Status:
RECRUITING
The Role of Stereo-tActic BoDy RadIotherApy iN Oligo-Progressive MalignanT Disease
Lead Sponsor:
University Health Network, Toronto
Conditions:
Malignancy
Breast Cancer Metastatic
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Systemic therapy is the main treatment for patients with metastatic cancers. Oligo-progression has become a recognized entity for metastatic cancer and it is thought that a subset of cancer cells may ...
Eligibility Criteria
Inclusion
- 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):
- 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:
- Progression of a metastasis according to RECIST 1.1 criteria7
- Unambiguous development of a new lesion from the time of scan taken prior to starting ST
- 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.
- 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
- ≥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
Key Trial Info
Start Date :
September 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT04122469
Start Date
September 11 2019
End Date
September 1 2027
Last Update
February 10 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9