteria (skin, subcutaneous tissue fibrosis, bone, joint stiffness) and Stern's scale for oedema

    Measured: From Day 91 after date of registration up to 3 years after date of registration

  3. Patient reported Quality of life (QOL) - (All cohorts)

    All cohorts, patient reported Quality of life measured using EORTC QLQ-C30 quality of life questionnaire

    Measured: Timepoints- Baseline, 1 year and 2 year post treatment

  4. Patient reported limb function (Cohort 1 only)

    For patients in Cohort 1 only, patient reported limb function measured using TESS questionnaire

    Measured: At timepoints - Baseline, 1 year and 2 years post Treatment

  5. Disease free survival (All Cohorts)

    Disease free survival will be calculated from the date of registration to date of documented disease progression, or death from any cause. Where progression is suspected and subsequently confirmed by scans, the date of documented suspected progression will be used. Patients alive and disease-free will be censored at the date last seen.

    Measured: 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

  6. Overall survival (All Cohorts)

    Overall survival time will be calculated from date of registration to the date of death from any cause or end of trial follow up

    Measured: From date of registration to date of death or date of last follow-up assessment (assessed up to 3 years from date of registration)

  7. Time to local tumour recurrence (All Cohorts, for adjuvant RT)

    Time to local tumour recurrence evaluation from date of registration to first diagnosis of recurrence (histological or radiological).

    Measured: From date of registration to date of documented recurrence within the irradiated site (assessed up to 3 years from date of registration)

  8. Time to local disease progression (Cohorts 2 and 3, for definitive radical RT)

    Time to local disease progression evaluation from date of registration to first diagnosis of progression.

    Measured: From date of registration to date of documented progression (assessed up to 3 years from date of registration)

  9. Response by RECIST 1.1 (Cohorts 2 and 3, for definitive radical RT)

    Response measured according to RECIST v 1.1 (for definitive radical RT)

    Measured: From date of registration to date of documented progression (assessed up to 3 years from date of registration)

  10. Wound complications within 120 days of surgery (Cohort 1 only)

    Rate and severity of wound complications assessed up to 120 days post surgery. This is a composite outcome measure assessed by a clinical examination of the wound.

    Measured: From date of definitive surgery until 120 days post surgery

  11. For individual plans (cohort 2 & 3)

    Percentage volume of planPTV receiving 95% of the prescription dose (50.4Gy/54Gy for cohort 2 and 60Gy/70Gy for cohort 3)

    Measured: Upon completion of IMRT treatment.

  12. For individual plans (cohort 2 & 3)

    Dose delivered to 95%, 80%, 70%, 60% and 50% volume of planPTV.

    Measured: Upon completion of IMRT treatment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Aug 2015 (estimated)
  2. Study startMar 2016
  3. Primary completion30 Jun 2020
  4. Study completion30 Jun 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
191 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02520128
Sponsor's protocol ID
UCL/13/0376
Other IDs
C2921/A17558
Acronym
IMRiS
Status last verified
Dec 2020
First submitted
31 Jul 2015
Last updated
2 Dec 2020
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 39122389

  • 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.

    PubMed 31902458

Questions about this trial

What is this clinical trial studying?

A study testing Intensity modulated radiotherapy (IMRT) in people with Soft Tissue Sarcoma, Adult and Ewing Sarcoma, run by University College, London at 28 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in United Kingdom, Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: From date of registration until 2 years after date of registration.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02520128, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2020.

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