Status:
NOT_YET_RECRUITING
TOtal Skin Electron Beam Therapy (Low-dose) for Tumor Clone Eradication in Early-stage Mycosis Fungoides
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Mycosis Fungoides
Cutaneous T Cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
February 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2031
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT05205902
Start Date
February 1 2022
End Date
February 1 2031
Last Update
January 25 2022
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