Precision radiation of immune checkpoint therapy resistant melanoma metastases (PROMMEL study): study protocol for a phase II open-label multicenter trial

Figures & data

Figure 1. Trial design.

Table 1. Overview of fractionation schedules, target volume definition and dosage for different target locations possible to use in the study.

	Lung lesions	Liver lesions	Abdominal lesions	Lymph nodes	Subcutan. lesions	Spine lesions	Non-spine bony lesions
Fractionation schedule
15 Gy × 3	x	x	–	–	–	–	–
10 Gy × 5	x	x	x	x	x	–	–
8 Gy × 5	–	–	x	x	x	x	x
Gross tumor volume (GTV), definition	NA	NA	NA	NA	NA	Tumor	NA
Clinical target volume (CTV), definition	Tumor^a	Tumor^a	Tumor^a,b	Entire lymph node	Tumor^a	Vertebra [37]	Tumor^a
CTV-PTV margins	Individual	Individual	Individual	Individual	Individual	^c	Individual
Isodose prescription (encompassing the PTV)^d	65–70%	65–70%	65–83%	65–83%	65–83%	^c	70–83%
Maximum target dose^e	150%	150%	120–150%	120–150%	120–150%	^c	120–140%^f

GTV: gross tumor volume. CTV: clinical target volume. PTV: planning target volume.

^aIncluding the diffuse growth at the borders. ^bThe entire adrenal gland comprises the CTV when treating adrenal lesions. ^cSee the study protocol for details. ^dAs a percentage of the maximum dose value in the center of the CTV. ^ePercent of prescribed dose. ^fEven homogeneous dosage may be considered in selected cases.

Cox BW, Spratt DE, Lovelock M, et al. International spine radiosurgery consortium consensus guidelines for target volume definition in spinal stereotactic radiosurgery. Int J Radiat Oncol Biol Phys. 2012;83(5):e597–e605.

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Data availability

Data sharing is not applicable to this study protocol since no data were generated or analyzed. Results from the PROMMEL study will be published and specific data will be available on reasonable request.