FLASH Radiotherapy for Bone Metastases
(FAST-02 Trial)
Recruiting in Palo Alto (17 mi)
Overseen byJohn Breneman, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Varian, a Siemens Healthineers Company
Must not be taking: Cytotoxic chemotherapy
Disqualifiers: More than 3 metastases, Metal implants, Symptomatic pneumonitis, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?The purpose of this study is to assess toxicities of FLASH radiotherapy treatment and pain relief in subjects with painful thoracic bone metastases. FLASH radiotherapy is radiation treatment delivered at ultra-high dose rates compared to conventional radiation treatment.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have received certain chemotherapy or systemic therapy within 2 weeks before or 1 week after the planned radiation treatment.
What data supports the effectiveness of the treatment FLASH Radiotherapy for Bone Metastases?
Radiation therapy is known to effectively relieve pain and improve the quality of life for patients with bone metastases, and advanced techniques like stereotactic body radiation therapy (SBRT) and intensity-modulated radiation therapy (IMRT) have shown potential for excellent tumor control with minimal side effects.
12345Is FLASH Radiotherapy safe for humans?
FLASH Radiotherapy has been shown in preclinical studies to reduce damage to healthy tissues compared to traditional radiation therapy, while still effectively treating tumors. However, most of the research has been done in animal models, and clinical application in humans is still very limited.
678910Eligibility Criteria
Adults over 18 with 1-3 painful bone metastases in the thorax, expected to live more than 6 months, and can follow the study plan. Excluded are those with metal implants in the treatment area, prior radiation or therapy that affects tissue response to radiation within specific timeframes before/after treatment, pregnant or nursing women, and certain medical conditions.Inclusion Criteria
Life expectancy >6 months (in the judgement of the investigator)
I am 18 years old or older.
My bone cancer can be targeted with a specific size of radiation treatment.
+4 more
Exclusion Criteria
Patients with pacemakers or other implanted devices at risk of malfunction during radiotherapy
I haven't had any local treatments in the last 2 weeks that could affect pain assessment.
I cannot receive chest radiation due to health reasons.
+11 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive FLASH radiotherapy for painful bone metastases in the thorax
1 day
1 visit (in-person)
Follow-up
Participants are monitored for pain relief and toxicities post-treatment
6 months
Participant Groups
The trial is testing FLASH Radiotherapy for pain relief and safety in patients with painful bone metastases in the chest area. This new type of radiotherapy is given at much faster rates than conventional treatments.
1Treatment groups
Experimental Treatment
Group I: FLASH radiotherapy for painful bone metastasis(-es)Experimental Treatment1 Intervention
FLASH radiotherapy is radiation treatment delivered at ultra-high dose rates compared to conventional radiation treatment.
FLASH Radiotherapy is already approved in United States for the following indications:
🇺🇸 Approved in United States as FLASH Radiotherapy for:
- Symptomatic Bone Metastases
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Cincinnati Children's Hospital Medical CenterCincinnati, OH
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Who Is Running the Clinical Trial?
Varian, a Siemens Healthineers CompanyLead Sponsor
References
A randomized trial of three single-dose radiation therapy regimens in the treatment of metastatic bone pain. [2019]To investigate efficacy of three single dose radiation therapy (RT) regimens in the treatment of painful bone metastasis.
To What Extent Does Radiotherapy Improve the Quality of Life of Patients With Bone Metastasis?: A Prospective, Single-Institutional Study. [2019]Radiation therapy (RT) is an effective method of palliating painful bone metastases and improves the quality of life (QoL) of these patients. The purpose of this trial is 2-fold: to quantify the impact of RT in the QoL of patients with bone metastasis and to compare the QoL results between the most used schemes of RT at our Centre.
Incidence and treatment patterns of complicated bone metastases in a population-based radiotherapy program. [2018]There is abundant evidence in support of single fraction (SF) radiation therapy (RT) for uncomplicated bone metastases (BoM). We sought to determine the proportion of BoM that is complicated in a population-based RT program in order to act as a potential guide for assessing SFRT utilization rates.
STAT RAD: Prospective Dose Escalation Clinical Trial of Single Fraction Scan-Plan-QA-Treat Stereotactic Body Radiation Therapy for Painful Osseous Metastases. [2022]Radiation therapy is a well-established treatment for symptomatic bone metastases. Despite continued advances in both planning techniques and treatment delivery, the standard workflow has remained relatively unchanged, often requiring 1 to 3 weeks and resulting in patient inconvenience and delayed palliation. We developed an expedited method wherein computed tomography simulation, treatment planning, quality assurance, and treatment delivery are performed in 1 day. This prospective pilot clinical trial evaluates the safety, efficacy, and patient satisfaction of this rapid workflow.
The current status and future of radiotherapy for spinal bone metastases. [2018]The management of spinal bone metastases is complex. In this review, the efficacy, methodology, and utilization of radiotherapy (RT) for spinal bone metastases are discussed. A number of randomized trials have evaluated the efficacy of 8 Gy, single-fraction RT for the palliation of painful bone metastases. However, RT for metastatic spinal cord compression has not been evaluated with respect to its optimal dose, palliative potential, or its ability to improve motor function. Two highly sophisticated RT techniques - stereotactic body RT (SBRT) and intensity-modulated RT (IMRT) - have recently been adapted for the treatment of spinal bone metastases, and both have the potential to achieve excellent control while minimizing acute and late toxicity. SBRT and IMRT are particularly well suited for the treatment of spinal bone metastases when they are localized or require re-irradiation, and may provide superior tumor control. Predicting the prognosis of patients with bone metastases and assessing spinal instability are both important when selecting the optimal RT method and deciding whether to perform surgery. The proper care of spinal bone metastases patients requires an interdisciplinary treatment approach.
Key changes in the future clinical application of ultra-high dose rate radiotherapy. [2023]Ultra-high dose rate radiotherapy (FLASH-RT) is an external beam radiotherapy strategy that uses an extremely high dose rate (≥40 Gy/s). Compared with conventional dose rate radiotherapy (≤0.1 Gy/s), the main advantage of FLASH-RT is that it can reduce damage of organs at risk surrounding the cancer and retain the anti-tumor effect. An important feature of FLASH-RT is that an extremely high dose rate leads to an extremely short treatment time; therefore, in clinical applications, the steps of radiotherapy may need to be adjusted. In this review, we discuss the selection of indications, simulations, target delineation, selection of radiotherapy technologies, and treatment plan evaluation for FLASH-RT to provide a theoretical basis for future research.
FLASH radiotherapy with photon beams. [2022]Ultra-high-dose rate "FLASH" radiotherapy (FLASH-RT) has been shown to drastically reduce normal tissue toxicities while being as efficacious as conventional dose rate radiotherapy to treat tumors. A large number of preclinical studies describing this so-called FLASH effect have led to the clinical translation of FLASH-RT using ultra-high-dose rate electron and proton beams. Although the vast majority of radiation therapy treatments are delivered using X-rays, few preclinical data using ultra-high-dose rate X-ray irradiation have been published. This review focuses on different methods that can be used to generate ultra-high-dose rate X-rays and their beam characteristics along with their effect on the biological tissues and the perspectives for the development of FLASH-RT with X-rays.
FLASH radiotherapy: an emerging approach in radiation therapy. [2022]FLASH radiotherapy (RT) is a technique involving the delivery of ultra-high dose rate radiation to the target. FLASH-RT has been shown to reduce radiation-induced toxicity in healthy tissues without compromising the anti-cancer effects of treatment compared to conventional radiation therapy. In the present article, we review the published data on FLASH-RT and discuss the current state of knowledge of this novel approach. We also highlight the technological constraints and complexity of FLASH-RT and describe the physics underlying this modality, particularly how technology supports energy transfer by ionising radiation (e.g., beam on/off sequence, pulse-energy load, intervals). We emphasise that current preclinical experience is mostly based on FLASH electrons and that clinical application of FLASH-RT is very limited. The incorporation of FLASH-RT into routine clinical radiotherapy will require the development of devices capable of producing FLASH photon beams.
FLASH radiotherapy: What, how and why? [2023]Ultra-high dose rate (FLASH) radiotherapy is a new way of treating tumours caused by cancer. Higher doses of radiotherapy are associated with trauma to the healthy tissue surrounding the tumour, whereas FLASH radiotherapy demonstrates a sparing effect of the healthy tissues without compromising the anti-tumour action. Dr Kristoffer Petersson at the Oxford Institute for Radiation Oncology, University of Oxford, along with collaborators Joseph D. Wilson, Ester M. Hammond and Geoff S. Higgins, review the available data on FLASH radiotherapy and its clinical potential in the treatment of cancer.
Ultra-high dose rate FLASH radiation therapy for cancer. [2023]Conformality has been a key requirement in radiation therapy for cancer to minimize normal tissue toxicity while maintaining tumor control. Since 2014, there has been great interest in ultra-high dose rate (UHDR), "FLASH," radiation therapy to enhance this therapeutic window. In multiple pre-clinical studies, it was seen that normal tissue demonstrated less damage due to radiation of various modalities when the same dose was delivered at ultra-high mean dose rates exceeding ∼40 Gy/s while tumor control remained indifferent to changes in dose rate. The scientific community has large-scale interdisciplinary studies to investigate this potentially breakthrough technique to enhance treatment options for cancer. FLASH studies have been performed using a number of modalities and delivery techniques for many pre-clinical models. There have been several studies reporting evidence of the FLASH effect as well as technological developments relating to UHDR studies. There is sustained interest and motivation for this topic as well as many questions that are yet to be answered. We provide a short overview to highlight some of the major work and challenges to advance research in FLASH radiotherapy.
Stereotactic body radiotherapy in the management of painful bone metastases. [2008]More than 100,000 new cases of bone metastases are diagnosed each year, and they present an important clinical problem. They cause significant morbidity and quality-of-life issues in cancer patients. Conventional external-beam radiotherapy is currently the most common method to treat these metastases, with several randomized controlled trials showing no difference in effectiveness between multiple- and single-dosing treatment regimens. A newer technology to treat bone metastases is stereotactic body radiotherapy (SBRT), a radiation delivery method that allows for a large ablative dose to be accurately given to the target over one to a few fractions. This review details the role of SBRT in painful bone metastases, primarily in the vertebral column, but in other bony sites as well, its unique advantages and disadvantages, and its role in the treatment of tumors traditionally deemed radioresistant. Toxicity to surrounding normal tissues and patterns of local failures are also addressed.
Intensity-modulated radiotherapy with integrated-boost in patients with bone metastasis of the spine: study protocol for a randomized controlled trial. [2023]Stereotactic body radiation therapy (SBRT) using intensity-modulated radiotherapy (IMRT) with dose escalation by simultaneous integrated boost (SIB) can be a safe modality for treating spinal bone metastases with enhanced targeting accuracy and improve local tumor control.