Stereotactic radiotherapy on brain metastases with recent hemorrhagic signal: STEREO-HBM, a two-step phase 2 trial

Table 2 Table caption

	Before initiation of treatment D-15 to D0	Stereotactic irradiation week FSRT Treatment of all lesions in 7-10 days maximum	End of irradiation W1 (1 week after the end of irradiation)	Follow-up visits after treatment				Follow-up after progression^f
	Before initiation of treatment D-15 to D0		End of irradiation W1 (1 week after the end of irradiation)	Each week up to 2 months after end of treatment W2 to W9	4 months after end of treatment W16	6 months after end of treatment W24	Every 3 months up to disease progression^c	Follow-up after progression^f
Stereotactic irradiation		Each brain metastasis (hemorraghic or not) will be treated at 30 Gy in 3 fractions of 10 Gy / fraction every 2 days on maximum 7 days
Signature of informed consent	✓
Clinical exam including:
- Disease medical history, weight, height, SC, PS) Patient pronostic (DS-GPA)	✓
- Complete clinical evaluation and neurological examination		✓	✓	✓	✓	✓	✓
- Evaluation of toxicities		✓(once a week)	✓	✓	✓	✓	✓	✓
Biological assessment^a
- Complete Blood Count	✓		✓	✓	✓	✓	✓
- Creatinin-^a	✓		✓	✓^b	✓	✓	✓
Imagery including:	✓
- Cerebral scan	✓		✓	✓^b	✓	✓
- Cerebral MRI with T1 sequency Followed by Spectro-MRIe (ancillary study)	✓	✓ (in case of neurological degradation due to treated lesions)	✓	✓^b	✓	✓	✓ ✓
Quality of life questionnaires (EORTC QLQ C30 and BN20)	✓			✓ Only at 1 month	✓	✓	✓^d

^aCreatinin must be performed before MRI
^b4 weeks and 8 weeks after the end of irradiation (W4 and W8)
^cEvery 3 months up to at least one target irradiated lesion in disease progression
^donly every 6 months
^eSpectro-MRI is performed at the same time of standard cerebral MRI and only applies to patients who have given their signed consent
^fAfter progression, a survival status will be collected every 3 months with persistent toxicities due to radiotherapy

ISSN: 1471-2407