ID

35632

Descripción

Helical Irradiation of Total Skin (HITS) for Cutaneous Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT02039895

Link

https://clinicaltrials.gov/show/NCT02039895

Palabras clave

Versiones (1)
  1. 13/3/19 13/3/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

13 de marzo de 2019

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Cutaneous T-cell Lymphoma NCT02039895

Inglés

Eligibility Cutaneous T-cell Lymphoma NCT02039895

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
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)
Descripción

Cutaneous T-Cell Lymphoma Ann Arbor lymphoma staging system | Patients Appropriate Total Skin Electron Beam Radiation Therapy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0079773
UMLS CUI [1,2]
C0432516
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C1548787
UMLS CUI [2,3]
C2985561
2. patients who are refractory or not feasible to the topic uv irradiation, interferon alpha, psoralen plus ultraviolet a photochemotherapy, and isotretinoin or chemotherapy.
Descripción

Patients Unresponsive to Treatment | UV Radiation Topical Unsuccessful | Interferon-alpha Unsuccessful | PUVA Photochemotherapy Unsuccessful | Isotretinoin Unsuccessful | Chemotherapy Unsuccessful

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0205269
UMLS CUI [2,1]
C4319812
UMLS CUI [2,2]
C0332237
UMLS CUI [2,3]
C1272705
UMLS CUI [3,1]
C0002199
UMLS CUI [3,2]
C1272705
UMLS CUI [4,1]
C0853073
UMLS CUI [4,2]
C1272705
UMLS CUI [5,1]
C0022265
UMLS CUI [5,2]
C1272705
UMLS CUI [6,1]
C0392920
UMLS CUI [6,2]
C1272705
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.
Descripción

Karnofsky Performance Status | Creatinine clearance measurement | Left ventricular ejection fraction | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Pulmonary function | Forced expiratory volume procedure | Peripheral Neuropathy CTCAE Grades | Able to lie down Supine Position Duration

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0206065
UMLS CUI [2]
C0373595
UMLS CUI [3]
C0428772
UMLS CUI [4]
C0201899
UMLS CUI [5]
C0201836
UMLS CUI [6]
C0231921
UMLS CUI [7]
C1306036
UMLS CUI [8,1]
C0031117
UMLS CUI [8,2]
C1516728
UMLS CUI [9,1]
C0560841
UMLS CUI [9,2]
C0038846
UMLS CUI [9,3]
C0449238
4. they had to be previously untreated tsebt. prior local radiation was permitted.
Descripción

Total Skin Electron Beam Radiation Therapy Absent | Therapeutic radiology procedure Local allowed

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2985561
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0205276
UMLS CUI [2,3]
C0683607
5. all patients voluntarily signed an informed consent form approved by the institutional review board.
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
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.
Descripción

Total Skin Electron Beam Radiation Therapy Cutaneous T-Cell Lymphoma | Cancer Other | Cardiac function test abnormal | Cardiac ejection fraction Systolic | Cardiac stress test abnormal | Chronic disease of respiratory system | Reduced vital capacity | Decreased carbon monoxide diffusion capacity | Liver Dysfunction | Serum total bilirubin measurement | Alanine aminotransferase increased | Aspartate aminotransferase increased | Mental disorders

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2985561
UMLS CUI [1,2]
C0079773
UMLS CUI [2]
C1707251
UMLS CUI [3]
C0438177
UMLS CUI [4,1]
C0232174
UMLS CUI [4,2]
C0039155
UMLS CUI [5]
C1096350
UMLS CUI [6]
C0264220
UMLS CUI [7]
C0476408
UMLS CUI [8]
C3806331
UMLS CUI [9]
C0086565
UMLS CUI [10]
C1278039
UMLS CUI [11]
C0151905
UMLS CUI [12]
C0151904
UMLS CUI [13]
C0004936
2. females who are pregnant/lactating or planning to be pregnant.
Descripción

Pregnancy | Breast Feeding | Pregnancy, Planned

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
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.
Descripción

Systemic disease | Requirement Glucocorticoids Long-term | Requirement Immunosuppressive Agents Long-term

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0442893
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C0017710
UMLS CUI [2,3]
C0443252
UMLS CUI [3,1]
C1514873
UMLS CUI [3,2]
C0021081
UMLS CUI [3,3]
C0443252
4. child or handicap are excluded
Descripción

Child | Handicap

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0008059
UMLS CUI [2]
C0231172
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Similar models

Eligibility Cutaneous T-cell Lymphoma NCT02039895

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Cutaneous T-Cell Lymphoma Ann Arbor lymphoma staging system | Patients Appropriate Total Skin Electron Beam Radiation Therapy
Item
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)
boolean
C0079773 (UMLS CUI [1,1])
C0432516 (UMLS CUI [1,2])
C0030705 (UMLS CUI [2,1])
C1548787 (UMLS CUI [2,2])
C2985561 (UMLS CUI [2,3])
Patients Unresponsive to Treatment | UV Radiation Topical Unsuccessful | Interferon-alpha Unsuccessful | PUVA Photochemotherapy Unsuccessful | Isotretinoin Unsuccessful | Chemotherapy Unsuccessful
Item
2. patients who are refractory or not feasible to the topic uv irradiation, interferon alpha, psoralen plus ultraviolet a photochemotherapy, and isotretinoin or chemotherapy.
boolean
C0030705 (UMLS CUI [1,1])
C0205269 (UMLS CUI [1,2])
C4319812 (UMLS CUI [2,1])
C0332237 (UMLS CUI [2,2])
C1272705 (UMLS CUI [2,3])
C0002199 (UMLS CUI [3,1])
C1272705 (UMLS CUI [3,2])
C0853073 (UMLS CUI [4,1])
C1272705 (UMLS CUI [4,2])
C0022265 (UMLS CUI [5,1])
C1272705 (UMLS CUI [5,2])
C0392920 (UMLS CUI [6,1])
C1272705 (UMLS CUI [6,2])
Karnofsky Performance Status | Creatinine clearance measurement | Left ventricular ejection fraction | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Pulmonary function | Forced expiratory volume procedure | Peripheral Neuropathy CTCAE Grades | Able to lie down Supine Position Duration
Item
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.
boolean
C0206065 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
C0428772 (UMLS CUI [3])
C0201899 (UMLS CUI [4])
C0201836 (UMLS CUI [5])
C0231921 (UMLS CUI [6])
C1306036 (UMLS CUI [7])
C0031117 (UMLS CUI [8,1])
C1516728 (UMLS CUI [8,2])
C0560841 (UMLS CUI [9,1])
C0038846 (UMLS CUI [9,2])
C0449238 (UMLS CUI [9,3])
Total Skin Electron Beam Radiation Therapy Absent | Therapeutic radiology procedure Local allowed
Item
4. they had to be previously untreated tsebt. prior local radiation was permitted.
boolean
C2985561 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C0205276 (UMLS CUI [2,2])
C0683607 (UMLS CUI [2,3])
Informed Consent
Item
5. all patients voluntarily signed an informed consent form approved by the institutional review board.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Total Skin Electron Beam Radiation Therapy Cutaneous T-Cell Lymphoma | Cancer Other | Cardiac function test abnormal | Cardiac ejection fraction Systolic | Cardiac stress test abnormal | Chronic disease of respiratory system | Reduced vital capacity | Decreased carbon monoxide diffusion capacity | Liver Dysfunction | Serum total bilirubin measurement | Alanine aminotransferase increased | Aspartate aminotransferase increased | Mental disorders
Item
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.
boolean
C2985561 (UMLS CUI [1,1])
C0079773 (UMLS CUI [1,2])
C1707251 (UMLS CUI [2])
C0438177 (UMLS CUI [3])
C0232174 (UMLS CUI [4,1])
C0039155 (UMLS CUI [4,2])
C1096350 (UMLS CUI [5])
C0264220 (UMLS CUI [6])
C0476408 (UMLS CUI [7])
C3806331 (UMLS CUI [8])
C0086565 (UMLS CUI [9])
C1278039 (UMLS CUI [10])
C0151905 (UMLS CUI [11])
C0151904 (UMLS CUI [12])
C0004936 (UMLS CUI [13])
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
2. females who are pregnant/lactating or planning to be pregnant.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Systemic disease | Requirement Glucocorticoids Long-term | Requirement Immunosuppressive Agents Long-term
Item
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.
boolean
C0442893 (UMLS CUI [1])
C1514873 (UMLS CUI [2,1])
C0017710 (UMLS CUI [2,2])
C0443252 (UMLS CUI [2,3])
C1514873 (UMLS CUI [3,1])
C0021081 (UMLS CUI [3,2])
C0443252 (UMLS CUI [3,3])
Child | Handicap
Item
4. child or handicap are excluded
boolean
C0008059 (UMLS CUI [1])
C0231172 (UMLS CUI [2])
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