598 Participants Needed

SABR Techniques for Metastatic Disease

Recruiting at 4 trial locations
RO
HA
JL
Overseen ByJordanna Laing, MSc
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: British Columbia Cancer Agency
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you stop taking chemotherapy agents (drugs used to treat cancer) starting one week before radiation treatment and continuing until one week after the last radiation session.

What data supports the effectiveness of this treatment for metastatic disease?

Research shows that stereotactic ablative radiotherapy (SABR) is a precise and effective treatment for controlling tumors in various organs, with local control rates of about 80%. It may also improve survival in patients with certain types of cancer that have spread to a few other areas, potentially being 'curative' in 20-25% of cases.12345

Is SABR generally safe for treating metastatic disease?

Research shows that SABR (stereotactic ablative radiotherapy) is generally safe for treating various types of metastatic disease, including in the lungs and bones. Studies have evaluated both single and multiple fraction treatments, and while the best dose is still being studied, the safety profile is considered acceptable.46789

How does the SABR treatment for metastatic disease differ from other treatments?

The SABR treatment for metastatic disease is unique because it uses high doses of radiation delivered with precision in either a single session or multiple sessions. This approach can reduce the number of hospital visits and improve patient convenience compared to traditional radiotherapy, while still effectively targeting cancer that has spread to a limited number of sites.3491011

What is the purpose of this trial?

Stereotactic Ablative Radiotherapy (SABR) is a modern RT technique that delivers high doses of radiation to small tumor targets using highly conformal techniques, while trying to avoid healthy tissues and organs. However, SABR treatment requires increased planning, treatment time, cost and potential for higher toxicity due to the higher dose. The purpose of this study is to compare single fraction (SF) SABR vs. multiple fraction (MF) SABR in regards to toxicities, progression-free survival, quality of life (QoL), and cost-effectiveness. In a subset of patients, we will also compare patient QoL, hospitalization rates, and cost-effectiveness between patients who complete QoL questionnaires, record symptoms and receive healthcare provider-guided intervention vs. patients who complete QoL questionnaires only.

Research Team

Olson, Dr. Robert | UNBC

Robert Olson

Principal Investigator

BC Cancer - Prince George

Eligibility Criteria

Adults (18+) with 1-5 oligometastatic or progressing lesions, a controlled primary tumor, and no recent malignant cancers. They must be able to undergo immobilization for SABR treatment, have a life expectancy over 6 months, and complete questionnaires. Excluded are those with serious comorbidities affecting radiotherapy safety, large brain metastases (>3.5 cm), spinal cord compression without resection, pregnant/breastfeeding individuals, or if all disease sites can't be treated.

Inclusion Criteria

I can stay still during treatments.
Able to provide informed consent
Able to complete electronic entry of patient reported outcomes and questionnaires independently or with assistance
See 9 more

Exclusion Criteria

Pregnant or breast feeding
All my cancer spread (metastases) has been surgically removed.
Lesions exceeding maximum size criteria
See 11 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either single fraction or multiple fraction Stereotactic Ablative Radiotherapy (SABR)

6 weeks
Multiple visits for radiation sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment, including quality of life assessments and adverse event monitoring

60 months
Regular follow-up visits at 6 weeks, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months

Quality of Life Assessment

Participants complete quality of life questionnaires and may receive healthcare provider-guided interventions based on symptom screening

Throughout follow-up

Treatment Details

Interventions

  • Multiple fraction SABR
  • QoL reporting alone
  • QoL reporting, symptom screen and healthcare provider intervention
  • Single fraction SABR
Trial Overview The trial compares single fraction versus multiple fraction Stereotactic Ablative Radiotherapy (SABR) in terms of side effects, progression-free survival, quality of life (QoL), and cost-effectiveness. It also assesses the impact on QoL and healthcare costs when patients report symptoms for provider intervention versus only completing QoL questionnaires.
Participant Groups
4Treatment groups
Experimental Treatment
Active Control
Group I: Single fraction SABR (Arm 2)Experimental Treatment1 Intervention
Participants randomized to this arm will receive single fraction SABR
Group II: QoL reporting and healthcare provider (HCP) intervention guided by symptom screen (Arm B)Experimental Treatment1 Intervention
* Patients complete EQ-5D-5L and FACT-G prior to each scheduled FU * Patient complete online adaptive symptom screen with HCP intervention, prior to each scheduled appointment
Group III: Multiple fraction SABR (Arm 1)Active Control1 Intervention
Participants randomized to this arm will receive multiple fraction SABR
Group IV: Patient-reported outcome (PRO) collection : QoL reporting alone (Arm A)Active Control1 Intervention
Participants will complete the EuroQoL-5Dimensions-5levels (EQ-5D-5L) and Functional Assessment of Cancer Therapy-General (FACT-G) prior to each scheduled follow-up (FU).

Find a Clinic Near You

Who Is Running the Clinical Trial?

British Columbia Cancer Agency

Lead Sponsor

Trials
181
Recruited
95,900+

London Regional Cancer Program, Canada

Collaborator

Trials
11
Recruited
1,300+

Tom Baker Cancer Centre

Collaborator

Trials
30
Recruited
8,900+

Princess Margaret Hospital, Canada

Collaborator

Trials
121
Recruited
40,000+

Findings from Research

Stereotactic ablative radiotherapy (SABR) is a highly effective and low-toxicity treatment for metastatic tumors, achieving local control rates of about 80%.
SABR shows promise in treating oligometastatic patients, with pilot studies suggesting it may be 'curative' in 20-25% of cases, especially when combined with systemic therapies.
New concepts and insights into the role of radiation therapy in extracranial metastatic disease.Ricardi, U., Filippi, AR., Franco, P.[2013]
Stereotactic ablative radiotherapy (SABR) demonstrated a high local control rate of 91.2% for skeletal metastases in a study of 22 patients, with a median follow-up of 15.6 months, indicating its effectiveness in managing oligometastatic and oligoprogressive diseases.
The treatment resulted in significant pain control for two-thirds of symptomatic patients, with limited toxicities reported, including only two vertebral fractures and one case of grade 3 esophagitis, suggesting that SABR is a safe option for patients with skeletal metastases.
Utilization of stereotactic ablative radiotherapy in oligometastatic & oligoprogressive skeletal metastases: Results and pattern of failure.Kam, TY., Chan, OSH., Hung, AWM., et al.[2019]
The TROG 13.01/ALTG 13.001 clinical trial is investigating the safety and efficacy of single versus multi-fraction stereotactic ablative body radiotherapy (SABR) for lung tumors in 84 patients with up to three metastases, aiming to determine the best treatment approach for pulmonary oligometastases.
The study will compare a single high dose of 28Gy to a total of 48Gy delivered in four fractions, assessing not only safety but also quality of life, survival rates, and potential cost implications of each treatment method.
A randomised phase II trial of Stereotactic Ablative Fractionated radiotherapy versus Radiosurgery for Oligometastatic Neoplasia to the lung (TROG 13.01 SAFRON II).Siva, S., Kron, T., Bressel, M., et al.[2022]

References

New concepts and insights into the role of radiation therapy in extracranial metastatic disease. [2013]
Stereotactic Ablative Body Radiotherapy for the Treatment of Spinal Oligometastases. [2022]
Total tumor volume as a predictor of survival in patients with multiple oligometastases treated with stereotactic ablative radiotherapy (SABR). [2023]
Comparison of Single-fraction and Multi-fraction Stereotactic Radiotherapy for Patients with 18F-fluorodeoxyglucose Positron Emission Tomography-staged Pulmonary Oligometastases. [2018]
Determining Planning Priorities for SABR for Oligometastatic Disease: A Secondary Analysis of the SABR-COMET Phase II Randomized Trial. [2022]
Stereotactic Ablative Radiation Therapy to All Lesions in Patients With Oligometastatic Cancers: A Phase 1 Dose-Escalation Trial. [2021]
Utilization of stereotactic ablative radiotherapy in oligometastatic & oligoprogressive skeletal metastases: Results and pattern of failure. [2019]
A randomised phase II trial of Stereotactic Ablative Fractionated radiotherapy versus Radiosurgery for Oligometastatic Neoplasia to the lung (TROG 13.01 SAFRON II). [2022]
In Silico Single-Fraction Stereotactic Ablative Radiation Therapy for the Treatment of Thoracic and Abdominal Oligometastatic Disease With Online Adaptive Magnetic Resonance Guidance. [2022]
Population-based phase II trial of stereotactic ablative radiotherapy (SABR) for up to 5 oligometastases: SABR-5. [2023]
Single-Fraction Stereotactic Ablative Body Radiotherapy for Primary and Extracranial Oligometastatic Cancers. [2023]
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