Cutaneous Lymphoma
Conditions
Keywords
Conventional radiotherapy, Ultra-high dose rate (UDHR) radiotherapy, electron FLASH
Brief summary
The primary purpose of this research trial is to study the safety of electron FLASH treatment for cutaneous lymphoma lesions. In addition, investigators will confirm the accuracy of dose and dose rate delivery of electron FLASH therapy using on-patient dosimetry measurements in combination with FAST camera imaging. Researchers will also determine the response rates of cutaneous lymphomas treated with a low radiation dose in a single fraction using electron UHDR treatments, followed by an assessment of radiation related skin toxicity.
Interventions
DEVICEIntraOp Mobetron UHDR
The Mobetron UDHR System provides electrons for precision radiotherapy of lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated. The FLASH enabled Mobetron System is intended to deliver electron FLASH radiotherapy to participants with cutaneous lymphoma lesions located in extremities.
RADIATIONLinac
Conventional radiotherapy
Sponsors
Lesley A. Jarvis
Dartmouth College
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Intervention model description
This is a prospective, single institution safety study of electron FLASH radiation treatment (RT) for participants with cutaneous lymphomas. The primary study objective is to determine the safety and characterize the toxicity profile of electron FLASH treatment to participants receiving palliative radiotherapy for cutaneous lymphomas. A maximum of 10 participants will be enrolled. Participants with more than one cutaneous lesion requiring treatment will have one lesion treated with electron FLASH therapy. The remainder of the lesions will be treated with conventional electron treatment, allowing such participants to serve as their own internal control. The duration of an individual participant's time in the study will include the simulation and treatment planning duration (\<4 weeks). Participants will be clinically assessed for 5 years after completion of the radiation treatment.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Histologic proof of cutaneous lymphoma. 2. The cutaneous lymphoma is not planned to be treated with definitive, higher dose radiotherapy therapy. 3. Participant is planned to receive a course of palliative radiation therapy at DHMC for a cutaneous lymphomas lesion located on an extremity (see appendix A) that can be encompassed in a field size no larger than 7.5 cm in diameter. 4. No prior history of radiotherapy to the site of planned treatment. 5. Patient agrees to discontinue topical therapy, including steroid creams or chemotherapy agents, to the index lesion 4 weeks prior to the radiation treatment. 6. Participant must be capable of providing informed consent or has an acceptable surrogate capable of providing consent on behalf of the participant. 7. Adults at least 18 years of age 8. Eastern Cooperative Oncology Group performance status of \<3. 9. Women of childbearing potential (WOCBP): Premenopausal females who had at least one menstrual cycle in the past 12-months and capable to become pregnant, must have a negative serum beta-HCG pregnancy test result within seven days prior to start of treatment. 10. WOCBP who are sexually active must agree at study entry to use adequate methods of contraception during treatment.
Exclusion criteria
1. Prior radiotherapy to the site of treatment. 2. Index lesion UHDR treatment field is \<5cm from the field edge of a synchronously treated CONV lesion. 3. Patient receiving prescribed hormonal therapies. 4. Patients with known NCI CTCAE V5.0 grade 3 or higher active systemic or cutaneous viral, bacterial, or fungal infection. 5. Patients with any serious underlying medical condition that would impair their ability to receive or tolerate the planned treatment and/or comply with study protocol. 6. Patients with dementia or altered mental status that would preclude understanding and rendering of informed consent process.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and toxicity profile characterization of electron FLASH treatment | 5 years | To study the safety and characterize the toxicity profile of electron FLASH treatment, a clinical evaluation of all lesions treated will be performed on all grade 3 or higher toxicities according to the Common Terminology Criteria for Adverse Effects (CTCAE) version 6.0. |
Contacts
CONTACTLesley A Jarvis, MD
PRINCIPAL_INVESTIGATORLesley A Jarvis, MD
Dartmouth-Hitchcock Medical Center
Outcome results
None listed