Radiotherapy Protocols Cranial Irradiation for Palliative Whole Brain for Metastases and Prophylactic Whole Brain for SCLC Prepared by: Dr C Blesing, Dr N Warner, Dr D Cutter, Ms R Watson, Ms L Drummond, Mr W Fenwick, Neuro-Oncology MDT with contribution from Dr N. Panakis, Lung Oncologist. PRIMARY OBJECTIVE AND SCOPE: This combined document is intended to summarise the rationale, planning and treatment of patients receiving palliative whole brain radiotherapy for metastases and prophylactic cranial irradiation. Responsibilities for the process are described within CD-L2-001 For patients requiring whole CNS treatment see CD-L3-002. For stereotactic cranial radiotherapy for brain metastases see CD-L3-018. For palliative cranial radiotherapy for primary brain tumours see CD-L3-019. Index Section Page 1 Indications 1 2 Pre-Radiotherapy Investigations 2 3 Therapeutic Schema 2-3 4 Pre-Treatment 4-5 5 Treatment 6 6 Follow Up 6 7 Linked Documentation And Abbreviations & Acronyms Appendix 1 Karnofsky Performance Status Scale 8 Appendix 2 Document Development Checklist 9-10 7 TVCN WBRT and PCI Version 1 Issue date: 12.1.2015 Page 1 of 10
1. INDICATIONS Brain Metastases RTOG Recursive Partitioning Analysis (RPA) for Median Survival brain metastases Class I KPS >=70, <65 years, controlled primary, no 7.1 months. extra-cranial metastases. Class II Neither I nor III 4.2 months Class III KPS <70. 2.3 months Good prognosis patients: Patients following resection of limited brain metastases or stereotactic radiosurgery with no evidence of progressive systemic disease RPA class 1 and some class II. Following resection of 1 to 3 isolated brain metastases, there is no evidence of survival benefit (median survival 10 months) from adjuvant cranial RT, however there is a delay in neurological progression of 1.2 months (from 3.4 to 4.6 months) (EORTC 22952 Kocher 2011) Stereotactic radiotherapy/radiosurgery should be considered for good prognosis patients. Patients should be referred to the Neuro-oncology MDT for consideration of SRT/SRS but must fit into the criteria described in CD-L3-018, Section 3F. Poor prognosis patients: all other patients (consider age, PS and neurological deficit). All RPA class III and some class II. Acute Lymphoblastic Leukaemia (A.L.L) (Including Prophylactic Cranial Irradiation) Patients with CNS disease at presentation. Patients with an isolated CNS relapse on or off treatment who have not previously received radiotherapy. Testicular involvement at presentation. or Follow relevant clinical trial protocol. If CSF+ disease, patient to receive Whole CNS treatment following CD-L3-002. Prophylactic Cranial Irradiation for Small Cell Lung Cancer (SCLC) Patients with a Performance status of 0-2 who have no evidence of progressive disease should be offered PCI no later than 6 weeks after the final cycle of chemotherapy. PCI reduces the incidence of cerebral metastases from 58% to 33% at 2 years and improves overall survival at 3 years from 15% to 21% in patients with limited stage SCLC with a good partial or complete response to induction chemotherapy. In extensive stage SCLC, PCI reduces the incidence of symptomatic brain metastases from 40% to 15%. There is also an improvement in 1 year survival from 13% to 27%. Patients with a history of cerebrovascular disease should be offered PCI at clinician s discretion TVCN WBRT and PCI Version 1 Issue date:12.1.2015 Page 2 of 10
2. PRE-RADIOTHERAPY INVESTIGATIONS For consideration of radiotherapy, patients must have metastases proven by biopsy or radiologically confirmed if known primary tumour. If isolated metastases (1, 2 or occasionally 3) on MRI and NO progressive systemic disease, consider referral for neurosurgical resection or stereotactic radiotherapy. Therefore investigate as appropriate. 3. THERAPEUTIC SCHEMA: Palliative Cranial Radiotherapy Prescription, Prescription Point and Target Definition Brain Metastases - Good prognosis Whole Brain Radiotherapy (WBRT) 30Gy in 10 x 3Gy fractions x5/week MPD +/- Conformal Boost 12-15Gy in 5 x2.4gy to 3Gy fractions x5/week CTV = whole brain Field Margin = CTV + 1.0cm (include scalp in margin) Brain Metastases - Poor prognosis WBRT 20Gy in 5 x4gy fractions x5/week MPD CTV = whole brain Field Margin = CTV + 1.0cm (include scalp in margin) A.L.L (CNS disease or PCI) 24Gy in 12 x 2Gy fractions x5/week CTV = Whole Brain (including optic nerves) PTV = CTV + 0.5cm PCI for SCLC 25Gy in 10 x2.5gy fractions x5/week is prescribed to the 100% isodose TVCN WBRT and PCI Version 1 Issue date:12.1.2015 Page 3 of 10
4. PRE TREATMENT Mould Room OXFORD CANCER CENTRE Patients are positioned using a thermoplastic immobilisation shell. See OCC-MR-L2-001. The majority of patients should be positioned supine with neck fully flexed. For further guidance see OCC-PT-L4-008 Guidelines for Head and Neck Immobilisation. Thermoplastic shells are manufactured following MR Tutorial 13 by appropriately experienced mould room staff and set up position documented on OCC-PT-L4-007c. CT Planning Scan The planning CT will be conducted in the RT department following OCC-PT-L2-001. IV contrast is not routinely used for palliative cranial planning. This may be specifically requested on the planning request form (RT 4.4). There is no need to place ExacTrac CT markers on palliative cranial patients. Virtual CT simulation is used for all palliative cranial patients. Conventional simulation may be used for whole brain RT if CT is unavailable. Method 1. Prepare the couch with the relevant fixation board as specified on the information from mould room. 2. Explain the procedure to the patient so that they are fully aware of the procedure. 3. Position the patient on the CT couch following the information provided by mould room. Fit immobilisation shell, including an appropriate number of shims to ensure a good fit and document number of shims on set-up sheet (OCC-PT-L4-007c) 4. Using the LAP laser system ensure that the patient is straight, including the central ridge on the kneefix. 5. Use LAP laser system to mark Midline using white tape and black pen except where the shell is solid, then mark directly onto the thermoplastic. 6. Move the couch into the scanner until the LAP lasers are projected longitudinally over the region of interest or suitably stable point. Mark the intersection of the lasers both anteriorly and laterally using white tape (or directly onto the shell if the lasers project onto solid thermoplastic) and black pen. The anterior and lateral intersection points represent the anterior and lateral reference points. 7. Mark the horizontal and lateral laser lines with white tape and black pen on both sides of the shell. 8. Place radio-opaque markers on the anterior and lateral reference marks. 9. Ensure the lasers run through midplane of the patient in the area to be scanned. 10. Zero the couch to the LAP lasers. 11. Scan the whole head and neck using the appropriate CT scanner programme, following guidance from OCC-PT-L4-006 12. Ensure set-up details are entered and checked in ARIA. 13. Notes to Virtual Sim to await planning. TVCN WBRT and PCI Version 1 Issue date:12.1.2015 Page 4 of 10
See OCC-PT-L3-001 Palliative Treatment Planning for guidance on Virtual Simulation or planning on the Acuity Simulator. Image Import and Registration The consultant may occasionally request diagnostic MRI images to be fused to aid palliative cranial radiotherapy planning. If there are multiple image data-sets required for treatment planning, import images as follows: 1. Primary data set CT Simulation. 2. Diagnostic MRI imaging for target delineation (named first by modality then by date e.g., MRgad_Jun09). MRI-CT fusion Diagnostic MRI images will be registered to the planning CT scan following OCC-RT-L3-010. The treating consultant shall review and approve the co-registration. Shielding Care should be taken to avoid the lenses of both eyes. Normal Tissues to be outlined None Usual field arrangement Whole Brain or part brain opposed fields. Treatment modality and energy 6MV Photons Data Entry Performed prior to patient s first attendance following OCC-RT-L2-012 TVCN WBRT and PCI Version 1 Issue date:12.1.2015 Page 5 of 10
5. TREATMENT Scheduling and Review on Treatment OXFORD CANCER CENTRE All palliative cranial patients are treated as category 3. On treatment review by clinician or Palliative Advanced Practitioner radiographer following routine review schedule or as per external protocol. For PCI for SCLC patients, treatment is given sequentially after concomitant chemo/rt to the thorax within 6 weeks of their final cycle of chemotherapy. It can be given at the same time as consolidation thoracic RT in those treated with sequential chemotherapy and thoracic radiotherapy. No need for an end of treatment review if having PCI alone. Treatment Verification and Delivery Refer to the departmental verification imaging policies (see OCC-VI-L2-001 and OCC-VI- L3-001) PREPARATION The patient should remove bulky top clothing; a thin t-shirt type layer is acceptable provided there is no bunching around the neck. Prepare the treatment couch, including any immobilisation devices, as instructed on the in-room monitor. If the accessory tray is required, attach the accessory mount to the linear accelerator. Standard treatment is using parallel opposed Left and Right Lateral fields Treatment will be delivered following OCC-RT-L2-001 Delivery of External Beam Radiotherapy after the patient has been correctly identified following OCC-RT-L3-019 External Beam Radiotherapy Patient Identification Procedure METHOD 1. Fit the patient s immobilisation shell as indicated on the in-room monitor. 2. Align reference marks and make movements to the isocentre using set up instructions. 3. Rotate gantry to position of first beam. 4. The separation must be confirmed on the first day by checking the F.S.D. 5. Position InViDos diodes (if required) according to OCC-RT-L2-003 6. Verification Imaging must be taken in line with OCC-VI-L2-001 and OCC-VI-L3-001 7. Treatment is delivered following OCC-RT-L2-001 8. Treat the remaining lateral field by repeating steps 3 to 7 Tolerances and Problems If the shell fits badly, after hair loss or reduction in swelling, an adjustment to the original shell may be required. In either case a new CT plan may be required. Guidance should be sought from a Team Leader or Palliative Advanced Practitioner radiographer. 6. FOLLOW UP Patients will be followed up at primary diagnosis outpatient clinic at their local regional hospital. Timeframe and follow up imaging specified by consultant. TVCN WBRT and PCI Version 1 Issue date:12.1.2015 Page 6 of 10
7. LINKED DOCUMENTATION CD-L2-001 CD-L3-002 CD-L3-018 CD-L3-019 OCC-CL-L2-001 OCC-CL-L2-003 OCC-MR-L2-001 OCC-PT-L2-001 OCC-PT-L2-002 OCC-PT-L3-001 OCC-PT-L4-006 OCC-PT-L4-007c OCC-PT-L4-008 OCC-RT-L2-001 OCC-RT-L2-003 OCC-RT-L2-012 OCC-RT-L3-010 OCC-RT-L3-019 OCC-VI-L2-001 OCC-VI-L3-001 MR Tutorial 13 Pregnancy Policy RT 4.4 OXFORD CANCER CENTRE Responsibilities for the Patient Pathway for Combined Disease Site Specific Protocols Whole CNS Combined Protocol Stereotactic Cranial Irradiation Protocol Primary Cranial Tumours Justification for Exposures Related to Therapeutic Radiation Patient consent Mould Room Process Planning of External Beam radiotherapy CT Scanner Planning Radiotherapy Acuity Simulator Palliative Treatment Planning Radical Planning Scan Head and Neck/ Brain Set-Up Information S frame and Laminate board Guidelines for Head and Neck Immobilisation Delivery of External Beam Radiotherapy Use of In-Vivo Dosimetry Data Procedure for Linear Accelerator Treatments Radiotherapy Image Fusion Work Instruction Patient Identification Procedure Operator Led, Practitioner Directed Verification Imaging Verification Imaging Tolerances and Frequency of Imaging Making a Zentec Thermoplastic Shell Radiotherapy Planning Request form ABBREVIATIONS AND ACRONYMS cm centimetre CSF Cerebro Spinal Fluid CNS Central Nervous System CT Computed Tomography CTV Clinical Target Volume FSD Focus Skin Distance Gy Gray IV Intra Venous KPS Karnofsky Performance Status LAP Laser Anatomical Positioning MDT Multi-disciplinary Team MRI Magnetic Resonance Imaging MV Megavoltage OUH Oxford University Hospitals PCI Prophylactic Cranial Irradiation PS Performance Status RPA Recursive Partitioning Analysis RT Radiotherapy SCLC Small Cell Lung Cancer SRT/SRS Stereotactic Radiotherapy/ Stereotactic Radiosurgery WBRT Whole Brain Radiotherapy < less than > greater than TVCN WBRT and PCI Version 1 Issue date:12.1.2015 Page 7 of 10
Appendix 1 Karnofsky Performance Status Scale 100 Normal, no complaints, no evidence of disease 90 Able to carry on normal activity, minor signs or symptoms of disease 80 Normal activity 3with effort, some signs or symptoms of disease 70 Cares for self. Unable to carry on normal activity or to do most active work 60 Requires occasional assistance, but is able to care for most of his needs 50 Requires considerable assistance and frequent medical care 40 Disabled, requires special care and assistance 30 Severely disabled, hospitalisation is indicated although death not imminent 20 Hospitalisation necessary, very sick, active supportive treatment necessary 10 Moribund, fatal processes progressing rapidly 0 Dead. TVCN WBRT and PCI Version 1 Issue date:12.1.2015 Page 8 of 10
Appendix 2: Document Development Checklist This checklist is to accompany all newly written or reviewed clinical procedural documents. In order to enable approval, the following criterion is considered to ensure compliance with set standards for document development. Should some elements not be fulfilled, the document author may be asked to make necessary changes prior to resubmission for approval. Title of Document Being Reviewed: Radiotherapy Protocol: Cranial Irradiation for Palliative WBRT for mets and Prophylactic WBRT for SCLC Policy reference Number: CD-L3-021 Is the document title clear and unambiguous? Is the document correctly and consistently defined as a Policy, Procedure, Protocol, Guideline or Strategy? Rationale Are the reasons for the development of the document stated? Document Development Process Has the document been developed using the style and format of the approved template? Do all pages have appropriate branding and header and footer content? Have contributors to the development of the document been identified? Is there evidence that relevant expertise has been used in developing the document? Have links to national guidance and/or CQC Standards been identified? If the document relates to or has implications for medications, has advice and approval be sought from the relevant medicines committee? Evidence Is there evidence to support the development of the document? Have all references been cited? Are links to other associated OUH procedural documents or information sources included? Content Are definitions of terms used, including abbreviations and acronyms, provided? Is the document clearly and concisely written? Has the target audience been defined? Have the relevant responsibilities been described? Dissemination and Implementation Does the document include an implementation plan? /No/ or Not Applicable Consistent with RT Dept quality system documentation within linked documentation TVCN WBRT and PCI Version 1 Issue date:12.1.2015 Page 9 of 10
Are there processes detailed for monitoring the implementation and effectiveness? Have any training needs been identified and planned for? Additional Information Is the Equality Assessment completed and included in the appendices? Has the Version Control been completed? Does the document have a date of issue? Does the document have a review date? Is the review date considered appropriate? Approval & Responsibility Does the document clearly state the author(s) by role/position and not name? Does the document identify the relevant committee or group who will approve it? Is the lead Director correctly identified? Comments Clinical Policy Group or Delegated Group for Approval: If the Clinical Policy Group (CPG) or delegated group for approval is happy to recommend this document for ratification, enter group details below. The Document will then be forwarded to the relevant committee for final ratification prior to publication. Name of Committee: Locally approved document (see page 1) Date of Meeting: Final Committee Ratification Name of Committee: Date of Meeting: Once this checklist is completed, please return it electronically in Word or.doc format to the Clinical Governance Unit using the email policies@ouh.nhs.uk This checklist should accompany the document awaiting approval and be included in appendices. Once the submitted document has received full approval and ratification, the Clinical Governance Unit will subsequently ensure publication via the OUH intranet Clinical Procedural Document Checklist Jan 2014 Version 2.0 TVCN WBRT and PCI Version 1 Issue date:12.1.2015 Page 10 of 10