Helical Irradiation of Total Skin (HITS) for Cutaneous Lymphoma
Mots clés
Abstrait
Rendez-vous
Dernière vérification: | 12/31/2013 |
Première soumission: | 01/14/2014 |
Inscription estimée soumise: | 01/15/2014 |
Première publication: | 01/19/2014 |
Dernière mise à jour soumise: | 07/31/2014 |
Dernière mise à jour publiée: | 08/03/2014 |
Date de début réelle de l'étude: | 12/31/2013 |
Date d'achèvement primaire estimée: | 11/30/2017 |
Date estimée d'achèvement de l'étude: | 11/30/2017 |
Condition ou maladie
Intervention / traitement
Radiation: HITS for CTCL
Phase
Groupes d'armes
Bras | Intervention / traitement |
---|---|
Experimental: HITS for CTCL Cutaneous T-cell lymphoma treats by helical irradiation of the total skin (HITS) using helical tomotherapy | Radiation: HITS for CTCL Helical irradiation of the total skin by helical tomotherapy |
Critère d'éligibilité
Âges éligibles aux études | 18 Years À 18 Years |
Sexes éligibles à l'étude | All |
Accepte les bénévoles en santé | Oui |
Critères | Inclusion Criteria: 1. The stage I-IV cutaneous T-cell lymphoma (CTCL) of International Society Cutaneous Lymphomas (ISCL) and U.S. Cutaneous Lymphoma Consortium (USCLC)/European Organization for Research & Treatment of Cancer (EORTC), patients who are candidates for TSEB by recommendation of National Comprehensive Cancer Network Guidelines (Version 4.2011, Mycosis fungoid/Sezary syndrome) 2. Patients who are refractory or not feasible to the topic UV irradiation, Interferon alpha, psoralen plus ultraviolet A photochemotherapy, and Isotretinoin or chemotherapy. 3. Eligibility criteria included the following: Karnofsky status 70% or greater; creatinine clearance greater than 50 mL/min; cardiac left ventricular ejection fraction 50% or greater; aspartate aminotransferase and alanine aminotransferase less than 2.5 times the upper limits of institutional normal; adequate pulmonary function as shown by a forced expiratory volume of greater than 60%; and peripheral neuropathy grade 1 or lower. Patients were preassessed for their ability to lie supine for approximately 1 hour. 4. They had to be previously untreated TSEBT. Prior local radiation was permitted. 5. All patients voluntarily signed an informed consent form approved by the Institutional Review Board. Exclusion Criteria: 1. Patient were prior treated by TSEBT for CTCL, another type of cancer, abnormal cardiac function (systolic ejection fraction < 50 percent or an abnormal stress test), chronic respiratory disease (vital capacity or carbon monoxide diffusion, < 50 percent of normal), abnormal liver function (serum bilirubin, > 2.0 mg per deciliter [>35 micromol per liter]; or serum aminotransferase values more than four times the normal value), and psychiatric disease. 2. Females who are pregnant/lactating or planning to be pregnant. 3. Patients with other systemic diseases that required long-term (≥ 2 weeks) usage of glucocorticosteroid or immunosuppressant agent(s) within 4 weeks prior to the initiation of study treatment. 4. Child or handicap are excluded |
Résultat
Mesures des résultats primaires
1. Number of Participants with Serious and Non-Serious Adverse Events [3 months]
Mesures des résultats secondaires
1. Time to Disease Progression [Up to 24 ms]