Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT04122469

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

Led by University Health Network, Toronto · Updated on 2025-02-10

130

Participants Needed

1

Research Sites

416 weeks

Total Duration

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AI-Summary

What this Trial Is About

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 develop heterogeneity and resistant clones while receiving systemic therapy. This results in overall tumor response but progression in metastatic sites. Current standard is to change systemic therapies. With advancing technologies, stereotactic body radiation therapy is being used to deliver high doses of focused radiation to the disease site, while minimizing risk of injury to the surrounding organs. SBRT is increasingly being used in patients presenting oligo-metastatic disease, and is recognized as having a potential for cure. This study will investigate the use of SBRT for breast and genito-urinary cancer patients with oligo-progression. Patients will be seen before and at the end of treatment and will be followed at 4 month intervals for up to 2 years. During the visits participants will complete quality of life questionnaires and will have standard of care imaging. Patients will also have the option to provide blood at baseline, during treatment, and at various follow up time points for analysis of ctDNA

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients 18 years or older treated at the Princess Margaret Cancer Centre
  • 5 or fewer progressing metastatic sites in breast cancer suitable for ablative treatment, including at least one planned for SBRT
  • 5 or fewer progressing metastatic sites in prostate, bladder, or renal cell carcinoma
  • Tumor size 6 cm or smaller suitable for stereotactic ablative radiation therapy
  • Confirmed diagnosis of breast cancer or genito-urinary cancers including prostate, bladder, or renal cell carcinoma
  • Prostate cancer patients with metastatic disease treated with androgen deprivation therapy or progressing on systemic therapy
  • Receiving systemic therapy for at least 3 months with stable or regressing other metastatic disease
  • Ability to provide written informed consent
  • ECOG performance status between 0 and 3
Not Eligible

You will not qualify if you...

  • More than 6 progressing metastatic sites
  • Evidence of spinal cord compression or urgent condition requiring emergency radiation
  • Prior radiotherapy overlapping treatment area causing excessive risk to organs
  • Previous radical radiotherapy in the oligo-progressive disease area
  • Unable to safely treat all progressing metastases
  • Cannot tolerate physical setup for SBRT
  • Treatment plan cannot meet normal tissue safety limits
  • Active bowel obstruction when treating abdominal or pelvic sites
  • Diagnosis of neuroendocrine, lymphoma, myeloma, or germ cell cancers
  • Familial syndromes such as Von Hippel-Lindau disease, Polycystic Kidney Disease, Hereditary Papillary Renal Cell Carcinoma, or Tuberous Sclerosis

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Princess Margaret Cancer Centre

Toronto, Ontario, Canada, M5G 2M9

Actively Recruiting

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Research Team

R

Rachel Glicksman, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

2

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