SABR Techniques for Metastatic Disease

Recruiting at 10 trial locations

Overseen By Jordanna Laing, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Robert Olson

Must not be taking: Chemotherapy agents

Disqualifiers: Uncontrolled cancer, Serious comorbidities, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 6 weeks

598 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two methods of delivering high-dose radiation treatment, known as Stereotactic Ablative Radiotherapy (SABR), for individuals with a few metastatic cancer spots. The aim is to determine whether a single large dose (single fraction) or multiple smaller doses (multiple fraction) is more effective in terms of side effects, cancer control, and overall cost. Some participants will also assist researchers in understanding how symptom tracking and medical advice impact quality of life and healthcare expenses. Suitable candidates have 1-5 metastatic cancer spots, have had their primary tumor controlled for at least 3 months, and can use electronic devices to complete surveys. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance future cancer treatments.

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 prior data suggests that SABR techniques are safe for treating metastatic disease?

Research has shown that both single session (SF) and multiple session (MF) Stereotactic Ablative Radiotherapy (SABR) treatments are generally well-tolerated by patients. A study comparing the safety of these methods found similar rates of serious side effects, indicating neither method is significantly more harmful than the other. This suggests that both SF and MF SABR are equally safe options.

For SF SABR, another study with a follow-up of over three years showed good survival rates, indicating that the treatment is effective and does not cause severe long-term side effects. Similarly, MF SABR has demonstrated comparable safety, with no significant differences in serious side effects compared to SF SABR, according to another study.

These findings encourage those considering SABR as a treatment option. Both SF and MF SABR have been thoroughly studied and have shown consistent safety records. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the SABR techniques for metastatic disease because they offer a potential improvement over traditional radiation therapy. Unlike conventional methods that typically involve numerous sessions over several weeks, the study is exploring the effectiveness of single and multiple fraction Stereotactic Ablative Radiotherapy (SABR), which can deliver precise, high-dose radiation in fewer sessions. This could lead to more convenient treatment schedules and less time in therapy for patients. Moreover, the trial is investigating how patient-reported outcomes and symptom-based HCP interventions can optimize care, potentially leading to better quality of life and personalized treatment adjustments.

What evidence suggests that this trial's treatments could be effective for metastatic disease?

This trial will compare different SABR techniques for metastatic disease. Research has shown that both single fraction (SF) and multiple fraction (MF) targeted radiation therapy effectively treat cancer that has spread. One study found that SF therapy controlled cancer in 91% of patients after one year when doses exceeded 20 Gy. Another study reported a 93% survival rate after one year with MF therapy. Participants in this trial will be randomized to receive either SF or MF SABR. Both treatments yield similar results in terms of safety, effectiveness, and survival. SF therapy is more convenient and uses fewer resources, while MF therapy has a longer history of use. Each option has its advantages and disadvantages, but both are promising for treating metastatic cancer. ^{5 6 7 8 9}

Who Is on the Research Team?

Robert Olson

Principal Investigator

BC Cancer - Prince George

Are You a Good Fit for This Trial?

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

Exclusion Criteria

Pregnant or breast feeding

All my cancer spread (metastases) has been surgically removed.

I need surgery to relieve pressure in my brain from cancer.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Single fraction SABR (Arm 2) Experimental Treatment 1 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 Treatment 1 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 Control 1 Intervention

Participants randomized to this arm will receive multiple fraction SABR

Group IV: Patient-reported outcome (PRO) collection : QoL reporting alone (Arm A) Active Control 1 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).

Who Is Running the Clinical Trial?

Robert Olson

Lead Sponsor

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+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New concepts and insights into the role of radiation therapy in extracranial metastatic disease. Ricardi, U., Filippi, AR., Franco, P.[2013]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8404145/

Single-Fraction vs Multifraction Stereotactic Ablative Body ... 44). Median OS was not reached in either arm, with OS estimates in the multifraction arm of 93% (95% CI, 80%-98%) at 1 year and 67% (95% CI, 48 ...

2. bmccancer.biomedcentral.com bmccancer.biomedcentral.com/articles/10.1186/s12885-024-11905-7

SIMPLIFY-SABR-COMET | BMC Cancer Radiotherapy delivery regimens can vary between a single fraction (SF) and multiple fractions (MF) given daily for up to several weeks ...

3. ascopubs.org ascopubs.org/doi/10.1200/JCO.23.00150

Long-Term Outcomes of TROG 13.01 SAFRON II ... The study found no differences in safety, efficacy, systemic immunogenicity, or survival between arms, with single-fraction SABR picked as the winner on the ...

4. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK603676/

Stereotactic Ablative Radiotherapy for the Treatment of ... - NCBI The current clinical evidence suggests that SABR plus SOC may offer survival benefits for patients with oligometastatic cancer compared to SOC alone. However, ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0360301620346587

Long-Term Results of a Phase 1 Dose-Escalation Trial and ... Conclusions. For selected patients with liver metastases, single-fraction SABR at doses of 35 and 40 Gy was safe and well-tolerated, and shows excellent ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10838428/

Single vs. multiple fraction non-inferiority trial of stereotactic ... Single vs. multiple fraction non-inferiority trial of stereotactic ablative radiotherapy for the comprehensive treatment of oligo-metastases/progression.

7. jamanetwork.com jamanetwork.com/journals/jamaoncology/fullarticle/2783660

Single-Fraction vs Multifraction Stereotactic Ablative Body ... This randomized clinical trial of patients with pulmonary oligometastases compares the safety profiles, defined by the rate of high-grade.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9600736/

Outcomes of High-Dose Stereotactic Ablative Radiotherapy ... This study retrospectively investigated the efficacy and prognostic factors of high-dose SABR for oligometastatic RCC patients.

9. sciencedirect.com sciencedirect.com/science/article/pii/S0360301623059928

Outcomes of Targeted Therapy Plus Immunotherapy and ... The median follow-up was 12 months. There were 75% of patients with intermediate-risk and 18% with favorable-risk disease. 61% of the patients were ...