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Radiation Therapy

SBRT for Oligo-Progressive Cancer (RADIANT Trial)

N/A
Recruiting
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Pathologically confirmed GU cancer (such as prostate cancer, bladder cancer, or radiologically or pathologically confirmed RCC).
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 month period
Awards & highlights

RADIANT Trial Summary

This trial is investigating whether using high doses of focused radiation (SBRT) to treat oligo-progression (a subset of cancer cells that develop heterogeneity and resistant clones while receiving systemic therapy) is effective.

Who is the study for?
This trial is for adults with certain types of cancer, like breast or genitourinary cancers, who have a small number (5 or less) of progressing tumors despite systemic therapy. Participants must be able to consent and have at least one tumor that can be treated with SBRT. They should not have had prior radiotherapy that overlaps with the treatment area or any conditions listed in the exclusion criteria.Check my eligibility
What is being tested?
The study is testing Stereotactic Body Radiotherapy (SBRT) on patients with oligo-progressive metastatic disease—meaning their cancer has spread but only a few areas are getting worse while on standard treatments. The goal is to see if high-dose radiation focused on these few areas can control the disease without harming nearby organs.See study design
What are the potential side effects?
Potential side effects from SBRT may include skin reactions, fatigue, pain at the site of treatment, nausea, and inflammation around normal tissues close to where the radiation targets. These vary based on which part of the body receives radiation.

RADIANT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer is confirmed to be in the genitourinary tract.
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My cancer has grown by at least 5 mm while on treatment, as shown on two scans 2-3 months apart.
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My cancer has spread to 5 or fewer places in or outside my brain.
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I have up to 3 cancer lesions that are growing, and at least one can be treated with focused radiation.
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My tumor is small enough (6cm or less) for targeted radiation therapy.
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I have been diagnosed with breast cancer through a biopsy.
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My cancer has grown or spread according to specific medical criteria.
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I am scheduled for a targeted radiation treatment on at least one cancer lesion.
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My breast cancer has spread to 5 or fewer places that can be treated with targeted therapy.
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I can care for myself but may not be able to do heavy physical work.

RADIANT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 month period
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 month period for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Malignant Neoplasms
Feasibility of SBRT in OP malignancies
Safety of SBRT in OP malignancies

Side effects data

From 2008 Phase 2 trial • 20 Patients • NCT00350142
15%
ulcer
10%
vomiting
5%
Perforation
5%
pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
SBRT With Gem

RADIANT Trial Design

2Treatment groups
Experimental Treatment
Group I: Oligo-metastatic Breast CancerExperimental Treatment1 Intervention
Receiving SBRT.
Group II: Oligo-Progression; GUExperimental Treatment1 Intervention
Receiving SBRT.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic Body Radiotherapy
2017
Completed Phase 2
~220

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,482 Previous Clinical Trials
486,292 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still opportunities for patients to register in this trial?

"Affirmative. Clinicaltrials.gov's records demonstrate that, from 9/11/2019 to 10/6/2022, this clinical trial is actively recruiting 80 participants at a single site."

Answered by AI

How many individuals are being recruited to participate in this research?

"Affirmative. According to the information sourced from clinicaltrials.gov, this trial is recruiting participants and was first posted on September 11th 2019 with its most recent update occurring October 6th 2022. 80 patients must be enrolled at a single location for the study to proceed."

Answered by AI
~7 spots leftby Sep 2024