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N. Macleod
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P3.04 - Clinical Design, Statistics and Clinical Trials (ID 720)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Clinical Design, Statistics and Clinical Trials
- Presentations: 1
- Moderators:
- Coordinates: 10/18/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
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P3.04-006 - SYSTEMS-2: Randomised Phase II Trial of Standard Versus Dose Escalated Radiotherapy for Pain in Malignant Pleural Mesothelioma (ID 9890)
09:30 - 09:30 | Author(s): N. Macleod
- Abstract
Background:
Pain is common in malignant pleural mesothelioma (MPM) and tends to be poorly responsive to analgesia. Radiotherapy has traditionally been used for pain control, without robust supportive evidence. ‘SYSTEMS’ was the first prospective study to use validated endpoints to assess pain response to a standard dose of palliative radiotherapy (20Gy/5#). This multicentre, phase II trial demonstrated clinically meaningful improvements in pain in one third of patients at week 5, with minimal toxicity. The SYSTEMS-2 study is comparing pain control at week 5 in the standard arm (20Gy/5#) with that in the dose escalated arm (36Gy/6#).
Method:
Recruitment target is 112 patients across 15-20 UK hospitals. Eligible patients have: • MPM diagnosis • ECOG PS 0-2 • Pain score ≥ 4/10 after analgesia optimisation • CT scan with contrast within 8 weeks of starting radiotherapy • Radiotherapy plan compatible with dose escalated arm prior to randomisation. Wire markers are used to indicate sites of pain at radiotherapy planning and doses to organs at risk (OAR) are minimised through advanced planning techniques (e.g. intensity modulated radiotherapy- IMRT). (Figure 1) The primary outcome is pain control at the radiotherapy site at week 5. A clinically significant response is defined as a drop of ≥ 2 points in a validated numerical rating scale. Radiological response will be assessed at week 9. Figure 1
Result:
SYSTEMS-2 opened to recruitment in August 2016. More than 30 patients have been screened across a total of 5 UK sites and 15 patients have been randomised. A further 19 sites are currently in set-up. PTV coverage and OAR doses have been consistently achieved, despite large treatment volumes and nearby radiosensitive structures. Radiological responses have been seen across both cohorts.
Conclusion:
This study will provide robust and accurate symptom response data for palliative radiotherapy in MPM and help to establish the optimal dose and fractionation.
