ARREST - A Phase I Study of SABR for Poly-metastatic Disease
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|ClinicalTrials.gov Identifier: NCT04530513|
Recruitment Status : Recruiting
First Posted : August 28, 2020
Last Update Posted : November 19, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Cancer||Radiation: Stereotactic ablative radiotherapy - Level 1 Radiation: Stereotactic ablative radiotherapy - Level 2 Radiation: Stereotactic ablative radiotherapy - Level 3 Radiation: Stereotactic ablative radiotherapy - Level 4 Radiation: Stereotactic ablative radiotherapy - De-escalation Level||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||Dose Escalation Study|
|Masking:||None (Open Label)|
|Official Title:||ARREST - A Phase I Study of SABR for Poly-metastatic Disease|
|Actual Study Start Date :||November 17, 2020|
|Estimated Primary Completion Date :||February 15, 2023|
|Estimated Study Completion Date :||November 15, 2024|
|Experimental: Dose Level 1||
Radiation: Stereotactic ablative radiotherapy - Level 1
6Gy x 2 fractions to all sites in 2 weeks
|Experimental: Dose Level 2||
Radiation: Stereotactic ablative radiotherapy - Level 2
6Gy x 3 fractions to all sites in 3 weeks
|Experimental: Dose Level 3||
Radiation: Stereotactic ablative radiotherapy - Level 3
6Gy x 4 fractions to all sites in 4 weeks
|Experimental: Dose Level 4||
Radiation: Stereotactic ablative radiotherapy - Level 4
6Gy x 5 fractions to all sites in 5 weeks
|Experimental: De-escalation Level||
Radiation: Stereotactic ablative radiotherapy - De-escalation Level
6Gy x 1 fraction to all sites in 1 week
- Maximally Tolerated Dose of Stereotactic Radiotherapy [ Time Frame: 2 years and 3 months ]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.
- Quality of life at 6 weeks post radiotherapy as measured by the Functional Assessment of Cancer Therapy - General (FACT-G) [ Time Frame: 2 years and 3 months ]The Functional Assessment of Cancer Therapy - General (FACT-G ) is a standardized questionnaire used to measure quality of life. The questionnaire consists of 4 scales measuring 27 items in total. Categories of the 4 scales are: physical well-being, social/family well-being, emotional well-being, and functional well-being. The score for each item in the scale ranges from 0 to 4, where 0 is not at all and 4 is very much. The scores from each scale are added up, and can be combined to provide a total score.
- Quality of life at 6 weeks post radiotherapy as measured by the EuroQOL Group EQ-5D-5L [ Time Frame: 2 years and 3 months ]The EQ-5D-5L is a standardized questionnaire used to measure quality of life and health. The first section includes 5 categories: mobility, self-care, usual activities (e.g. work, family), pain/discomfort, and anxiety/depression. Each category contains 5 statements ranging from no problems to extreme problems, where no problems is assigned a code of 1 and extreme problems is assigned a code of 5. Participants are asked to select the statement that best describes their health that day. No score is generated, rather a 5 digit code is generated based on the response provided, which can then be combined into a data set and interpreted in a variety of ways. The second section includes a 20 cm analogue scale from 0 to 100, where 100 is the best health ever imagined and 0 is the worst health imagined. The participant will mark a score on the scale representing the state of their health on that day.
- Progression free survival post radiotherapy [ Time Frame: 4 years ]Time from randomization to disease progression at any site or death.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04530513
|Contact: Glenn Bauman, MD||519-685-8650||Glenn.Bauman@lhsc.on.ca|
|Contact: David Palma, MD, PhD||519-685-8650||David.Palma@lhsc.on.ca|
|London Health Sciences Centre - London Regional Cancer Program||Recruiting|
|London, Ontario, Canada, N6A 5W9|
|Contact: Glenn Bauman, MD 519-685-8650 Glenn.Bauman@lhsc.on.ca|
|Principal Investigator:||Glenn Bauman, MD||London Health Sciences Centre, Lawson Health Research Institute|