Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
University Health Network, Toronto
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Adult patients ≥18 years accrued at the Princess Margaret Cancer Centre
5 or less sites of intra or extra-cranial oligo-progressive, de novo oligo-metastatic, induced oligo-metastatic and repeat oligo-metastatic breast disease amenable to ablative treatment (including but not limited to radiotherapy, surgery, radio-frequency ablation);
o at least one lesion should be planned for SBRT
OR 5 or less sites of intra or extra-cranial oligo-progressive prostate, bladder and renal cell carcinomas
Tumor mass amenable to SABR (≤6cm in size)
Confirmation of diagnosis:
* Known/documented prior histological (for all excluding HCC) or radiological diagnosis (for HCC) of:
* Pathologically confirmed breast cancer OR,
* Pathologically confirmed GU cancer (such as prostate cancer, bladder cancer, or radiologically or pathologically confirmed RCC).
For prostate patients only: Known metastatic disease treated with ADT (patients who received other ST as first line treatment of mCSPC would be eligible; eg Docetaxel, Abiraterone…)
For prostate patients only: Known metastatic CRPC progressing on ST (Docetaxel, Abiraterone, Enzalutamide…)
For oligo-progressive disease: receiving any form of ST for at least 3 months with (ST breaks are permitted):
1. Radiographic evidence of ≤3 intra or extra-cranial lesions progressing (including nodal or distant). At least one lesion is suitable for SBRT. Each progressing lesion should fulfill at least 1 of the 3 following criteria for oligo-progression:
1. Progression of a metastasis according to RECIST 1.1 criteria7
2. Unambiguous development of a new lesion from the time of scan taken prior to starting ST
3. Progressive enlargement of a known metastasis on 2 consecutive imaging (CT or MRI) 2-3 months apart, while on ST, with a minimum 5 mm increase in size from baseline.
2. Remainder of metastatic disease stable or regressing, as per RECIST v1.1, evidenced by \>2 consecutive images within the past 4-6 months.
Able to provide written consent
ECOG performance status 0-3
You may not be if
≥6 progressive metastases
Evidence of spinal cord compression or acute event requiring urgent/emergency radiotherapy
Prior radiotherapy, with fields overlapping, resulting in excessive doses to organs at risk
Previous radical RT in the area of OP
Inability to safely treat all sites of progressing metastases
Patient cannot tolerate physical set-up required for SBRT
Treatment plan respecting normal tissue tolerances using dose fractionation specified within the protocol cannot be achieved
Active bowel obstruction, if treating abdominal/pelvic site
Neuroendocrine, lymphoma, myeloma or germ cell malignancies
Familial syndromes: Von Hippel-Lindau disease, Polycystic Kidney Disease, Hereditary Papillary RCC or Tuberous Sclerosis
Clareo Health | The Role of Stereo-tActic BoDy RadIotherApy iN Oligo-Progressive MalignanT Disease
