ID

31558

Description

Sunitinib Malate, Hormone Ablation and Radiation Therapy in Patients With Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00631527

Link

https://clinicaltrials.gov/show/NCT00631527

Keywords

Versions (1)
  1. 9/4/18 9/4/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 4, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT00631527

English

Eligibility Prostate Cancer NCT00631527

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. adenocarcinoma of the prostate with the following high-risk features are eligible: clinical t2c, clinical or pathological t3 or t4 disease or gleason 8-10 disease or psa > 20ng/ml.
Description

Adenocarcinoma of prostate TNM clinical staging | Adenocarcinoma of prostate Gleason score | Prostate specific antigen measurement

Data type

boolean

Alias
UMLS CUI [1,1]
C0007112
UMLS CUI [1,2]
C3258246
UMLS CUI [2,1]
C0007112
UMLS CUI [2,2]
C3203027
UMLS CUI [3]
C0201544
2. patients must have no evidence of metastatic disease by clinical and radiological staging including chest x-ray, bone scan and ct scan of the abdomen and pelvis.
Description

Neoplasm Metastasis Absent TNM clinical staging | Neoplasm Metastasis Absent Chest X-ray | Neoplasm Metastasis Absent Bone scan | Neoplasm Metastasis Absent CT of abdomen and pelvis

Data type

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C3258246
UMLS CUI [2,1]
C0027627
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0039985
UMLS CUI [3,1]
C0027627
UMLS CUI [3,2]
C0332197
UMLS CUI [3,3]
C0203668
UMLS CUI [4,1]
C0027627
UMLS CUI [4,2]
C0332197
UMLS CUI [4,3]
C1641132
3. eastern cooperative oncology group (ecog) performance status 0-1
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
4. calculated creatinine clearance > 35cc/min, absolute neutrophil count > 1,500/mm^3, platelets >/= 100,000/mm^3, ast/alt < 2.5 x upper normal limit (unl), total bilirubin within normal limits (wnl).
Description

Estimation of creatinine clearance by Cockcroft-Gault formula | Absolute neutrophil count | Platelet Count measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Serum total bilirubin measurement

Data type

boolean

Alias
UMLS CUI [1]
C2711451
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0032181
UMLS CUI [4]
C0201899
UMLS CUI [5]
C0201836
UMLS CUI [6]
C1278039
5. no standard contraindications to radiation therapy including prior radiation therapy, inflammatory bowel disease, irritable bowel syndrome, or and collagen vascular disease.
Description

Medical contraindication Absent Therapeutic radiology procedure | Prior radiation therapy Absent | Inflammatory Bowel Diseases Absent | Irritable Bowel Syndrome Absent | Collagen-vascular disease Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C1522449
UMLS CUI [2,1]
C0279134
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0021390
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0022104
UMLS CUI [4,2]
C0332197
UMLS CUI [5,1]
C0262428
UMLS CUI [5,2]
C0332197
6. patients must be at least 18 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
7. patients may have had up to 8 weeks of hormonal therapy defined as luteinizing-hormone releasing hormone or other medical castration therapy prior to registration.
Description

Hormone Therapy | Luteinizing-hormone releasing hormone | Medical Castration

Data type

boolean

Alias
UMLS CUI [1]
C0279025
UMLS CUI [2]
C0023610
UMLS CUI [3]
C1513054
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. prior vegfr/pdgfr inhibitor or other investigational therapy.
Description

VEGFR Inhibitor | PDGFR Inhibitors | Therapy, Investigational

Data type

boolean

Alias
UMLS CUI [1]
C2985521
UMLS CUI [2]
C2916810
UMLS CUI [3]
C0949266
2. inability to take oral medication
Description

Lacking Able to swallow Oral medication

Data type

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C2712086
UMLS CUI [1,3]
C0175795
3. chronically uncontrolled hypertension, defined conventionally as consistent/repeated systolic pressures above 140 mmhg or diastolic pressures above 90 mmhg despite anti-hypertensive therapy. this may be established with home bp readings. there is no criterion related to a specific bp result required for eligibility, nor are acute bp elevations that are related to iatrogenic causes, acute pain, or other transient reversible causes considered an exclusion criteria. the intent is to exclude patients with chronically uncontrolled hypertension that might be further exacerbated by sunitinib.
Description

Uncontrolled hypertension chronic | Systolic Pressure | Diastolic blood pressure | Antihypertensive therapy | Risk Exacerbation Due to Sunitinib

Data type

boolean

Alias
UMLS CUI [1,1]
C1868885
UMLS CUI [1,2]
C0205191
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0428883
UMLS CUI [4]
C0585941
UMLS CUI [5,1]
C0035647
UMLS CUI [5,2]
C4086268
UMLS CUI [5,3]
C0678226
UMLS CUI [5,4]
C1176020
4. left ventricular ejection fraction </= 40%, symptomatic congestive heart failure or symptomatic ischemic heart disease, deep venous thrombosis or pulmonary embolism in the last 12 months.
Description

Left ventricular ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C0428772
5. known human immunodeficiency virus infection, alcoholism, chronic active hepatitis or liver cirrhosis.
Description

HIV Infection | Alcoholic Intoxication, Chronic | Hepatitis, Chronic | Liver Cirrhosis

Data type

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C0001973
UMLS CUI [3]
C0019189
UMLS CUI [4]
C0023890
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Similar models

Eligibility Prostate Cancer NCT00631527

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma of prostate TNM clinical staging | Adenocarcinoma of prostate Gleason score | Prostate specific antigen measurement
Item
1. adenocarcinoma of the prostate with the following high-risk features are eligible: clinical t2c, clinical or pathological t3 or t4 disease or gleason 8-10 disease or psa > 20ng/ml.
boolean
C0007112 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0007112 (UMLS CUI [2,1])
C3203027 (UMLS CUI [2,2])
C0201544 (UMLS CUI [3])
Neoplasm Metastasis Absent TNM clinical staging | Neoplasm Metastasis Absent Chest X-ray | Neoplasm Metastasis Absent Bone scan | Neoplasm Metastasis Absent CT of abdomen and pelvis
Item
2. patients must have no evidence of metastatic disease by clinical and radiological staging including chest x-ray, bone scan and ct scan of the abdomen and pelvis.
boolean
C0027627 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C3258246 (UMLS CUI [1,3])
C0027627 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0039985 (UMLS CUI [2,3])
C0027627 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0203668 (UMLS CUI [3,3])
C0027627 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C1641132 (UMLS CUI [4,3])
ECOG performance status
Item
3. eastern cooperative oncology group (ecog) performance status 0-1
boolean
C1520224 (UMLS CUI [1])
Estimation of creatinine clearance by Cockcroft-Gault formula | Absolute neutrophil count | Platelet Count measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Serum total bilirubin measurement
Item
4. calculated creatinine clearance > 35cc/min, absolute neutrophil count > 1,500/mm^3, platelets >/= 100,000/mm^3, ast/alt < 2.5 x upper normal limit (unl), total bilirubin within normal limits (wnl).
boolean
C2711451 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0201899 (UMLS CUI [4])
C0201836 (UMLS CUI [5])
C1278039 (UMLS CUI [6])
Medical contraindication Absent Therapeutic radiology procedure | Prior radiation therapy Absent | Inflammatory Bowel Diseases Absent | Irritable Bowel Syndrome Absent | Collagen-vascular disease Absent
Item
5. no standard contraindications to radiation therapy including prior radiation therapy, inflammatory bowel disease, irritable bowel syndrome, or and collagen vascular disease.
boolean
C1301624 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1522449 (UMLS CUI [1,3])
C0279134 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0021390 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0022104 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0262428 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
Age
Item
6. patients must be at least 18 years of age
boolean
C0001779 (UMLS CUI [1])
Hormone Therapy | Luteinizing-hormone releasing hormone | Medical Castration
Item
7. patients may have had up to 8 weeks of hormonal therapy defined as luteinizing-hormone releasing hormone or other medical castration therapy prior to registration.
boolean
C0279025 (UMLS CUI [1])
C0023610 (UMLS CUI [2])
C1513054 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
VEGFR Inhibitor | PDGFR Inhibitors | Therapy, Investigational
Item
1. prior vegfr/pdgfr inhibitor or other investigational therapy.
boolean
C2985521 (UMLS CUI [1])
C2916810 (UMLS CUI [2])
C0949266 (UMLS CUI [3])
Lacking Able to swallow Oral medication
Item
2. inability to take oral medication
boolean
C0332268 (UMLS CUI [1,1])
C2712086 (UMLS CUI [1,2])
C0175795 (UMLS CUI [1,3])
Uncontrolled hypertension chronic | Systolic Pressure | Diastolic blood pressure | Antihypertensive therapy | Risk Exacerbation Due to Sunitinib
Item
3. chronically uncontrolled hypertension, defined conventionally as consistent/repeated systolic pressures above 140 mmhg or diastolic pressures above 90 mmhg despite anti-hypertensive therapy. this may be established with home bp readings. there is no criterion related to a specific bp result required for eligibility, nor are acute bp elevations that are related to iatrogenic causes, acute pain, or other transient reversible causes considered an exclusion criteria. the intent is to exclude patients with chronically uncontrolled hypertension that might be further exacerbated by sunitinib.
boolean
C1868885 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
C0585941 (UMLS CUI [4])
C0035647 (UMLS CUI [5,1])
C4086268 (UMLS CUI [5,2])
C0678226 (UMLS CUI [5,3])
C1176020 (UMLS CUI [5,4])
Left ventricular ejection fraction
Item
4. left ventricular ejection fraction </= 40%, symptomatic congestive heart failure or symptomatic ischemic heart disease, deep venous thrombosis or pulmonary embolism in the last 12 months.
boolean
C0428772 (UMLS CUI [1])
HIV Infection | Alcoholic Intoxication, Chronic | Hepatitis, Chronic | Liver Cirrhosis
Item
5. known human immunodeficiency virus infection, alcoholism, chronic active hepatitis or liver cirrhosis.
boolean
C0019693 (UMLS CUI [1])
C0001973 (UMLS CUI [2])
C0019189 (UMLS CUI [3])
C0023890 (UMLS CUI [4])
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