FLASH Pilot Phase 1 Safety Study

Inclusion criteria

• Histologic proof of cutaneous lymphoma.
• The cutaneous lymphoma is not planned to be treated with definitive, higher dose radiotherapy therapy.
• 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.
• No prior history of radiotherapy to the site of planned treatment.
• Patient agrees to discontinue topical therapy, including steroid creams or chemotherapy agents, to the index lesion 4 weeks prior to the radiation treatment.
• Participant must be capable of providing informed consent or has an acceptable surrogate capable of providing consent on behalf of the participant.
• Adults at least 18 years of age
• Eastern Cooperative Oncology Group performance status of <3.
• 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.
• WOCBP who are sexually active must agree at study entry to use adequate methods of contraception during treatment.

Exclusion criteria

• Prior radiotherapy to the site of treatment.
• Index lesion UHDR treatment field is <5cm from the field edge of a synchronously treated CONV lesion.
• Patient receiving prescribed hormonal therapies.
• Patients with known NCI CTCAE V5.0 grade 3 or higher active systemic or cutaneous viral, bacterial, or fungal infection.
• 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.
• Patients with dementia or altered mental status that would preclude understanding and rendering of informed consent process.