ID

31389

Beschrijving

Aggressive Local Therapy for Limited Bone-only Metastasis; ODM derived from: https://clinicaltrials.gov/show/NCT00929214

Link

https://clinicaltrials.gov/show/NCT00929214

Trefwoorden

Versies (1)
  1. 18-08-18 18-08-18 -
Houder van rechten

see clinicaltrials.gov

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18 augustus 2018

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00929214

Engels

Eligibility Breast Cancer NCT00929214

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. breast cancer with metastasis to skeletal sites only
Beschrijving

Breast Carcinoma; Neoplasm Metastasis; Skeletal system

Datatype

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0027627
UMLS CUI [1,3]
C0037253
2. 1 to 3 bone metastatic sites (metastatic lesions in the same bone that are within 3 cm of each other are considered as one site)
Beschrijving

site, metastatic cancer; Skeletal bone

Datatype

boolean

Alias
UMLS CUI [1,1]
C0280457
UMLS CUI [1,2]
C0262950
3. kps greater than or equals to 70
Beschrijving

Karnofsky Performance Status

Datatype

boolean

Alias
UMLS CUI [1]
C0206065
4. absolute neutrophil count of > 1500 per microliter and platelet count > 100,000 per microliter; ast and alkaline phosphatase < = 2.5 x normal limits, bilirubin < = 1.5 x normal limits, calculated creatinine clearance > 50 ml/min using cockcroft-gault formula: crcl male = (140-age) x (wt. in kg)/(serum cr x 72); crcl female = 0.85 x (crcl male)
Beschrijving

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

Datatype

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2]
C0032181
UMLS CUI [3]
C0201899
UMLS CUI [4]
C0201850
UMLS CUI [5]
C1278039
UMLS CUI [6]
C2711451
5. patients may or may not have started bis-phosphonates.
Beschrijving

Diphosphonates Started

Datatype

boolean

Alias
UMLS CUI [1,1]
C0012544
UMLS CUI [1,2]
C1272689
6. patients who have received prior chemotherapy for their original breast cancer treatment are still eligible.
Beschrijving

Prior Chemotherapy; Breast Carcinoma

Datatype

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0678222
7. previous use of systemic therapy for bone metastasis is allowable as long as the systemic therapy use fits within the treatment plan as described in proposed treatment/study plan. (if the patient received less than 3 - 9 months of systemic therapy previously, the use of additional systemic therapy may be necessary to fit within the treatment plan)
Beschrijving

systemic therapy; Neoplasm Metastasis; Skeletal bone; Previous | Treatment Plan

Datatype

boolean

Alias
UMLS CUI [1,1]
C1515119
UMLS CUI [1,2]
C0027627
UMLS CUI [1,3]
C0262950
UMLS CUI [1,4]
C0205156
UMLS CUI [2]
C0599880
8. treating physician assesses tumor to be sufficiently distant from sensitive structures to be able to achieve greater than or equal to 66 gy. (i.e., spinal cord tolerance respected in vertebral body metastasis.
Beschrijving

Treating Physician; localization; Carcinoma; Anatomic structures; Sensitive | Gray unit of radiation dose | Spinal Cord; Tolerance; Neoplasm Metastasis; Body of vertebra

Datatype

boolean

Alias
UMLS CUI [1,1]
C1710470
UMLS CUI [1,2]
C0475264
UMLS CUI [1,3]
C0007097
UMLS CUI [1,4]
C0700276
UMLS CUI [1,5]
C0332324
UMLS CUI [2]
C0556636
UMLS CUI [3,1]
C0037925
UMLS CUI [3,2]
C1704410
UMLS CUI [3,3]
C0027627
UMLS CUI [3,4]
C0223084
9. patients with immanent risk of fracture(s) may receive local therapy prior to systemic therapy. otherwise systemic therapy should be given first as outlined in abstract treatment study plan sections 1 and 2.
Beschrijving

Fracture; Risk | systemic therapy; Local Therapy; Before

Datatype

boolean

Alias
UMLS CUI [1,1]
C0016658
UMLS CUI [1,2]
C0035647
UMLS CUI [2,1]
C1515119
UMLS CUI [2,2]
C1517925
UMLS CUI [2,3]
C0332152
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. distant metastasis to organs (local recurrence and regional lymph node recurrence are not considered as distant metastasis) other than bone
Beschrijving

Distant metastasis present; Organ | Neoplasm Recurrence, Local | Lymph Node Involvement; regional; Recurrence | Neoplasm Metastasis; Skeletal bone

Datatype

boolean

Alias
UMLS CUI [1,1]
C1275402
UMLS CUI [1,2]
C0178784
UMLS CUI [2]
C0027643
UMLS CUI [3,1]
C0806692
UMLS CUI [3,2]
C0205147
UMLS CUI [3,3]
C0034897
UMLS CUI [4,1]
C0027627
UMLS CUI [4,2]
C0262950
2. prior radiation to site(s) of distant metastasis of bone
Beschrijving

Therapeutic radiology procedure; Site of distant metastasis; Skeletal bone; Before

Datatype

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0807944
UMLS CUI [1,3]
C0262950
UMLS CUI [1,4]
C0332152
3. history of scleroderma and systemic lupus erythematosus which increases the risk of toxicity from radiation treatment
Beschrijving

Scleroderma | Lupus Erythematosus, Systemic | Toxic effect; Therapeutic radiology procedure; Risk; Increase

Datatype

boolean

Alias
UMLS CUI [1]
C0011644
UMLS CUI [2]
C0024141
UMLS CUI [3,1]
C0600688
UMLS CUI [3,2]
C1522449
UMLS CUI [3,3]
C0035647
UMLS CUI [3,4]
C0442805
4. second primary malignancy (skin cancer other than melanoma allowed) that is disease free for less than 3 years
Beschrijving

Second Primary Cancers | Malignant neoplasm of skin | melanoma | Disease; Free of (attribute)

Datatype

boolean

Alias
UMLS CUI [1]
C0751623
UMLS CUI [2]
C0007114
UMLS CUI [3]
C0025202
UMLS CUI [4,1]
C0012634
UMLS CUI [4,2]
C0332296
5. premenopausal and postmenopausal (amenorrheic for less than 12 months) women with either a positive or no pregnancy test (serum or urine) at baseline within 7 days study enrollment. postmenopausal women who are amenorrheic for more than 12 months do not require pregnancy test.
Beschrijving

Premenopausal - menopausal status | Postmenopausal state| Pregnancy test positive

Datatype

boolean

Alias
UMLS CUI [1]
C0279752
UMLS CUI [2]
C0232970
UMLS CUI [3]
C0240802
6. women with child-bearing potential not using a reliable an appropriate contraceptive method.
Beschrijving

Childbearing Potential | Contraceptive methods; Inappropriate

Datatype

boolean

Alias
UMLS CUI [1]
C3831118
UMLS CUI [2,1]
C0700589
UMLS CUI [2,2]
C1548788
7. patients with child-bearing potential will agree to use contraception while on study and for 30 days from the date of the last therapy on protocol.
Beschrijving

Childbearing Potential | Contraceptive methods

Datatype

boolean

Alias
UMLS CUI [1]
C3831118
UMLS CUI [2]
C0700589
8. if the patient requires surgery of the bone metastasis, clinically serious comorbidities that render patient not medically fit for surgery (e.g. congestive heart failure, symptomatic coronary artery disease, cardiac arrhythmias and chronic lung disease not well controlled with medication; myocardial infarction within 12 months of enrollment)
Beschrijving

Operative Surgical Procedures; Neoplasm Metastasis; Skeletal bone; Requirement | Comorbidity | Congestive heart failure | Coronary Artery Disease; Symptomatic | Cardiac Arrhythmia | Chronic lung disease | Myocardial Infarction

Datatype

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0027627
UMLS CUI [1,3]
C0262950
UMLS CUI [1,4]
C1514873
UMLS CUI [2]
C0009488
UMLS CUI [3]
C0018802
UMLS CUI [4,1]
C1956346
UMLS CUI [4,2]
C0231220
UMLS CUI [5]
C0003811
UMLS CUI [6]
C0746102
UMLS CUI [7]
C0027051
9. central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant to preclude informed consent or interfere with complying with protocol treatments.
Beschrijving

CNS disorder; Informed Consent; Unable | Mental disorders; Informed Consent; Unable; CNS disorder; Protocols documentation; Therapeutic procedure | Mental disorders; Protocols documentation; Therapeutic procedure Unit

Datatype

boolean

Alias
UMLS CUI [1,1]
C0007682
UMLS CUI [1,2]
C0021430
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C0021430
UMLS CUI [2,3]
C1299582
UMLS CUI [3,1]
C0007682
UMLS CUI [3,2]
C0442711
UMLS CUI [3,3]
C0087111
UMLS CUI [4,1]
C0004936
UMLS CUI [4,2]
C0442711
UMLS CUI [4,3]
C0087111
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Similar models

Eligibility Breast Cancer NCT00929214

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Breast Carcinoma; Neoplasm Metastasis; Skeletal system
Item
1. breast cancer with metastasis to skeletal sites only
boolean
C0678222 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
C0037253 (UMLS CUI [1,3])
site, metastatic cancer; Skeletal bone
Item
2. 1 to 3 bone metastatic sites (metastatic lesions in the same bone that are within 3 cm of each other are considered as one site)
boolean
C0280457 (UMLS CUI [1,1])
C0262950 (UMLS CUI [1,2])
Karnofsky Performance Status
Item
3. kps greater than or equals to 70
boolean
C0206065 (UMLS CUI [1])
Absolute neutrophil count | Platelet Count measurement | Aspartate aminotransferase measurement | Alkaline phosphatase measurement | Serum total bilirubin measurement | Estimation of creatinine clearance by Cockcroft-Gault formula
Item
4. absolute neutrophil count of > 1500 per microliter and platelet count > 100,000 per microliter; ast and alkaline phosphatase < = 2.5 x normal limits, bilirubin < = 1.5 x normal limits, calculated creatinine clearance > 50 ml/min using cockcroft-gault formula: crcl male = (140-age) x (wt. in kg)/(serum cr x 72); crcl female = 0.85 x (crcl male)
boolean
C0948762 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201850 (UMLS CUI [4])
C1278039 (UMLS CUI [5])
C2711451 (UMLS CUI [6])
Diphosphonates Started
Item
5. patients may or may not have started bis-phosphonates.
boolean
C0012544 (UMLS CUI [1,1])
C1272689 (UMLS CUI [1,2])
Prior Chemotherapy; Breast Carcinoma
Item
6. patients who have received prior chemotherapy for their original breast cancer treatment are still eligible.
boolean
C1514457 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
systemic therapy; Neoplasm Metastasis; Skeletal bone; Previous | Treatment Plan
Item
7. previous use of systemic therapy for bone metastasis is allowable as long as the systemic therapy use fits within the treatment plan as described in proposed treatment/study plan. (if the patient received less than 3 - 9 months of systemic therapy previously, the use of additional systemic therapy may be necessary to fit within the treatment plan)
boolean
C1515119 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
C0262950 (UMLS CUI [1,3])
C0205156 (UMLS CUI [1,4])
C0599880 (UMLS CUI [2])
Treating Physician; localization; Carcinoma; Anatomic structures; Sensitive | Gray unit of radiation dose | Spinal Cord; Tolerance; Neoplasm Metastasis; Body of vertebra
Item
8. treating physician assesses tumor to be sufficiently distant from sensitive structures to be able to achieve greater than or equal to 66 gy. (i.e., spinal cord tolerance respected in vertebral body metastasis.
boolean
C1710470 (UMLS CUI [1,1])
C0475264 (UMLS CUI [1,2])
C0007097 (UMLS CUI [1,3])
C0700276 (UMLS CUI [1,4])
C0332324 (UMLS CUI [1,5])
C0556636 (UMLS CUI [2])
C0037925 (UMLS CUI [3,1])
C1704410 (UMLS CUI [3,2])
C0027627 (UMLS CUI [3,3])
C0223084 (UMLS CUI [3,4])
Fracture; Risk | systemic therapy; Local Therapy; Before
Item
9. patients with immanent risk of fracture(s) may receive local therapy prior to systemic therapy. otherwise systemic therapy should be given first as outlined in abstract treatment study plan sections 1 and 2.
boolean
C0016658 (UMLS CUI [1,1])
C0035647 (UMLS CUI [1,2])
C1515119 (UMLS CUI [2,1])
C1517925 (UMLS CUI [2,2])
C0332152 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Distant metastasis present; Organ | Neoplasm Recurrence, Local | Lymph Node Involvement; regional; Recurrence | Neoplasm Metastasis; Skeletal bone
Item
1. distant metastasis to organs (local recurrence and regional lymph node recurrence are not considered as distant metastasis) other than bone
boolean
C1275402 (UMLS CUI [1,1])
C0178784 (UMLS CUI [1,2])
C0027643 (UMLS CUI [2])
C0806692 (UMLS CUI [3,1])
C0205147 (UMLS CUI [3,2])
C0034897 (UMLS CUI [3,3])
C0027627 (UMLS CUI [4,1])
C0262950 (UMLS CUI [4,2])
Therapeutic radiology procedure; Site of distant metastasis; Skeletal bone; Before
Item
2. prior radiation to site(s) of distant metastasis of bone
boolean
C1522449 (UMLS CUI [1,1])
C0807944 (UMLS CUI [1,2])
C0262950 (UMLS CUI [1,3])
C0332152 (UMLS CUI [1,4])
Scleroderma | Lupus Erythematosus, Systemic | Toxic effect; Therapeutic radiology procedure; Risk; Increase
Item
3. history of scleroderma and systemic lupus erythematosus which increases the risk of toxicity from radiation treatment
boolean
C0011644 (UMLS CUI [1])
C0024141 (UMLS CUI [2])
C0600688 (UMLS CUI [3,1])
C1522449 (UMLS CUI [3,2])
C0035647 (UMLS CUI [3,3])
C0442805 (UMLS CUI [3,4])
Second Primary Cancers | Malignant neoplasm of skin | melanoma | Disease; Free of (attribute)
Item
4. second primary malignancy (skin cancer other than melanoma allowed) that is disease free for less than 3 years
boolean
C0751623 (UMLS CUI [1])
C0007114 (UMLS CUI [2])
C0025202 (UMLS CUI [3])
C0012634 (UMLS CUI [4,1])
C0332296 (UMLS CUI [4,2])
Premenopausal - menopausal status | Postmenopausal state| Pregnancy test positive
Item
5. premenopausal and postmenopausal (amenorrheic for less than 12 months) women with either a positive or no pregnancy test (serum or urine) at baseline within 7 days study enrollment. postmenopausal women who are amenorrheic for more than 12 months do not require pregnancy test.
boolean
C0279752 (UMLS CUI [1])
C0232970 (UMLS CUI [2])
C0240802 (UMLS CUI [3])
Childbearing Potential | Contraceptive methods; Inappropriate
Item
6. women with child-bearing potential not using a reliable an appropriate contraceptive method.
boolean
C3831118 (UMLS CUI [1])
C0700589 (UMLS CUI [2,1])
C1548788 (UMLS CUI [2,2])
Childbearing Potential | Contraceptive methods
Item
7. patients with child-bearing potential will agree to use contraception while on study and for 30 days from the date of the last therapy on protocol.
boolean
C3831118 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
Operative Surgical Procedures; Neoplasm Metastasis; Skeletal bone; Requirement | Comorbidity | Congestive heart failure | Coronary Artery Disease; Symptomatic | Cardiac Arrhythmia | Chronic lung disease | Myocardial Infarction
Item
8. if the patient requires surgery of the bone metastasis, clinically serious comorbidities that render patient not medically fit for surgery (e.g. congestive heart failure, symptomatic coronary artery disease, cardiac arrhythmias and chronic lung disease not well controlled with medication; myocardial infarction within 12 months of enrollment)
boolean
C0543467 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
C0262950 (UMLS CUI [1,3])
C1514873 (UMLS CUI [1,4])
C0009488 (UMLS CUI [2])
C0018802 (UMLS CUI [3])
C1956346 (UMLS CUI [4,1])
C0231220 (UMLS CUI [4,2])
C0003811 (UMLS CUI [5])
C0746102 (UMLS CUI [6])
C0027051 (UMLS CUI [7])
CNS disorder; Informed Consent; Unable | Mental disorders; Informed Consent; Unable; CNS disorder; Protocols documentation; Therapeutic procedure | Mental disorders; Protocols documentation; Therapeutic procedure Unit
Item
9. central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant to preclude informed consent or interfere with complying with protocol treatments.
boolean
C0007682 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0004936 (UMLS CUI [2,1])
C0021430 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
C0007682 (UMLS CUI [3,1])
C0442711 (UMLS CUI [3,2])
C0087111 (UMLS CUI [3,3])
C0004936 (UMLS CUI [4,1])
C0442711 (UMLS CUI [4,2])
C0087111 (UMLS CUI [4,3])
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