ARREST - A Phase I Study of SABR for Poly-metastatic Disease

NCT04530513 | Completed DMC

• 2 other identifiers: ARRESTReDA #10401
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

Stereotactic ablative radiotherapy (SABR) is a new radiation treatment that delivers high-dose, precise radiation to small areas in the body. This new technique can potentially allow radiation treatments to be focused more precisely, and be delivered more accurately than with older treatments. This improvement could help by reducing side effects overall (through radiation exposure to a smaller area of the body over a shorter time period), and by improving the chance of controlling the cancer by more precisely treating the cancer and by giving higher doses of radiation. SABR is considered a standard treatment for some lung cancers, and selected cancers that have spread to the brain. Ongoing studies are evaluating the use of SABR for treating people with up to 10 sites of cancer in the body, but its safety and value for treating patients with poly-metastatic cancer (more than 10 sites of cancer) is not yet known. The purpose of this study is to determine the safety of using SABR to treat people with poly-metastatic disease. To our knowledge, this is the first time that SABR will be tested in people who have poly-metastatic disease.

Conditions

Metastatic Cancer

Keywords

Stereotatic ablative radiotherapy; Poly-Metastatic Cancer

Outcome Measures

Primary Outcomes (1)

• Maximally Tolerated Dose of Stereotactic Radiotherapy

  In determining the maximally tolerated dose (MTD) grade 5 toxicity (patient death) attributable to treatment, any Grade 4 toxicity among the Hematologic, Hepatobiliary or Respiratory domains, more than 3 instances of Grade 3-4 toxicities occurring within 6 weeks of treatment will be taken into consideration. This is based on the Common Terminology Criteria for Adverse Events (CTCAE) grading system. Additionally, in determining the MTD, the feasibility of successfully planning and treating at a given dose level will be considered.

  2 years and 3 months

Secondary Outcomes (3)

• Quality of life at 6 weeks post radiotherapy as measured by the Functional Assessment of Cancer Therapy - General (FACT-G)

  2 years and 3 months

• Quality of life at 6 weeks post radiotherapy as measured by the EuroQOL Group EQ-5D-5L

  2 years and 3 months

• Progression free survival post radiotherapy

  4 years

Study Arms (5)

Dose Level 1

EXPERIMENTAL

Radiation: Stereotactic ablative radiotherapy - Level 1

Dose Level 2

EXPERIMENTAL

Radiation: Stereotactic ablative radiotherapy - Level 2

Dose Level 3

EXPERIMENTAL

Radiation: Stereotactic ablative radiotherapy - Level 3

Dose Level 4

EXPERIMENTAL

Radiation: Stereotactic ablative radiotherapy - Level 4

De-escalation Level

EXPERIMENTAL

Radiation: Stereotactic ablative radiotherapy - De-escalation Level

Interventions

Stereotactic ablative radiotherapy - Level 1 RADIATION

6Gy x 2 fractions to all sites in 2 weeks

Dose Level 1

Stereotactic ablative radiotherapy - Level 2 RADIATION

6Gy x 3 fractions to all sites in 3 weeks

Dose Level 2

Stereotactic ablative radiotherapy - Level 3 RADIATION

6Gy x 4 fractions to all sites in 4 weeks

Dose Level 3

Stereotactic ablative radiotherapy - Level 4 RADIATION

6Gy x 5 fractions to all sites in 5 weeks

Dose Level 4

Stereotactic ablative radiotherapy - De-escalation Level RADIATION

6Gy x 1 fraction to all sites in 1 week

De-escalation Level

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 or older
• Willing and able to provide informed consent
• ECOG 0-2
• Life expectancy greater than 3 months
• Histologically confirmed malignancy with metastatic disease detected on imaging. A biopsy of a metastatic site is preferred, but not required.
• Staging/Re-staging within 6 weeks prior to enrollment:
• Brain: Computerized Tomography (CT) or Magnetic Resonance Imaging (MRI) for tumor sites with propensity for brain metastasis. All patients with brain metastases (at enrollment or previously treated) require an MRI of the brain.
• Body: CT neck/chest/abdomen/pelvis and bone scan required. This may be replaced with a Positron Emission Tomography (PET)/CT (18-Fluorodeoxyglucose \[FDG\] or Prostate Specific Membrane Antigen \[PSMA\]) except for tumors where FDG uptake is not expected.
• Spine: MRI of the spine is not mandatory for enrollment.
• Presence of poly-metastatic disease, defined as total number of targets greater than 10
• No standard of care systemic therapy option exists for the patient, the patient refuses further standard systemic therapy, or there is no intent to deliver systemic therapy for 3 months after enrollment.
• At the discretion of the treating oncologist, it is believed that all sites of disease can be safely treated for enrollment on study.

You may not qualify if:

• Serious medical comorbidities precluding radiotherapy. These include interstitial lung disease in patients requiring thoracic radiation, Crohn's disease in patients where the Gastrointestinal (GI) tract will receive radiotherapy, ulcerative colitis where the bowel will receive radiotherapy or connective tissue disorders such as lupus or scleroderma.
• For patients with liver metastases, moderate/severe liver dysfunction
• Inadequate baseline bone marrow function (i.e. symptomatic anemia, neutropenia and/or thrombocytopenia which may interfere with the ability to deliver radiation).
• Chronic kidney dysfunction Estimated Glomerular Filtration Rate (eGFR) less than 30 where a significant dose of radiotherapy is expected to be delivered to the kidney.
• Substantial overlap with a previously treated radiation volume. Prior radiotherapy in general is allowed, as long as the composite plan meets dose constraints herein. For patients treated with radiation previously, biological effective dose calculations should be used to equate previous doses to the tolerance doses.
• Prior treatment with systemic radiopharmaceuticals (i.e. Radium 223 or Lutetium 177)
• More than 50 metastases (count excluding equivocal lesions less than 5mm in size)
• Any single metastasis greater than 5 cm in size. This is a firm cut-off.
• Any brain metastasis greater than 3 cm in size or a total volume of brain metastases greater than 30 cc. This is a firm cut-off.
• Central Nervous System (CNS) only disease
• Metastasis in the brainstem.
• Inability to treat all sites of disease, which may include:
• Disease involving any of the following: GI tract (including esophagus, stomach, small or large bowel), mesenteric lymph nodes, and/or skin
• Diffuse or "miliary" metastatic disease of brain, bone, lung, liver or other sites (i.e. lymphangitic spread, malignant pleural effusion/ascites, peritoneal disease, leptomeningeal metastases) where it would be impossible to deliver radiotherapy at the intended dose level
• Any evidence of epidural disease on any baseline imaging.

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• Ontario Institute for Cancer Research: collaborator

Study Sites (1)

London Health Sciences Centre - London Regional Cancer Program

London, Ontario, N6A 5W9, Canada

Location

Related Publications (2)

• Corkum MT, Fakir H, Palma DA, Nguyen T, Bauman GS. Can Polymetastatic Disease Be ARRESTed Using SABR? A Dosimetric Feasibility Study to Inform Development of a Phase 1 Trial. Adv Radiat Oncol. 2021 Jun 5;6(5):100734. doi: 10.1016/j.adro.2021.100734. eCollection 2021 Sep-Oct.

  PMID: 34278053 DERIVED

• Bauman GS, Corkum MT, Fakir H, Nguyen TK, Palma DA. Ablative radiation therapy to restrain everything safely treatable (ARREST): study protocol for a phase I trial treating polymetastatic cancer with stereotactic radiotherapy. BMC Cancer. 2021 Apr 14;21(1):405. doi: 10.1186/s12885-021-08020-2.

  PMID: 33853550 DERIVED

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Glenn Bauman, MD

  London Health Sciences Centre, Lawson Health Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Dose Escalation Study

Study Record Dates

• First Submitted: August 25, 2020
• First Posted: August 28, 2020
• Study Start: November 17, 2020
• Primary Completion: June 26, 2023
• Study Completion: June 15, 2025
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)