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

  • STATUS
    Recruiting
  • End date
    Sep 20, 2023
  • participants needed
    80
  • sponsor
    University Health Network, Toronto
Updated on 4 October 2022
carcinoma
breast cancer
metastasis
docetaxel
primary cancer

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 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

Details
Condition Malignancy, Breast Cancer Metastatic, Genito-urinary
Treatment Stereotactic body radiotherapy
Clinical Study IdentifierNCT04122469
SponsorUniversity Health Network, Toronto
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Adult patients ≥18 years accrued at the Princess Margaret Cancer Centre
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)
at least one lesion should be planned for SBRT
Tumor mass amenable to SABR (≤6cm in size)
OR 5 or less sites of intra or extra-cranial oligo-progressive prostate, bladder and
Confirmation of diagnosis
renal cell carcinomas
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…)
Progression of a metastasis according to RECIST 1.1 criteria7
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
Unambiguous development of a new lesion from the time of scan taken prior to starting ST
For oligo-progressive disease: receiving any form of ST for at least 3 months with (ST breaks are permitted)
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
Able to provide written consent
evidenced by >2 consecutive images within the past 4-6 months
ECOG performance status 0-3

Exclusion Criteria

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
≥6 progressive 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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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