Using targeted radiation therapy for patients with specific types of metastatic cancer
The Role of Stereo-tActic BoDy RadIotherApy iN Oligo-Progressive MalignanT Disease
This study is testing if a focused type of radiation therapy can help people with certain metastatic breast and genito-urinary cancers feel better while they are also receiving other treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 130 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Health Network, Toronto Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT04122469 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of stereotactic body radiation therapy (SBRT) in patients with oligo-progressive metastatic breast and genito-urinary cancers. It aims to treat patients who have a limited number of metastatic sites while they are undergoing systemic therapy. Participants will receive focused radiation to targeted lesions, with follow-up assessments at regular intervals over two years to evaluate treatment outcomes. The goal is to determine if SBRT can provide better management of their cancer progression compared to standard treatment approaches.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with 5 or fewer sites of oligo-progressive breast or genito-urinary cancers that are suitable for targeted radiation treatment.
Not a fit: Patients with extensive metastatic disease or those whose tumors are not amenable to stereotactic body radiation therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could offer a new treatment option that may improve outcomes for patients with oligo-progressive metastatic cancers.
How similar studies have performed: Previous studies have shown promising results with SBRT in treating oligo-metastatic disease, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Toronto, Ontario
- Princess Margaret Cancer Centre — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: Rachel Glicksman, MD
- Email: rachel.glicksman@uhn.ca
- Phone: 416-946-4961
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.