[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100455081":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":21,"centralContacts":24,"locations":21,"responsibleParty":34,"collaborators":21,"id":36,"slug":37,"hasResults":38,"nctId":39,"briefTitle":40,"officialTitle":41,"acronym":42,"eligibilityCriteria":43,"healthyVolunteers":38,"sex":44,"minAge":45,"maxAge":21,"enrollmentInfo":46,"targetDuration":21,"studyType":49,"phases":50,"briefSummary":52,"conditions":53,"keywords":21,"overallStatus":56,"whyStopped":21,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":21},{"fullName":5,"class":6},"Assistance Publique - Hôpitaux de Paris","OTHER",[8,13],{"label":9,"type":6,"description":10,"interventionNames":11},"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\u002Fweek, 1 Gy\u002Fday over 3 weeks by symmetrical electron beams of 6 MeV energy via a linac accelerator.",[12],"Other: Low-dose total-skin electron-beam therapy",{"label":14,"type":6,"description":15,"interventionNames":16},"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.\n\nPatients with plaques will receive PUVA therapy and patients with patches only will receive narrow-band UVB therapy.",[17],"Other: Phototherapy",[19,22],{"type":6,"name":9,"description":10,"armGroupLabels":20,"otherNames":21},[9],null,{"type":6,"name":14,"description":15,"armGroupLabels":23,"otherNames":21},[14],[25,30],{"name":26,"role":27,"phone":28,"phoneExt":21,"email":29},"Adèle DEMASSON","CONTACT","+33171 20 75 01","adele.demasson@aphp.fr",{"name":31,"role":27,"phone":32,"phoneExt":21,"email":33},"Matthieu Resche-Rigon","+33142499742","matthieu.resche-rigon@u-paris.fr",{"type":35,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR","100455081","phase-3-total-skin-electron-beam-therapy-low-dose-for-tumor-clone-eradication-in-early-stage-mycosis-fungoides-100455081",false,"NCT05205902","TOtal Skin Electron Beam Therapy (Low-dose) for Tumor Clone Eradication in Early-stage Mycosis Fungoides","TOtal Skin Electron Beam Therapy (Low-dose) for Tumor Clone Eradication in Early-stage Mycosis Fungoides: a Prospective Randomized Controlled Study","TOTEM-01","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Histopathologically confirmed diagnosis of International Society for Cutaneous Lymphomas (ISCL) \u002F European Organisation for Research and Treatment of Cancer (EORTC) mycosis fungoides stage IB or IIA\n\nExclusion Criteria:\n\n* Poor performance status: WHO performance status score \\> 2\n* Physically unable to maintain the posture\n* Patient with no health coverage\n* Patient under guardianship or curatorship\n* Previous history of dose-limiting radiation therapy in the field\n* Previous history of dose-limiting phototherapy\n* 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)\n* Pregnant or breastfeeding woman\n* Contraindication to methoxsalen (severe liver, renal or heart failure)","ALL","18 Years",{"count":47,"type":48},78,"ESTIMATED","INTERVENTIONAL",[51],"PHASE3","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.\n\nWe 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\\\u003C0.001).\n\nPhototherapy is a standard therapeutic option in early-stage MF but fails to eradicate the tumor clone from the skin.\n\nLow-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.\n\nWe 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.\n\nThe 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.\n\nThe primary endpoint is PFS at 12 months after study inclusion.",[54,55],"Mycosis Fungoides","Cutaneous T Cell Lymphoma","NOT_YET_RECRUITING","2022-01-24",{"date":59,"type":60},"2022-01-25","ACTUAL",{"date":62,"type":48},"2022-02",{"date":64,"type":48},"2031-02",{"name":5,"class":6}]