Ignite Creation Date:
2025-12-24 @ 11:52 AM
Ignite Modification Date:
2026-01-03 @ 9:35 AM
Study NCT ID:
NCT03398161
Status:
RECRUITING
Last Update Posted:
2025-11-03
First Post:
2018-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultra Low Dose Radiation Therapy in Treating Patients With Mycosis Fungoides
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
Ultra Low Dose Radiation for Local Treatment of Cutaneous Mycosis Fungoides
Status:
RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase II trial studies how well ultra low dose radiation therapy works in treating patients with mycosis fungoides. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving ultra low doses of radiation may help control the disease and reduce side effects compared to treatment with higher doses.
Detailed Description:
PRIMARY OBJECTIVES:
I. To evaluate the efficacy of low dose radiation in the management of cutaneous mycosis fungoides (MF), measured as any local control for each lesion at 12 (+/- 2) weeks after the treatment, in patients with stage IA - IVB cutaneous MF.
SECONDARY OBJECTIVES:
I. To evaluate complete response (CR) rates at 12 (+2) weeks and beyond.
II. To evaluate the persistence of response (CR, partial response \[PR\], stable disease, or progressive disease) in the treated lesion beyond 12 (+2) weeks.
III. To evaluate overall survival.
IV. To evaluate progression free survival.
V. To evaluate patient symptom relief.
VI. To evaluate the toxicity of radiation to the skin.
VII. To assess if number of previous therapies including chemotherapy, targeted therapy, topical therapy, or total skin radiation affects the response.
VIII. To characterize the microbiome of mycosis fungoides patient within both the lesion and unaffected skin.
IX. To characterize shifts in the microbiome that occur after radiation therapy.
OUTLINE:
Patients undergo ultra low dose radiation therapy at the discretion of the treating physician.
After completion of study treatment, patients are followed up at 4-6 and 10-14 weeks, every 3 months for 6-8 months, then every 6-12 months for up to 2 years.
I. To evaluate the efficacy of low dose radiation in the management of cutaneous mycosis fungoides (MF), measured as any local control for each lesion at 12 (+/- 2) weeks after the treatment, in patients with stage IA - IVB cutaneous MF.
SECONDARY OBJECTIVES:
I. To evaluate complete response (CR) rates at 12 (+2) weeks and beyond.
II. To evaluate the persistence of response (CR, partial response \[PR\], stable disease, or progressive disease) in the treated lesion beyond 12 (+2) weeks.
III. To evaluate overall survival.
IV. To evaluate progression free survival.
V. To evaluate patient symptom relief.
VI. To evaluate the toxicity of radiation to the skin.
VII. To assess if number of previous therapies including chemotherapy, targeted therapy, topical therapy, or total skin radiation affects the response.
VIII. To characterize the microbiome of mycosis fungoides patient within both the lesion and unaffected skin.
IX. To characterize shifts in the microbiome that occur after radiation therapy.
OUTLINE:
Patients undergo ultra low dose radiation therapy at the discretion of the treating physician.
After completion of study treatment, patients are followed up at 4-6 and 10-14 weeks, every 3 months for 6-8 months, then every 6-12 months for up to 2 years.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2018-00861 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| 2017-0276 | OTHER | M D Anderson Cancer Center | View | |
| P30CA016672 | NIH | None | https://reporter.nih.gov/quic… | View |