A Study of IMRT in Primary Bone and Soft Tissue Sarcoma (IMRiS)
Soft Tissue Sarcoma, Adult, Ewing Sarcoma, Bone Sarcoma
About this trial
This is an interventional treatment trial for Soft Tissue Sarcoma, Adult focused on measuring Intensity Modulated Radiotherapy, Radiotherapy
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
- 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.
Sites / Locations
- St Luke's Hospital
- Clatterbridge Cancer Centre
- Belfast City Hospital
- Queen Elizabeth Hospital
- Bristol Haematology and Oncology Centre
- Adenbrookes' Hospital
- Velindre Hospital
- Cheltenham Hospital
- University Hospital Coventry
- Royal Derby Hospital
- Western General Hospital
- Royal Devon & Exeter Foundation Trust
- Beatson West of Scotland Cancer Centre
- St James' Institute of Oncology
- Leicester Royal Infirmary
- University College London Hospitals
- The Christie Hospital
- Northern Centre for Cancer Care
- Northampton General Hospital
- Norfolk and Norwich University Hospital
- Nottingham City Hospital
- Churchill Hospital
- Derriford Hospital
- Royal Preston Hospital
- Weston Park Hospital
- Southampton General Hospital
- The Royal Marsden NHS Foundation Trust
- Singleton Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Other
Other
Other
Cohort 1 (closed to recruitment)
Cohort 2
Cohort 3
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.
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.
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.