EMBRACE II: Accreditation and patient accrual

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Theodore Lynch
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1 EMBRACE 9 th Annual Meeting Vienna Study Office EMBRACE II: Accreditation and patient accrual

2 Centers recruiting and ready to recruit patients 16 centers have finished the accreditation process and are ready to recruit patients 10 centers are recruiting patients March 2018: EMBRACE II: 187 patients Included (after 24 months) Aarhus, Denmark: Amsterdam AMC, The Netherlands: Amsterdam AVL, The Netherlands Arnhem, The Netherlands: Cambridge, UK: Edmonton, Canada Leeds, UK Leiden, The Netherlands: Ljubljana, Slovenia: London (Northwood), UK Maastricht, The Netherlands Mumbai, India: Oslo, Norway: Paris IGR, France Utrecht, The Netherlands: Vienna, Austria: 38 patients included 15 patients included 14 patients included 2 patients included 13 patients included 6 patients included 10 patients included 22 patients included 34 patients included 33 patients included

3 EMBRACE I: status 12/2009 (18 mths) Start of patient accrual in July 2008 Vienna Aarhus Utrecht Leiden Leuven Ljubljana London Arnhem Paris Mumbai Pittsburgh Milwaukee Kaposvar Maastricht 14 centers

4 EMBRACE I Patient Accrual 12/2009 (18 months) patients Ljubljana Arnhem Paris Leuven Leiden Utrecht Mount Vernon Vienna Aarhus

5 Accreditation process

6 STEP 1 Submission of compliance questionnaire Approval by study coordinators STEP 2 Training: contouring and dose planning Self-assessment of contouring and dose planning STEP 3 STEP 4 Submission: EBRT contouring EBRT dose planning BT contouring (new centers) Registration of 5 patients in a registration database in 6 months (new centers) Approval by study coordinators Ready to start inclusion

7 Accrediation process Overview in numbers EMBRACE II 03/ almost/fully compliant 78 compliance questionnaires 37 completed EBRT contouring 30 completed EBRT dose planning 12 not compliant 7 dropped out 15 former EMBRACE centers 7 BT contouring submissions 3 centers with test patient submissions

8 STEP 1 Submission of compliance questionnaire Approval by study coordinators STEP 2 Training: contouring and dose planning Self-assessment of contouring and dose planning STEP 3 STEP 4 Submission: EBRT contouring EBRT dose planning BT contouring (new centers) Registration of 5 patients in a registration database in 6 months (new centers) Approval by study coordinators Ready to start inclusion

9 Step 1: Submission of compliance questionnaire Go to: goo.gl/nbt8ud After submitting the questionnaire, we will evaluate the following criteria: Treatment of >10 patients per year qualifying for enrolment in EMBRACE II Both EBRT and BT are performed in the centre Routine use of IMRT or VMAT Routine use of daily IGRT with bony fusion Routine use of MRI guided IGABT with applicator in situ (at least for first fraction) Routine use of the combined intracavitary-interstitial technique when needed (~20-50% of patients)

10 STEP 1: Feedback on compliance questionnaire Compliant (all compliance criteria fulfilled): Near-compliant (minor changes needed): Centers need to move from weekly imaging to daily IGRT Centers have the IC/IS applicator available, but has only treated a few patients Centers use IMRT routinely for other pelvic indications, but need to implement this for cervix cancer Major changes needed: No routine in needles (IC/IS is not available in the department) Centers are treating <10 patients per year with both EBRT and BT Centers are doing CT based brachytherapy No routine use of IMRT/VMAT in cervix nor other pelvic indications Centers can continue with the accreditation Please submit a new questionnaire

11 The compliance questionnaire will be closed on 30 th April this year!

Submission: EBRT contouring EBRT dose planning BT contouring (new centers) Registration of 5

12 STEP 1 Submission of compliance questionnaire Approval by study coordinators STEP 2 Training: contouring and dose planning Self-assessment of contouring and dose planning STEP 3 STEP 4 Submission: EBRT contouring EBRT dose planning BT contouring (new centers) Registration of 5 patients in a registration database in 6 months (new centers) Approval by study coordinators Ready to start inclusion

13 Step 2: Training EBRT contouring & dose planning Two training cases available on CCMO Optional but highly recommended Not evaluated by us but reference contours for targets and organs at risk available step-by-step guide to creating the ITV

14 STEP 1 Submission of compliance questionnaire Approval by study coordinators STEP 2 Training: contouring and dose planning Self-assessment of contouring and dose planning STEP 3 STEP 4 Submission: EBRT contouring EBRT dose planning BT contouring (new centers) Registration of 5 patients in a registration database in 6 months (new centers) Approval by study coordinators Ready to start inclusion

15 STEP 3: Submission of EBRT contouring & dose planning Last chance to submit: June 1 st, 2018 Last chance to pass: June 30 th, 2018

16 Evaluation of contours GTV CTV HR CTV LR CTV N CTV E PAN Presacral Obturator ITV 45 Bowel

17 A few important remarks: Please be aware that we need submissions of your local principal investigator for evaluation! Regarding contours: Make sure to use a fast internet connection to ensure stability with the ACT system Please send a short to the study office after submission Regarding dose plans: Submission of DICOM files is possible but not mandatory

different scenarios of tumor response Last chance to

18 STEP 3: Submission of BT contours (only new centers) Contours for two different cases to illustrate two different scenarios of tumor response Last chance to submit: June 1 st, 2018 Last chance to pass: June 30 th, 2018

19 Evaluation of contours GTV CTV HR CTV IR Bladder Rectum Sigmoid Bowel

20 A few important remarks: Please be aware that we need submissions of your local principal investigator for evaluation! The course will only be opened after you have finished EBRT contours and dose plan Make sure to use a fast internet connection to ensure stability with the ACT system Please send a short to the study office after submission

21 STEP 1 Submission of compliance questionnaire Approval by study coordinators STEP 2 Training: contouring and dose planning Self-assessment of contouring and dose planning STEP 3 STEP 4 Submission: EBRT contouring EBRT dose planning BT contouring (new centers) Registration of 5 patients in a registration database in 6 months (new centers) Approval by study coordinators Ready to start inclusion

22 STEP 4: Registration of 5 patients in test database (only new centers) Registration of 5 new consecutive patients in a registration database within 6 months after passing EBRT and BT accreditation Reporting of: Status at diagnosis Status at brachytherapy Treatment and DVH parameters Additionally: Screen dumps of EBRT and BT contours and dose plans Cartoons documenting clinical examination at diagnosis and BT Last chance to submit: January 1 st, 2019 Last chance to pass: March 1 st, 2019

23 A few important remarks: Please provide comments if you are violating the hard dose constraints Patients need to be treated according to the study protocol

24 Accrediation process Overview in numbers EMBRACE II March almost/fully compliant 78 compliance questionnaires 37 completed EBRT contouring 30 completed EBRT dose planning 12 not compliant 7 dropped out 15 former EMBRACE centers 7 BT contouring submissions 3 centers with test patient submissions

25 Centers recruiting and ready to recruit patients 16 centers have finished the accreditation process and are ready to recruit patients 10 centers are recruiting patients For centers in the accreditation process: Take note of the deadlines! June 2018 and January 2019 Aarhus, Denmark: Amsterdam AMC, The Netherlands: Amsterdam AVL, The Netherlands Arnhem, The Netherlands: Cambridge, UK: Edmonton, Canada Leeds, UK Leiden, The Netherlands: Ljubljana, Slovenia: London (Northwood), UK Maastricht, The Netherlands Mumbai, India: Oslo, Norway: Paris IGR, France Utrecht, The Netherlands: Vienna, Austria: For centers not yet recruiting: Start now!

26 EMBRACE I: after 53 months EMBRACE II: 183 patients included (after 24 months) EMBRACE I experience and plan for EMBRACE II: annual accrual rate ~200+ patients from year 2 onwards

27 waiting for a significant move?! to fill the gap between 59 centers fully compliant some steps such as EBRT, BT, test patients and: 16 centers ready to recruit patients The accreditation has to be completed until the next annual meeting!

EMBRACE I Data completeness Database dump

EMBRACE 10 th Annual Meeting EMBRACE I Data completeness Database dump Christian Kirisits, Sofia Spampinato, Kari Tanderup Vienna, Friday, 23 th March Saturday, 24 th, March 2018 EMBRACE I Overview 23