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Phase I trial of pre-opera0ve intensity modulated proton radia0on (IMPT) with

simultaneous boost to high risk margin for retroperitoneal sarcomas

DeLaney et al. MGH – Abstract at PTCOG 2016

Goal:

selec<vely escalate retroperitoneal sarcoma (RPS) preopera<ve radia<on dose to

tumor volume (CTV2) judged at high risk for posi<ve margins, aiming to reduce local

recurrence(LR).

Pa<ents > 18 years with primary or locally recurrent RPS

preopera<ve IMPT, 50.4 GyRBE/28 frac<ons, to CTV1 (GTV and adjacent <ssues) with

integrated boost to CTV2 to doses of 60.2, 61.6, and 63.0 GyRBE in 28 frac<ons of 2.15,

2.20, and 2.25 GyRBE respec<vely.

Phase I study primary objec<ve was determina<on of maximum tolerated dose (MTD) to

CTV2, to be further tested in subsequent phase II.

Results:

11 pa<ents were accrued to increasing IMPT dose levels without acute dose limi<ng

toxici<es preven<ng dose escala<on to MTD.

Acute toxicity mild. No radia<on interrup<ons. No unexpected periopera<ve morbidity.

8 months postopera<vely, one pa<ent developed hydronephrosis treated by stent; Ureter

received 57.5 GyRBE. Subsequently constrained to 50.4 GyRBE.

With 18-month median follow-up, there were no LRs.

Conclusions:

IMPT dose escala<on to CTV2 to 63 GyRBE achieved without DLT; phase II

IMPT study started to accrue to that dose.