The Role of Stereo-tActic BoDy RadIotherApy iN Oligo-Progressive MalignanT Disease

Launched by UNIVERSITY HEALTH NETWORK, TORONTO · Oct 8, 2019

Keywords

ClinConnect Summary

This clinical trial is investigating a treatment called stereotactic body radiation therapy (SBRT) for patients with certain types of metastatic cancers, specifically breast and genito-urinary cancers, who are experiencing a situation known as oligo-progression. This means that while most of their cancer is responding to treatment, a few specific areas are not. The aim of this study is to see if delivering high doses of focused radiation to these specific problem areas can help control the disease while minimizing damage to surrounding healthy tissues.

To participate in this trial, you must be at least 18 years old and have five or fewer problematic cancer spots that can be treated with radiation. You'll be asked to fill out quality of life questionnaires and have imaging tests before and after treatment, and you'll be monitored for up to two years. Additionally, you may have the option to provide blood samples at different times to analyze cancer-related genetic material. This study is currently recruiting participants, so if you or someone you know fits the criteria, it could be a chance to explore a new treatment option.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • ≥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