Ultra Low Dose Radiation Therapy in Treating Patients With Mycosis Fungoides
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with pathologically confirmed MF with cutaneous involvement.
Patients must have clinically measurable disease of at least 1 lesion on physical (skin) exam.
If a patient has a prior pathological diagnosis of MF and is clinically diagnosed with a new lesion, the new lesion is eligible for enrollment without additionally biopsy confirmation.
Lesions of any surface span as long as =< 1 cm in maximal height measured from the skin surface for which local control is desired are eligible; a single patient may have multiple eligible lesions that are individually enrolled for the study.
Disqualifiers
Pregnant patients do not meet inclusion criteria for radiation therapy.
Patients who subsequently become pregnant may continue follow up within the protocol, but a negative urine pregnancy test will need to be obtained before additional lesions may be enrolled.
Patients with active lupus or scleroderma
Lesions with a height > 1 cm measured from the skin surface are not eligible for this protocol.
Trial design
Design model
Single group
Treatments tested in this trial
Quality-of-Life Assessment
Other interventionAncillary studies
Questionnaire Administration
Other interventionAncillary studies
Radiation Therapy
RadiationUndergo ultra low dose radiation therapy
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Treatment (ultra low dose radiation therapy)Experimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Local cutaneous control
Defined as local control of the treated lesion within the radiation treatment field, which will be categorized as either complete response or partial response of the lesion within the radiation treatment field. The control rate will be estimated along with 95% confidence intervals. The association between control rate and patient's clinical characteristics will be examined by Wilcoxon's rank sum test or Fisher's exact test, as appropriate. For each patient, the number of lesions under control will be summarized individually. Since there may be multiple lesions per patient, a generalized linear mixed model will be utilized to assess the clinical factor effect (e.g. previous therapies) on control rate after considering the dependence among the lesions within each patient.
Time frame
At 12 (+/-2) weeks after initial treatmentSecondary outcomes
1
Stable disease, progressive disease, or local regional control (local control within the radiation field margin but not encompassing the original treated lesion)
Will be described with frequency tables.
Time frame
Up to 2 years2
Overall survival
Will be described with frequency tables. Will be conducted using the Kaplan Meier Method.
Time frame
From initiation of treatment until death, assessed up to 2 years3
Progression free survival
Will be described with frequency tables. Will be conducted using the Kaplan Meier Method.
Time frame
From treatment until progression or death, assessed up to 2 years4
Frequency/severity of skin toxicity
Defined by patient reported symptom surveys. Toxicity type (acute or chronic), severity and attribution will be summarized for each patient using frequency tables. Different time points (e.g. pre and post-treatment) will be compared using a paired t-test or Wilcoxon signed rank test as appropriate.
Time frame
Up to 14 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
M.D. Anderson Cancer Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov