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

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ClinicalTrials.gov Identifier: NCT04122469
Recruitment Status : Recruiting
First Posted : October 10, 2019
Last Update Posted : October 29, 2019
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

Brief Summary:

Systemic therapy is the main treatment for patients with metastatic cancers. Oligo-progressionhas 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 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


Condition or disease Intervention/treatment Phase
Malignancy Radiation: Stereotactic Body Radiotherapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Role of Stereo-tActic BoDy RadIotherApy iN Oligo-Progressive MalignanT Disease
Actual Study Start Date : September 11, 2019
Estimated Primary Completion Date : September 20, 2021
Estimated Study Completion Date : September 20, 2023

Arm Intervention/treatment
Experimental: Intervention
Receiving SBRT.
Radiation: Stereotactic Body Radiotherapy
A previous study found that in four of the five metastatic GI patients, SBRT increased the duration of effective systemic therapy with no significant additional toxicities. There have been small number of case reports in lung and renal cancers, which suggest the potential for improvement in progression free survival. The purpose of this study is to evaluate the safety, and efficacy of SBRT in this patient population




Primary Outcome Measures :
  1. Safety of SBRT in OP malignancies [ Time Frame: 24 month period ]
    To determine the safety of SBRT in OP malignancies over a 24-month follow-up period using CTCAE v5.0.

  2. Efficacy of SBRT in OP malignancies [ Time Frame: 24 month period ]
    To determine the efficacy of SBRT in OP malignancies over a 24-month follow-up period by evaluating progression-free survival. Radiographic local control of irradiated areas and local disease will also be used to determine efficacy by using Response Evaluation Criteria in Solid Tumors (RECIST).

  3. Feasibility of SBRT in OP malignancies [ Time Frame: 24 month period ]
    To determine the feasibility of SBRT in OP malignancies over a 24-month follow-up period using the a quality of life questionnaire (the EORTC QLQ-C30 questionnaire).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients ≥18 years accrued at the Princess Margaret Cancer Centre
  • 3 or less sites of intra or extra-cranial oligo-progressive 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

  • 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 a GI solid malignancy (oesophageal, stomach, liver, pancreatic, cholangio-carcinoma, small bowel, colorectal and anal cancers) and adrenal metastases OR,
    • Pathologically confirmed breast cancer OR,
    • Pathologically confirmed prostate cancer
  • 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…)
  • 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.
  • Life expectancy > 6 months
  • Able to provide written consent
  • ECOG performance status 0-3

Exclusion Criteria:

  • ≥4 progressive metastases
  • Her 2 positive (Her 2 +) breast cancer patients
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04122469


Contacts
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Contact: Aisling Barry, MD 4169464501 ext 2127 aisling.barry@rmp.uhn.ca

Locations
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Canada, Ontario
Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Aisling Barry, MD    416-946-4501 ext 2127    aisling.barry@rmp.uhn.ca   
Sponsors and Collaborators
University Health Network, Toronto

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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT04122469     History of Changes
Other Study ID Numbers: 18-6047
First Posted: October 10, 2019    Key Record Dates
Last Update Posted: October 29, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Health Network, Toronto:
SBRT
Additional relevant MeSH terms:
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Neoplasms