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RADIOTHERAPY CLINICAL PROTOCOL Bone Metastases

Scope: The following process has been devised to provide current guidelines for Palliative Radiotherapy to Bone Metastases (excluding Spinal Cord Compression / Cauda Equina). Consultant Clinical Oncologists, Associate Specialist Clinical Oncology, Specialist Registrars Clinical Oncology, HPC Registered Therapy Radiographers, Medical Physicists, Clinical Technologists, Medical Technical Officers to deliver all or part of the activity described. MV Mega-Voltage kV Kilovoltage SIJs Superior Iliac Joints C-Spine Cervical T-Spine Thoracic L-Spine Lumbar S-Spine Sacral MRI Magnetic Resonance Imaging Patients Healthcare Records Patients Consent Form F.TD.11 Radiotherapy Request Form Patients Treatment Card MR.PC.05 Procedure for the Production of Custom Thermoplastic Immobilisation Shells - Head & Neck TD.PC.21 Using Immobilisation Moulds PL.PC.35 Aims Of Treatment Planning RT.PT.11 Radiotherapy Clinical Protocol Brain Metastases SI.PC.46 Treatment Verification Procedure REF-7 Review Clinics' Timetable & Schedule TD.PO.03 Radiotherapy Interruptions Policy TD.PC.01 Procedures For Minimising Interruptions In Treatment And Transferring Patients Between Linear Accelerators

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Context The following protocol has been written to clarify the preparation and delivery of radiotherapy to agreed clinical protocols. It is the clinicians responsibility to action individual patients treatment as a practitioner according to IR(ME)R. For treatment of Spinal Cord compression or Cauda Equina Compression, refer to the relevant radiotherapy clinical protocol.

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Radiotherapy Department

The Royal Surrey County Hospital

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RADIOTHERAPY CLINICAL PROTOCOL Bone Metastases

Background Uncomplicated bone pain responds well to radiotherapy with response rates of 70-80%. It may take 4-6 weeks for response to be achieved, thus consideration should be given to a patients prognosis before commencing treatment. Adequate analgesia should be administered before localisation and treatment. Indications for Radiotherapy 1. 2. 3. 4. Bone metastases presenting with pain not adequately controlled by analgesia Bone metastases causing mass effect Inoperable impending / existing pathological fracture Pathological fracture following surgical fixation

High Risk of Pathological Fracture If the cortex of the bone is eroded in relation to an osteolytic metastasis in a limb, surgical stabilization should be considered to prevent fracture. Postoperative radiotherapy should then be given. Suggested X-ray parameters indicating high risk of fracture are: > 50% cortical destruction > 3cm maximum diameter 3cm axial cortical involvement Multi-focal lytic disease Metastatic Pain at several sites Wide field or hemibody irradiation can be considered in this situation. Single fraction regimens appear to offer good symptom relief with acceptable toxicity. Re-Irradiation This may be indicated for recurrent symptoms at any site and needs to be assessed individually with an assessment of previous radiation doses, response to previous irradiation (degree and length), prognosis and local radiation tissue tolerance.

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Radiotherapy Department

The Royal Surrey County Hospital

NHS Foundation Trust CONTROLLED DOCUMENT

RADIOTHERAPY CLINICAL PROTOCOL Bone Metastases

1 Palliative 1.1 Information Required Clinic notes / letter from initial consultation Drug history Details of orthopaedic intervention / opinion, where relevant Previous radiotherapy treatment card, simulator films and radiotherapy plans, where relevant Pre post-operative plain X-ray report and films Bone scan report and films Staging CT / MRI report and films, where relevant Immobilisation Head / C-Spine: may benefit from Orfit Thermoplastic Shell Extremities: may benefit from Body Vacfix Orientation, Set-up, Wax / Bolus Indicated by the treatment site with the use of adequate foam pads or pillows to optimise both patient comfort and treatment reproducibility. Head: Supine, prone for posterior lesions, head rest Spine: Prone if patient able (otherwise supine), head rest Pelvis: Supine Extremities: Treatment site to be positioned away from normal tissue Scapula: Supine unless mark-up on-set (when decuibitus or prone) Ribs: Dependent on site of rib metastasis to be treated Sternum: Supine Localisation Conventional Simulation, Virtual Simulation via CT or clinical mark-up on-set (with subsequent confirmation of localisation by simulation, if necessary). Clinical examination may aid localisation of tender areas, marked with wire for external beam or pen for orthovoltage therapy. Areas particularly amenable to mark on set Superficial scalp Scapula Ribs Sternum Rectal / Bladder Status None

1.2

1.3

1.4

1.5

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The Royal Surrey County Hospital

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RADIOTHERAPY CLINICAL PROTOCOL Bone Metastases

1.6 Target Definition The GTV = The volume of metastatic disease, as determined by diagnostic imaging and clinical examination The CTV = The GTV + surrounding bone at risk of microscopic involvement The PTV = The CTV with a margin dependent on the treatment site Field borders should cover the area of metastatic involvement (the CTV) with a 1-3cm margin while making anatomical considerations to aid future matching of fields and to avoid treatment of normal tissues. For post-operative treatment, the field should include metalwork with a 12cm margin. Field Borders: Head: For whole skull treatment, refer to Radiotherapy Clinical Protocol for Brain Metastases, Whole Brain Radiotherapy. For mark-up on-set, a 1-2cm margin on the GTV should suffice, with the field size and shape chosen using the choice of applicators available lead shielding. The affected vertebrae with 1-2 vertebrae above (superior field border) and below (inferior field border), unless matching with previous fields. The lateral field borders: 2cm lateral to vertebral body edge, or 1-2cm lateral to paravertebral extension, whichever is most lateral. Where the lower lumbar spine is treated, the sacrum may also be included in a Spade shaped field. The SIJs are included with a 1-2cm margin, for the lateral field border. For C-Spine lesions treated with a parallel opposed lateral pair, the field should include the spinous processes with a 1-2cm margin posterior to spinous process and 1-2cm anterior to the anterior aspect of the vertebral body. Pelvis: Lower pelvic fields follow anatomical division of the pelvis into quadrants, unless the field border traverses disease. For lesions involving the proximal femur, the lesser trochanter is included with a 1-2cm margin inferiorly.

Spine:

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RADIOTHERAPY CLINICAL PROTOCOL Bone Metastases

Extremities: The field should include the GTV with a 1-3cm margin in the super-inferior direction and a 1.5-2cm margin laterally. As stated above, metalwork should be covered with a 12cm margin (unless, by doing so, field length is unacceptably long). A corridor of normal tissue should remain out of the field to reduce the risk of lymphoedema. Scapula: For parallel opposed fields the arm should be abducted to minimise the volume of lung in the field. For mark-up onset, field borders are determined as above for head fields. As for mark-up on-set for head fields. Field borders include a 1-2cm margin on the GTV.

Ribs: Sternum: 1.7

Field Arrangement Head: Usually parallel opposed fields unless mark-up on-set of a skull lesion C-Spine: Where the T-Spine is not included and the patient is able to have the shoulders sufficiently caudal to be out of the field, a parallel opposed pair of lateral fields may be used to minimise mucositis. Otherwise, a single posterior field.

T/L/S Spine: A single posterior field Pelvis: A parallel opposed pair, anterior and posterior

Extremities: A parallel opposed pair, anterior and posterior Scapula: Ribs: Sternum: Either single posterior field or parallel opposed pair if the shoulder is to be included in the field Usually a single applied field A single anterior / applied field

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RADIOTHERAPY CLINICAL PROTOCOL Bone Metastases

1.8 Critical, Normal Tissue and Organ Limits In 2Gy/#, whole organ: Lens: 6Gy Whole brain: 45Gy 54Gy Brainstem: Spinal cord: 46Gy Cauda equina: 60Gy 50Gy Optic chiasm: Optic nerve: 54Gy Retina: 50Gy Cornea: 40Gy Lumbar fields consideration must be given to the width of field to minimise kidney volume in field Shielding MLC as appropriate to reduce dose to normal tissues (eg lung, eye, bowel)

1.9

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RADIOTHERAPY CLINICAL PROTOCOL Bone Metastases

1.10 Prescription, Energy and Modality Upper hemibody irradiation 6Gy/1# 8Gy/1#: Standard dose for palliation of painful bone metastases. May be used for: Inoperable impending pathological fracture Established pathological fracture Prior surgical fixation Reirradiation of bone metastases Lower hemibody irradiation 20Gy/5#: May be considered instead of single fraction for patients with a very good performance status with: Inoperable impending pathological fracture Established pathological fracture Prior surgical fixation Reirradiation of bone metastases Large field size with a significant volume of normal tissue 30Gy/10#: May be considered for patients with a good performance status and good prognosis (e.g. solitary bone metastasis from breast carcinoma) 25Gy/5#: Radiobiologically equivalent to 30Gy in 10#. May be considered for patients with a good performance status and good prognosis with a tumour with a high fraction sensitivity / low / ratio (e.g. solitary bone metastasis from renal cell or melanoma) 300kV, 6MV, 10MV or 15MV Photons For parallel opposed fields, doses are prescribed to the Mid Plane Dose (MPD). For single fields, doses are prescribed to the treatment depth of the PTV. For thoracic spinal fields this is often 5-6cm and for lumbar spinal fields 5-7cm, although the exact depth should be determined by MRI / CT images, where available. For orthovoltage therapy, doses are prescribed as an applied dose to the skin surface. Chemotherapy None Verification Verification is only required for cases immobilised with an Orfit thermoplastic shell and those who have been localised by Virtual Simulation

1.11 1.12

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RADIOTHERAPY CLINICAL PROTOCOL Bone Metastases

1.13 Specialist Referral Palliative Care Team, Rehabilitation Team, Social Workers and Dietician, as required Investigations None Review Weekly for multiple fractionations Dose Checks None Scheduled / Unscheduled Breaks As per Radiotherapy Interruptions Policy Follow Up Either clinic review 4-6weeks following completion of radiotherapy or with community based Palliative Care Team

1.14 1.15 1.16 1.17 1.18

References Amichelli M et al. Comparative Evaluation Of Two Hypofractionated Radiotherapy Regimes For Painful Bone Metastases. Tumori 2004; 90(1): 91-5 Barton R, Robinson G, Gutierrez E, Kirkbride P, McLean M. Palliative radiation for vertebral metastases: the effect of variation in prescription parameters on the dose received at depth. International Journal of Radiation Oncology, Biology, Physics 2002; 52: 1083-91 Bone Pain Trial Working Party. 8Gy Single Fraction Radiotherapy For The Treatment Of Metastatic Skeletal Pain: Randomised Comparison With A Multifraction Schedule Over 12 Months Of Patient Follow-Up. Radiother Oncol 1999; 52(2): 111-21 Chataigner H et al. Surgery In Spinal Metastasis Without Spinal Cord Compression: Indications And Strategy Related To The Risk Of Recurrence. Eur Spine J 200; 9(6): 523-527 Chow E et al. Successful Validation Of A Survival Prediction Model In Patients With Metastases In The Spinal Column. Int J Radiat Biol Phys 2006; 65(5): 1522-7 Fung KY et al. Management Of Malignant Atlanto-Axial Tumours. J Orthop Surg (Hong Kong) 2005; 13(3): 232-9
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RADIOTHERAPY CLINICAL PROTOCOL Bone Metastases

Hartsell WE et al. Randomised Trial Of Short-Versus Long-Course radiotherapy For Palliation Of Painful Bone Metastases. J Natl Cancer Inst 2005; 97(11): 798-804 Hoskin PJ et al On Behalf Of The Participants Of The Second Workshop On Palliative Radiotherapy And Symptoms Control, London 2000. Radiotherapy For Bone Metastases, Consensus Statement. Clin Oncol 2001; 13(2): 88-90 Katagiri H et al. Clinical Results Of Nonsurgical Treatment For Spinal Metastases. Int J Radiat Oncol Biol Phys 1998; 42(5): 1127-1132 McQuay HJ et al. Radiotherapy For The Palliation Of Painful Bone Metastases. Cochrane Database Syst Rev 2000; (2): CD001793 Nielson OS et al. Randomised Trial Of Single Dose Versus Fractionated Palliative Radiotherapy of Bone Metastases. Radiother Oncol 1998; 47(3): 23340 Price P et al. Prospective Randomised Trial Of Single And Multifraction Radiotherapy Schedules In The Treatment Of Painful Bony Metastases. Radiother Oncol 1986; 6(4): 247-55 The R.C.R. Board of Faculty of Clinical Oncology 'Radiotherapy Dose Fractionation' 2006 Roos DE et al. Randomised Trial Of 8Gy in 1 Fraction Versus 20Gy in 5 Fractions Of Radiotherapy For Neuropathic Pain Due To Bone Metastases (Trans-Tasman Radiation Oncology Group. TROG 96.05). Radiother Oncol 2005; 75(1): 54-63 Steenland E et al. The Effect Of A Single Fraction Compared To Multiple Fractions On Painful Bone Metastases: A Global Analysis Of The Dutch Bone Metastasis Study. Radioth Oncol 1999; 52(2): 101-9 Sundaresan N et al. Surgery For Solitary Metastases Of The Spine. Rationale And Results Of Treatment. Spine 2002; 27: 1802-06 Sze WM et al. Palliation Of Metastatic Bone Pain: Single Fraction Versus Multifraction Radiotherapy-A Systematic Review Of Randomised Trials. Clin Onc 2003; 15(6): 345-52 Van den Hout WB et al. Single-Versus Multiple Fraction Radiotherapy In Patients With Painful Bone Metastases: Cost-Utility Analysis Based On A Randomised Trial. J Natl Cancer Inst 2003; 95(3): 222-9

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Van der Linden YM et al. Patients With A Favourable Prognosis Are Equally Palliated With Single And Multiple Fraction Radiotherapy: Results On Survival In The Dutch Bone Metastasis Study. Radiother Oncol 2006; 78(3): 245-53 Van der Linden YM et al. Prediction Of Survival In Patients With Metastases In The Spinal Column: Results Based On A Randomised Trial Of Radiotherapy. Cancer 2005; 103(2): 320-8 Wai MS et al. Palliation of Metastatic Bone Pain: Single Fraction Versus Multifraction Radiotherapy-A Systematic Review Of The Randomised Trials. Cochrane Database Syst Rev 2004; (2): CD004721 Wong CS et al. Radiation Myelopathy Following Single Courses Of Radiotherapy And Retreatment. Int J Radiat Oncol Biol Phys 1994; 30(3): 575581 Wu JS et al. Meta-Analysis Of Dose-Fractionation Radiotherapy Trials For The Palliation Of Painful Bone Metastases. Int J Radiat Oncol Biol Phys 2003; 55(3): 594-605 Young RF et al. Treatment Of Spinal Epidural Metastases. Randomized Prospective Comparison Of Laminectomy And Radiotherapy. J Neurosurg 1980; 53(6): 741-748

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