ID

20943

Description

This study is a prospective, interventional, open-label, multi-center early access program for the use of Ra-223 Cl2 in HRPC/CRPC (Hormone refractory prostate cancer / Castrate resistant prostate cancer) patients diagnosed with bone metastasis and to collect additional short and long term safety data on the product. NCT01618370

Keywords

Versions (1)
  1. 3/30/17 3/30/17 -
Uploaded on

March 30, 2017

DOI

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License

Creative Commons BY-NC 3.0
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Radium-223 Dichloride (Alpharadin) DRKS00006460 NCT01618370 in Castration-Resistant (Hormone-Refractory) Prostate Cancer Patients With Bone Metastases (Procedures during Active Follow-up)

English

Radium 223 Dichloride (Alpharadin) - Procedures during Active Follow-up

1 forms  
Radiotherapy
Description

Radiotherapy

Has the subject received any radiotherapy associated with the cancer under study during follow-up?
Description

Radiotherapy during follow-up

Data type

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C3274571
Regimen number
Description

Regimen number

Data type

text

Alias
UMLS CUI [1,1]
C0040808
UMLS CUI [1,2]
C0237753
Irradiated location 1
Description

Irradiation site

Data type

text

Alias
UMLS CUI [1]
C2169202
Irradiated location 2
Description

Irradiation site

Data type

text

Alias
UMLS CUI [1]
C2169202
Irradiated location 3
Description

Irradiation site

Data type

text

Alias
UMLS CUI [1]
C2169202
Intent
Description

Intention

Data type

text

Alias
UMLS CUI [1,1]
C1283828
UMLS CUI [1,2]
C1522449
Intent
Description

Intention

Data type

text

Alias
UMLS CUI [1,1]
C1283828
UMLS CUI [1,2]
C1522449
Was this radiotherapy given to relieve skeletal symptoms?
Description

Was this radiotherapy given to relieve skeletal symptoms

Data type

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0683368
UMLS CUI [1,3]
C1301676
Type of radiotherapy
Description

Type of radiotherapy

Data type

text

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0332307
Date of first fraction
Description

dd MMM Y.Y.Y.Y

Data type

date

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0011008
Date of last fraction
Description

dd MMM Y.Y.Y.Y

Data type

date

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0011008
Total cumulative dose
Description

(include units)

Data type

text

Alias
UMLS CUI [1,1]
C2986497
UMLS CUI [1,2]
C1522449
Best response
Description

Best response

Data type

text

Alias
UMLS CUI [1]
C2986560
Concurrent Diagnostic and Therapeutic Procedures for prostate cancer
Description

Concurrent Diagnostic and Therapeutic Procedures for prostate cancer

Has the subject undergone any concurrent diagnostic or therapeutic procedures associated with the cancer under study (including surgery and biopsy)?
Description

concurrent diagnostic or therapeutic procedures

Data type

boolean

Alias
UMLS CUI [1,1]
C0205420
UMLS CUI [1,2]
C1576868
Procedure
Description

Procedure

Data type

text

Alias
UMLS CUI [1]
C0184661
Other procedure: please specify
Description

Other procedure

Data type

text

Alias
UMLS CUI [1]
C0393107
Location
Description

Location

Data type

text

Alias
UMLS CUI [1]
C0450429
Other location: please specify
Description

Other location

Data type

text

Alias
UMLS CUI [1,1]
C0450429
UMLS CUI [1,2]
C0205394
Date of procedure
Description

ddMMMyyyy

Data type

date

Alias
UMLS CUI [1]
C2584899
Purpose of procedure
Description

Purpose of procedure

Data type

text

Alias
UMLS CUI [1]
C0517852
Histopathological or surgery findings
Description

Histopathological or surgery findings

Data type

text

Alias
UMLS CUI [1,1]
C0311392
UMLS CUI [1,2]
C0243140
UMLS CUI [2,1]
C0311392
UMLS CUI [2,2]
C0038895
Systemic Anti-Cancer Therapy
Description

Systemic Anti-Cancer Therapy

Has the subject received any systemic anti-cancer therapy during follow-up?
Description

May include chemotherapy, hormonal therapy, immunotherapy, and non-conventional therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205373
Regimen number
Description

Regimen number

Data type

text

Alias
UMLS CUI [1,1]
C0040808
UMLS CUI [1,2]
C0237753
Is this treatment for a new primary malignancy?
Description

Second primary

Data type

boolean

Alias
UMLS CUI [1,1]
C0751623
UMLS CUI [1,2]
C0920425
Intent
Description

Intention

Data type

text

Alias
UMLS CUI [1,1]
C1283828
UMLS CUI [1,2]
C1522449
Type
Description

Type

Data type

text

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0332307
Drug name
Description

(Use trade name where possible)

Data type

text

Alias
UMLS CUI [1]
C2360065
Start Date
Description

ddMMMyyyy

Data type

date

Alias
UMLS CUI [1]
C0808070
Ongoing at stop of follow-up
Description

Ongoing

Data type

boolean

Alias
UMLS CUI [1]
C0549178
Stop date
Description

ddMMMyyyy

Data type

date

Alias
UMLS CUI [1]
C0806020
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Similar models

Radium 223 Dichloride (Alpharadin) - Procedures during Active Follow-up

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Radiotherapy
Radiotherapy during follow-up
Item
Has the subject received any radiotherapy associated with the cancer under study during follow-up?
boolean
C1522449 (UMLS CUI [1,1])
C3274571 (UMLS CUI [1,2])
Regimen number
Item
Regimen number
text
C0040808 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Irradiation site
Item
Irradiated location 1
text
C2169202 (UMLS CUI [1])
Irradiation site
Item
Irradiated location 2
text
C2169202 (UMLS CUI [1])
Irradiation site
Item
Irradiated location 3
text
C2169202 (UMLS CUI [1])
Intention
Item
Intent
text
C1283828 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])
Intention
Item
Intent
text
C1283828 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])
Was this radiotherapy given to relieve skeletal symptoms
Item
Was this radiotherapy given to relieve skeletal symptoms?
boolean
C1522449 (UMLS CUI [1,1])
C0683368 (UMLS CUI [1,2])
C1301676 (UMLS CUI [1,3])
Type of radiotherapy
Item
Type of radiotherapy
text
C1522449 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Date of first fraction
Item
Date of first fraction
date
C1522449 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Date of last fraction
Item
Date of last fraction
date
C1522449 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Total cumulative dose
Item
Total cumulative dose
text
C2986497 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])
Best response
Item
Best response
text
C2986560 (UMLS CUI [1])
Item Group
Concurrent Diagnostic and Therapeutic Procedures for prostate cancer
concurrent diagnostic or therapeutic procedures
Item
Has the subject undergone any concurrent diagnostic or therapeutic procedures associated with the cancer under study (including surgery and biopsy)?
boolean
C0205420 (UMLS CUI [1,1])
C1576868 (UMLS CUI [1,2])
Procedure
Item
Procedure
text
C0184661 (UMLS CUI [1])
Other procedure
Item
Other procedure: please specify
text
C0393107 (UMLS CUI [1])
Location
Item
Location
text
C0450429 (UMLS CUI [1])
Other location
Item
Other location: please specify
text
C0450429 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Date of procedure
Item
Date of procedure
date
C2584899 (UMLS CUI [1])
Purpose of procedure
Item
Purpose of procedure
text
C0517852 (UMLS CUI [1])
Histopathological or surgery findings
Item
Histopathological or surgery findings
text
C0311392 (UMLS CUI [1,1])
C0243140 (UMLS CUI [1,2])
C0311392 (UMLS CUI [2,1])
C0038895 (UMLS CUI [2,2])
Item Group
Systemic Anti-Cancer Therapy
systemic anti-cancer therapy
Item
Has the subject received any systemic anti-cancer therapy during follow-up?
boolean
C0920425 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
Regimen number
Item
Regimen number
text
C0040808 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Second primary
Item
Is this treatment for a new primary malignancy?
boolean
C0751623 (UMLS CUI [1,1])
C0920425 (UMLS CUI [1,2])
Intention
Item
Intent
text
C1283828 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])
Type
Item
Type
text
C0087111 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Drug name
Item
Drug name
text
C2360065 (UMLS CUI [1])
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
Ongoing
Item
Ongoing at stop of follow-up
boolean
C0549178 (UMLS CUI [1])
Stop date
Item
Stop date
date
C0806020 (UMLS CUI [1])
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