TOtal Skin Electron Beam Therapy (Low-dose) for Tumor Clone Eradication in Early-stage Mycosis Fungoides
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Low-dose total-skin electron-beam therapy, Phototherapy.
- Who it may be relevant to
- Registry conditions: Mycosis Fungoides, Cutaneous T Cell Lymphoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
TOtal Skin Electron Beam Therapy (Low-dose) for Tumor Clone Eradication in Early-stage Mycosis Fungoides: a Prospective Randomized Controlled Study
Overview
Primary cutaneous T-cell lymphomas are a group of peripheral T-cell lymphomas that primarily involve the skin. Mycosis fungoides (MF) is the most frequent subtype. Most patients with early-stage MF (i.e., patches and plaques of the skin without extracutaneous involvement) have a good prognosis but a subset of patients progress to incurable advanced-stage disease with an overall survival (OS) less than 5 years and an impaired quality of life. We have recently identified the tumor clone frequency in lesional skin (measured by high-throughput sequencing of the TCRB locus) as the most important prognostic factor of progression-free survival (PFS) and OS in a retrospective analysis on 210 patients with early-stage MF (p\<0.001). Phototherapy is a standard therapeutic option in early-stage MF but fails to eradicate the tumor clone from the skin. Low-dose total-skin electron-beam therapy (LDTSEBT, 12 Gy over a 3-week period) has been shown to be safe and highly effective in MF with an 88% overall response rate and a better safety profile compared to standard-dose total-skin electron-beam therapy, in a pooled analysis from 3 phase II trials on 33 patients and a retrospective analysis of 12 patients treated with LDTSEBT. We hypothesize that the use of LDTSEBT is associated with a significantly higher 1-year PFS compared to conventional treatment with phototherapy. Our secondary hypotheses are that LDTSEBT is associated with a higher tumor T-cell clone eradication compared to phototherapy, and improves OS and quality of life in patients with skin-limited MF. The main objective of this study is therefore to prospectively determine if LDTSEBT is associated with a higher 1-year progression-free survival in patients with early-stage mycosis fungoides, compared to conventional treatment with phototherapy. The primary endpoint is PFS at 12 months after study inclusion.
Interventions
- Other Low-dose total-skin electron-beam therapy
Low-dose total skin electron beam therapy (12 Gy) will be delivered to the patient in 4 Gy/week, 1 Gy/day over 3 weeks by symmetrical electron beams of 6 MeV energy via a linac accelerator. - Other Phototherapy
Phototherapy will be given 3 times a week during 2 months, then twice a week during one month, then once a week during one month, or until disease progression or unacceptable side effect, whatever comes first. Patients with plaques will receive PUVA therapy and patients with patches only will receive narrow-band UVB therapy.
Primary outcome measures
- Progression free survival [Time frame: at 12 months]
Secondary outcome measures (12)
- Proportion of patients with tumor clone eradication in skin [Time frame: at 4 months after inclusion]
- Complete response rate [Time frame: at 4 months after inclusion]
- Overall response rates [Time frame: at 4 months after inclusion]
- Progression-free survival [Time frame: at 5 years post inclusion]
- Overall survival [Time frame: at 5 years post inclusion]
- Quality of life as measured by the EORTC QLQ-C30 [Time frame: at inclusion]
- Quality of life as measured by the EORTC QLQ-C30 [Time frame: at 1 month]
- Quality of life as measured by the EORTC QLQ-C30 [Time frame: at 4 months]
- Quality of life as measured by the EORTC QLQ-C30 [Time frame: at 1 year]
- Quality of life as measured by the EORTC QLQ-C30 [Time frame: at 2 years]
- Quality of life as measured by the EORTC QLQ-C30 [Time frame: at 3 years]
- Quality of life as measured by the EORTC QLQ-C30 [Time frame: at 4 years]
Eligibility criteria
Inclusion criteria
- Age ≥ 18 years
- Histopathologically confirmed diagnosis of International Society for Cutaneous Lymphomas (ISCL) / European Organisation for Research and Treatment of Cancer (EORTC) mycosis fungoides stage IB or IIA
Exclusion criteria
- Poor performance status: WHO performance status score > 2
- Physically unable to maintain the posture
- Patient with no health coverage
- Patient under guardianship or curatorship
- Previous history of dose-limiting radiation therapy in the field
- Previous history of dose-limiting phototherapy
- Previous history of melanoma, skin squamous cell carcinoma or basal cell carcinoma or other absolute contraindication to phototherapy (including a history of lupus, xeroderma pigmentosum, or porphyria)
- Pregnant or breastfeeding woman
- Contraindication to methoxsalen (severe liver, renal or heart failure)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT05205902 · APHP200128