TRANS-TASMAN RADIATION ONCOLOGY GROUP INC. Quality Assurance. Treatment Planning Benchmark

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1 TRANS-TASMAN RADIATION ONCOLOGY GROUP INC. Quality Assurance Treatment Planning Benchmark PORTEC-3/ TROG Randomised Phase III Trial Comparing Concurrent Chemoradiation and Adjuvant Chemotherapy with Pelvic Radiation Alone in High Risk and Advanced Stage Endometrial Carcinoma Prepared by: TROG COO Version 2: December 2008

2 1. PURPOSE The treatment planning benchmark is an evaluation tool that aims to assess the processes undertaken by an institution when planning a patient for radiotherapy treatment. This will include contouring of target volumes, treatment planning, prescription and dose distribution. A standard CT dataset has been chosen. The sample case must be planned as per protocol instructions and aims to evaluate an institution's ability to comply with the protocol constraints. Each participating clinician must successfully complete the benchmarking exercise prior to trial participation and patient accrual. Completion of this benchmarking exercise is expected within one month from receipt of the guidelines. Following completion of this planning exercise, the treatment planning data will be sent to the TROG Central Operations Office (TCOO). The benchmarking exercise will be evaluated within one week of receipt at the TCOO by a nominated reviewer using the TROG Central Quality Management System and 3D QA review software. Treatment planning data must be exported in RTOG or DICOM RT format. In addition, a mock prescription sheet must be completed and supplied as either a hardcopy or as a screen capture. The exported treatment planning data must include all structure and dose information including DRRs and a DVH. If your planning system is unable to export any of the required information, hard copies will be required. Instructions for exporting planning data in electronic format are provided in Section 4.6 of this document. In addition, COLOUR COPIES (screen capture images or printouts) of the RT treatment plan dose data at the level of the ICRU reference point must be provided. 2. PORTEC-3 BACKGROUND The primary objective of this study is to establish overall survival and failure-free survival of patients with high-risk and advanced stage endometrial carcinoma treated after surgery with concurrent radiotherapy and chemotherapy, followed by adjuvant chemotherapy, in comparison with patients treated with pelvic radiation alone. 3. PATIENT CASE HISTORY A 59 year old woman presented with several episodes of vaginal bleeding. An ultrasound revealed a thickened endometrial lining. Hysteroscopy confirmed a grossly abnormal endometrium with abnormal vascularisation. Curettage revealed a grade 3 endometrioid carcinoma. She underwent total abdominal hysterectomy and bilateral salpingo-oophorectomy. The final diagnosis was stage IIA, grade 3 endometrial cancer. Please Note: The patient had a tampon inserted at the time of CT. The tampon was only partially inserted and does not extend into the superior vaginal vault. The tampon is positioned to mark the lower level of the vault, i.e. bottom of tampon = introitus.

3 4. QA PROCEDURE 4.1 Medical Physicist or Planning Radiation Therapist Loads Planning CT Scans The DICOM CT dataset must be loaded onto the treatment planning system. 4.2 Radiation Oncologist and Radiation Therapist to Read Relevant Information Before Commencing Planning. Protocol: Section 7.3 Radiotherapy and Appendix E Radiotherapy Specifications. Please read the TROG QA Radiotherapy Guidelines provided. Review the patient case history. 4.3 Prepare Treatment Plan Conduct treatment planning as per protocol, including: - contouring target volumes and regions of interest on all relevant slices before commencing planning - adherence to protocol prescription and dose constraints The planning information provided should clearly illustrate ICRU reference points and dose. 4.4 Dose Calculation Each treatment plan shall be computed and exported with the following specifications: Dose matrix maximum grid spacing should be calculated according to standard hospital practice. Data shall be presented in absolute dose as export in relative dose mode is not fully supported by some commercial systems All exported data shall be contained in a single directory for each patient. The sampling resolution for the dose volume histogram data shall be 0.1cm for contoured structures, 0.2cm for all other tissue. The bin width shall be 10cGy. The target volume and organs at risk will be named as defined in the TROG QA radiotherapy guidelines (please see section 6). Contouring shall be included on all relevant CT slices for all structures. The interpolation algorithm on the treatment planning computer may be used if it is not normal clinical practice to contour on all slices. 4.5 Document Treatment Prescription Use standard department forms/treatment sheets to document the treatment prescription 4.6 Digital Plan & Dosimetric Data Instructions for exporting treatment planning data from each of the commercial treatment planning systems are available from the TROG COO.

4 4.6.1 For planning and dosimetric data to be submitted digitally, the trial case must be planned on a planning system that is capable of exporting data in either: - RTOG Data Exchange Format - DICOM RT All relevant data should be exported including: - Planning CT - Structures (organs at risk and target volumes) - Dose - Treatment plan - Dose volume histograms - DRRs (if planning system capable) 4.7 Hard Copy Plan & Dosimetric Data Provide print colour copies or electronic screen captures of the final treatment slices for: - ICRU reference point plane If your Treatment Planning System does not export DVH data, then printed copies or electronic screen captures of dose volume histogram information must be provided for: - CTV - PTV - Both Kidneys (if applicable) - Spinal Cord If your Treatment Planning System does not export digitally reconstructed radiographs (DRR) data, then print copies or electronic screen captures of DRRs for all treatment planning fields must be provided e.g. Pinnacle. 4.8 Data Submission The requested data should be submitted within one month from receipt of the exercise documentation and include the "Site Information" form. Please post to: TROG Central Operations Office Calvary Mater Newcastle Locked Bag No. 7, Hunter Region Mail Centre NSW Feedback Report on Compliance The TROG Central Operations Office will provide a written report to sites on their compliance with the protocol guidelines within one week of receipt of the required documentation Queries and Troubleshooting Any queries or requests for clarification should be directed to: Dr Pearly Khaw Michael Bailey Radiation Oncologist Senior Radiation Oncology Medical Physicist Tel: Tel: Fax: Fax: Pearly.Khaw@petermac.org Michael.Bailey@sesiahs.health.nsw.gov.au

5 5. PORTEC-3 RADIOTHERAPY (protocol section 7.3) 7.3 Radiotherapy External beam pelvic radiation Target Volume: The clinical target volume (CTV) consists of the proximal 1/2 of the vagina, the parametrial tissues, and the internal, external and distal common iliac lymph node regions up to the upper S1 level. In case of external or internal iliac lymph node involvement the common iliac lymph node regions are to be included up to the aortic bifurcation. In case of common iliac node involvement the aortic bifurcation should be included up to the lower peri-aortic region (margin of at least 2 cm above the highest lymph node region involved). In case of peri-aortic involvement, the peri-aortic lymph node region should be included up to the higher para-aortic region (margin of at least 2 cm above the highest lymph node region involved). If a complete bilateral lymphadenectomy has been performed with at least 12 lymph nodes from all sites (left and right external, internal and common iliac regions) and all lymphnodes are free of tumor at histopathologic evaluation, the upper border of the CTV is at the iliac bifurcation. The Planning Target Volume (PTV) consists of the CTV with a 7-10 mm margin. A detailed description and guidelines for delineation of the CTV are provided in Appendix E. Positioning and verification: The choice of the supine or prone position is left to the treating physician. In the case of prone positioning, the use of a belly-board is recommended. Treatment with a full bladder is advisable. A CT scan for simulation and planning is mandatory. The positioning of the patient during simulation and treatment should be reproduced with the aid of orthogonal laser beams. The positioning should be verified by electronic portal images or megavolt films at least twice, at the beginning of treatment and after one week. Use of a verification and correction procedure is recommended. Dose and fractionation: 48.6 Gy, at 1.8 Gy per fraction, specified at the isocenter, 5 fractions a week. This dose is equivalent to 46.6 Gy in 2 Gy fractions for an α/β ratio of 3 (late effects), and to 47.8 Gy in 2 Gy fractions for α/β 10 (acute effects). For UK centers, a dose range of 45 to 50.4 Gy at 1.8 Gy fractions is allowed, with a recommended dose of 48.6 Gy. Treatment should preferably be started within 4-6 weeks after surgery, but no later than 8 weeks after surgery. Treatment breaks should be avoided, and overall treatment time should be kept within 6 weeks. Treatment breaks due to public holidays and machine maintenance should not exceed 2 days. Technique: A planned volume (four-field box, 3-field or multiple field technique) will be employed, with individual shielding in all fields. Use of CT-scan based three-dimensional treatment planning is mandatory. The dose is be specified at the ICRU reference point. Homogeneity requirements should be according to the ICRU-50 recommendations. IMRT

6 is allowed if a center has competed clinical introduction of standard IMRT for pelvic fields and adequate QA procedures are employed. Permission for use of IMRT will be granted on an individual basis after consultation with the study coordinators. Patients should be treated with megavolt photons from a linear accelerator, using at least 6 MV photons, but treatment with higher energies (10 MV or higher) is recommended. A dummy run or quality control survey of treated patients will be done during the course of the trial.

7 6. PORTEC-3 RADIOTHERAPY (Appendix E of protocol) APPENDIX E. RADIOTHERAPY SPECIFICATONS Description of the Clinical Target Volume (CTV) The CTV should include the upper 50% of the vagina, the vaginal tissues cranial to the vaginal marker, the paravaginal / parametrial soft tissues, and the distal common, external, and internal iliac lymph node regions as specified in section (page 13-14). Inclusion of the subaortic pre-sacral nodes is recommended for tumors with involvement of the cervix. Contouring of the CTV should be done according to literature data and taking institutional preferences and practices into account. Useful guidelines and contouring atlas can be found at: - RTOG website (consensus guidelines for delineation of the CTV): - Taylor A, Rockall AG, Reznek RH, Powell MEB. Mapping pelvic lymph nodes: guidelines for delineation in intensity-modulated radiotherapy. Int J Radiat Oncol Biol Phys. 2005;63: and contouring atlas: - Taylor A, Rockall AG, Powel MEB. An Atlas of the Pelvic Lymph Node Regions to Aid Radiotherapy Target Volume Definition. Clinical Oncology 2007 doi: /j.clon Small W Jr., Mell LK, Anderson P et al. Consensus guidelines for the delineation of the clinical target volume for intensity modulated pelvic radiotherapy in the postoperative treatment of endometrial and cervical cancer. Int J Radiat Oncol Biol Phys 2007, Nov 23 General guideline for contouring CTV: The superior portion of the CTV should be defined by adding a 7 mm margin around the common iliac vessels seen on the axial CT slice. The CTV should be extended to include adjacent visible or suspicious lymph nodes, lymphoceles, and pertinent surgical clips, and modified to exclude bone, psoas muscle, and bowel. The CTV should follow the external and internal iliac vessels bilaterally, and a 7 mm margin around the vessels should be maintained, excluding bone, bowel, or muscle, including suspicious lymph nodes, lymphoceles, and pertinent surgical clips. To cover the presacral region, the volumes on each side of the pelvis should be connected with a 10-mm strip over the anterior sacrum on the level of S1-S2. Vaginal cuff tissue frequently extends superior to the vaginal marker, and this tissue should be included in the CTV. The volume of tissue to be included above the vaginal marker will depend on the location of adjacent small bowel (that will not be considered CTV) and the amount of soft tissue present. Generally, the minimum tissue to be included above the vaginal marker or vaginal cuff tissue is 1 cm. At the inferior portion of the CTV the internal iliac vessels may become poorly visualized. In this case, the CTV should be bounded posteriorly by the piriformis muscle, even if the CTV extends more than 7 mm beyond visible vasculature.

8 Ensure the lateral border of the volume extends to the psoas muscle and pelvic sidewall. Continue the medial border around the external iliac vessels posteriorly, parallel to the sidewall, until it joins the medial contour of the internal iliac vessels to encompass the obturator region. This creates a strip medial to the pelvic sidewall that should be at least 17 mm wide. The distal lateral external iliac nodes should be encompassed if there is other iliac lymph node involvement, and in that case the contour should be extended around the external iliac artery anterolaterally along the iliopsoas muscle by an additional 10 mm. A uniform 3-dimensional CTV expansion of 7-10 mm is used to obtain the PTV. Because of internal organ movement due to changes in bladder and rectum filling the CTV-PTV margin for the upper vaginal region should be 12mm anterior-posterior and superiorinferior. An alternative way to account for internal organ movement due to changes in bladder filling is to obtain planning CT scans both with a full and empty bladder. The vaginal/parametrial CTV should be outlined on both CT scans and these volumes should then be merged to form an integrated target volume (ITV). This ITV should be used for treatment planning to account for daily variations in the location of the vaginal cuff related to variation in bladder filling. It is recommended to use a protocol for standard bladder filling during RT. In case of huge rectal filling at the planning CT scan, a repeat scan is recommended after a few days (and after using laxatives as appropriate).

9 7. PORTEC-3 RADIOTHERAPY (Taken from TROG QA Radiotherapy Guidelines) ORGANS AT RISK (OAR) CONTOURING There will be additional requirements for contouring regarding organs at risk. The following regions of interest must be contoured on every CT slice: Entire volume of both the Left and Right Kidney (if appropriate- i.e. using extended fields). Spinal Cord, extending 2cm above the most superior border of the treatment field and inferiorly to the level where cauda equina begins or 2cm below the most inferior border of the treatment field. DOSE REPORTING External Beam Radiation Therapy- The absorbed dose in at the ICRU reference point must be reported. The present system of recommendations for reporting is based on the selection of a point within the PTV, which is referred to as the ICRU Reference point. This reference point will be used for reporting purposes to confirm correct prescription of dose. Frequently dose is prescribed to the ICRU reference point and this value can be easily assessed, however there are instances where dose is not prescribed to the ICRU reference point or where the overall dose is achieved using multiple dose points or weight points. In such instances, a reporting reference point must be chosen using the following guidelines: For each Planning Target Volume, a reference point must be chosen, which satisfies ICRU 50 criteria for reference points and clearly indicates correct prescription of dose (i.e. the point must be placed where the dose is equal to the prescribed dose, provided that this location is clinically relevant and in the centre or central parts of the PTV). The ICRU Reference point shall be selected according to the following general criteria: 1. The dose at the point should be clinically relevant and representative of the dose throughout the Planning Target Volume (PTV), 2. The point should be easy to define in a clear and unambiguous way, 3. The point should be selected where the dose can be accurately determined (physical accuracy), 4. The point should be selected in a region where there is no steep dose gradient. These recommendations will be fulfilled if the ICRU Reference point is located firstly, at the centre, or in the central parts of the Planning Target Volume, and secondly, on or near the central axis of the beam(s). In some situations, it is not possible to define the ICRU Reference Point at the centre of the Planning Target Volume. In these conditions, one has to select the ICRU Reference

10 Point inside the tissues represented by the PTV, and in a place where dose specification is considered to be meaningful. Such a place could be the region where the tumour cell density is considered to be at its maximum. Placement of the reference point must be done such that the above criteria are fulfilled and so that the dose at this point represents 100% of the prescribed dose for each phase of treatment. In addition the point must be clearly labelled as "ICRU Reference Point" and the labelling refer to the phase or anatomical region being treated. The location of the reference point must also be recorded e.g. x,y,z co-ordinates in relation to the CT data-set.

11 SITE NAME: PORTEC3/TROG 08.04: SITE INFORMATION IMMOBILISATION DEVICES USED FOR ENDOMETRIAL PELVIC TREATMENT: ICRU REFERENCE POINT LOCATION: X Y Z DOSE MATRIX GRID SIZE: x mm 3D TREATMENT PLANNING SYSTEM: Vendor: Version: Please complete the following page with site contact details.

12 CONTACT DETAILS FOR RADIATION ONCOLOGIST Name: Position: Phone: Fax: CONTACT DETAILS FOR RADIATION THERAPIST Name: Position: Phone: Fax: CONTACT DETAILS FOR MEDICAL PHYSICIST Name: Position: Phone: Fax: CONTACT DETAILS FOR DATA MANAGER / CLINICAL TRIALS COORDINATOR Name: Position: Phone: Fax:

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