ConformalFLASH Irradiation for Head and Neck Cancer
(C-FLASH-01 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new type of radiation treatment, called ConformalFLASH, for people with head and neck cancer who have already received radiation and cannot undergo surgery. The goal is to determine if this method can safely deliver high doses of radiation to the cancer. Suitable candidates for this trial have head and neck cancer, have previously undergone radiation, and are unable to have surgery. As an unphased trial, it offers patients the chance to explore innovative treatment options not yet widely available.
What prior data suggests that ConformalFLASH irradiation is safe for head and neck cancer patients?
Research is exploring a new method called ConformalFLASH for treating head and neck cancer with radiation. This method uses very high doses of radiation to target tumors more precisely. Although direct information about its safety in humans is limited, early studies suggest it could be as safe as other types of proton therapy.
Proton therapy is generally well-tolerated because it delivers radiation more accurately, protecting healthy tissues around the cancer. Researchers hope that ConformalFLASH will be just as safe or even safer, potentially reducing side effects compared to traditional radiation methods. However, as this is a new treatment, ongoing studies are needed to confirm these early results.12345Why are researchers excited about this trial?
ConformalFLASH irradiation is unique because it delivers radiation in ultra-fast bursts, which is a departure from the continuous or slower radiation methods typically used for head and neck cancer. This rapid delivery is thought to minimize damage to healthy tissues while effectively targeting cancer cells, potentially reducing side effects associated with traditional radiation therapy. Researchers are excited about this approach because it could lead to more comfortable treatments with fewer adverse effects and better overall outcomes for patients.
What evidence suggests that ConformalFLASH irradiation is effective for head and neck cancer?
Research has shown that ultra-high dose-rate proton therapy, such as ConformalFLASH, might benefit people with head and neck cancer who require additional radiation treatment. ConformalFLASH, the treatment under study in this trial, delivers higher doses to cancer cells while potentially causing less harm to healthy tissues. Early results from similar treatments suggest this method could more precisely and effectively target tumors, which is crucial in complex areas like the head and neck. Although specific data on ConformalFLASH remains limited, it aims to improve upon results from other advanced radiation techniques, offering hope for those who cannot undergo surgery.678910
Who Is on the Research Team?
Alexander Lin, MD
Principal Investigator
University of Pennsylvania
Are You a Good Fit for This Trial?
This trial is for adults with head and neck cancer who have already received significant radiation to the area, cannot or do not want surgery, are in reasonably good health, and can give informed consent. Participants must have a life expectancy of over 12 weeks.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive ConformalFLASH irradiation consisting of five fractions delivered over approximately 1.5 to 2 weeks
Follow-up
Participants are monitored for acute and late toxicities, local and regional control, metastasis-free survival, overall survival, and patient-reported quality of life
What Are the Treatments Tested in This Trial?
Interventions
- ConformalFLASH irradiation
Trial Overview
The study is testing an ultra-high dose-rate proton therapy called ConformalFLASH for people needing repeat radiation treatment for head and neck cancer. It aims to see if this new method is practical compared to standard re-irradiation techniques.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
ConformalFLASH irradiation
Find a Clinic Near You
Who Is Running the Clinical Trial?
IBA Proton Therapy, Inc.
Lead Sponsor
University of Pennsylvania
Collaborator
Citations
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We presented these planning results on 15 Head & Neck (H&N) re-irradiation patients with variable tumor locations in neck, mucosal or salivary gland. We showed ...
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The study is testing an ultra-high dose-rate proton therapy called ConformalFLASH for people needing repeat radiation treatment for head and neck cancer. It ...
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In this work, we conducted a treatment planning study for head and neck (H&N) re-irradiation patients using a research-version of a commercial TPS paired with ...
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insideprecisionmedicine.com
insideprecisionmedicine.com/topics/oncology/flash-proton-therapy-could-help-patients-with-head-and-neck-cancer/FLASH Proton Therapy Could Help Patients with Head and ...
Researchers have started a Phase I trial of FLASH proton therapy for head and neck cancer patients, with the aim of reducing side effects.
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