SABR Techniques for Metastatic Disease

Recruiting in Palo Alto (17 mi)

+4 other locations

Overseen byRobert Olson

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: British Columbia Cancer Agency

No Placebo Group

Trial Summary

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.

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

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Exclusion Criteria

Pregnant or breast feeding

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

Lesions exceeding maximum size criteria

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Treatment Details

Interventions

Multiple fraction SABR (Radiation Therapy)
QoL reporting alone (Behavioural Intervention)
QoL reporting, symptom screen and healthcare provider intervention (Behavioural Intervention)
Single fraction SABR (Radiation Therapy)

Trial OverviewThe 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).