ID

7770

Beschreibung

ACOSOG-Z4099 Evaluation/Treatment Form Surgery With or Without Internal Radiation Therapy Compared With Stereotactic Body Radiation Therapy in Treating Patients With High-Risk Stage I Non-Small Cell Lung Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=990BA4F9-5291-85C0-E040-BB89AD433BEA

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=990BA4F9-5291-85C0-E040-BB89AD433BEA

Stichworte

Lungentumoren

Klinische Studie [Dokumenttyp]

Treatment Form

18.12.14 18.12.14 - Martin Dugas
09.01.15 09.01.15 - Martin Dugas

Hochgeladen am

9. Januar 2015

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY-NC 3.0 Legacy

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Lung Cancer NCT01336894 Treatment - ACOSOG-Z4099 Evaluation/Treatment Form - 3181065v1.0

Modell
Details

ALL ITEMS MUST BE COMPLETED

1 Formulare

StudyEvent: ACOSOG-Z4099 Evaluation/Treatment Form
1. ALL ITEMS MUST BE COMPLETED

Name

Typ

Description | Question | Decode (Coded Value)

Datentyp

Alias

Header Module

Item Group

Header Module

Protocol ID ACOSOG

Item

Protocol Number

text

C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1515944 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C19712 (NCI Thesaurus Property-2)

Patient Study ID

Item

Patient ID

text

C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25462 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)

Patient Initials

Item

Patient Initials (L F M)

text

C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)

Institution Number

Item

Institution Number

text

C25337 (NCI Thesaurus ValueDomain)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass)
C0805701 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)

Institution Name

Item

Institution

text

C25191 (NCI Thesaurus ValueDomain)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass)
C21541 (NCI Thesaurus ValueDomain-2)
C25364 (NCI Thesaurus Property)

Data amended

Item

Are data amended (check one if data amended, please circle in red when using paper forms)

boolean

C38148 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)

Visit

Item Group

Visit

AmericanCollegeofSurgeonsOncologyGroupVisitPeriodAmericanCollegeofSurgeonsOncologyGroupVisitPeriodType

Item

Visit

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C19712 (NCI Thesaurus ObjectClass)
C1515944 (UMLS 2011AA ObjectClass)
C25716 (NCI Thesaurus ObjectClass-2)
C0545082 (UMLS 2011AA ObjectClass-2)

CL.2

Code List

Visit

CL Item

At Time Of Surgery/stereotactic Body Radiation Therapy (At time of surgery/SBRT)

TherapeuticProcedureReceivedType

Item

Which treatment did the patient receive (check one)

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
C49236 (NCI Thesaurus ObjectClass)
C0087111 (UMLS 2011AA ObjectClass)

CL.3

Code List

Which treatment did the patient receive (check one)

CL Item

Surgery With Brachytherapy (Surgery with brachytherapy)

CL Item

Surgery Without Brachytherapy (Surgery without brachytherapy)

CL Item

Stereotactic Body Radiation Therapy Only (SBRT only)

CL Item

No Treatment Received (No treatment received)

ECOG Performance Status

Item

ECOG Performance Status (used for this visit: check one)

text

C25664 (NCI Thesaurus ValueDomain)
C1520224 (UMLS CUI-1)
C25367 (NCI Thesaurus Property)
C25491 (NCI Thesaurus ValueDomain-2)
C20641 (NCI Thesaurus ObjectClass)

CL.4

Code List

ECOG Performance Status (used for this visit: check one)

CL Item

Fully Active, Able To Carry On All Pre-disease Performance Without Restriction. (0)

CL Item

Restricted In Physically Strenuous Activity But Ambulatory And Able To Carry Out Work Of A Light Or Sedentary Nature, E.g., Light Housework, Office Work. (1)

CL Item

Ambulatory And Capable Of All Selfcare But Unable To Carry Out Any Work Activities. Up And About More Than 50% Of Waking Hours. (2)

CL Item

Capable Of Only Limited Selfcare, Confined To Bed Or Chair More Than 50% Of Waking Hours. (3)

CL Item

Completely Disabled. Cannot Carry On Any Selfcare. Totally Confined To Bed Or Chair. (4)

Surgical Report

Item Group

Header

Surgery Date

Item

Surgery Date (dd MMM yyyy)

date

C25164 (NCI Thesaurus ValueDomain)
C1628561 (UMLS CUI-1)
C25367 (NCI Thesaurus ValueDomain-2)
C15329 (NCI Thesaurus ObjectClass)
C25275 (NCI Thesaurus Property)

RobotDeviceComponentSurgicalProcedurePerformedInd-3

Item

Was surgery Robot assisted (check one)

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C50152 (NCI Thesaurus ObjectClass-2)
C1705185 (UMLS 2011AA ObjectClass-2)

CL.5

Code List

Was surgery Robot assisted (check one)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

TumorLungAreaType

Item

Area (Check all that apply)

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12468 (NCI Thesaurus Property)
C0024109 (UMLS 2011AA Property)
C25244 (NCI Thesaurus Property-2)
C0205146 (UMLS 2011AA Property-2)

CL.6

Code List

Area (Check all that apply)

CL Item

Upper Lobe (right) (Upper Lobe (right))

CL Item

Middle Lobe (right) (Middle Lobe (right))

CL Item

Lower Lobe (right) (Lower Lobe (right))

CL Item

Upper Lobe (left) (Upper Lobe (left))

CL Item

Lower Lobe (left) (Lower Lobe (left))

CL Item

Lingula (Lingula)

Surgical Approach

Item

Surgical Approach (check one)

text

C25284 (NCI Thesaurus ValueDomain)
C0449446 (UMLS CUI-1)
C12468 (NCI Thesaurus ObjectClass)
C15329 (NCI Thesaurus ObjectClass-2)
C25382 (NCI Thesaurus Property)

CL.7

Code List

Surgical Approach (check one)

CL Item

Thoracotomy (thoracotomy)

CL Item

Thoracoscopy / Video-assisted (vats) (Thoracoscopy / Video-assisted (VATS))

Primary Surgery Type

Item

Most Extensive Primary Surgery (check one)

text

C25251 (NCI Thesaurus ObjectClass)
C0944781 (UMLS CUI-1)
C12468 (NCI Thesaurus ObjectClass-2)
C15329 (NCI Thesaurus ObjectClass-3)
C38000 (NCI Thesaurus Property)
C25284 (NCI Thesaurus ValueDomain)

CL.8

Code List

Most Extensive Primary Surgery (check one)

CL Item

Wedge Resection (Wedge Resection)

CL Item

Segmentectomy (Segmentectomy)

CL Item

Exploration, No Resection (Exploration, No Resection)

LungSegmentectomySurgicalProcedurePerformedCount

Item

Total Number of Segments

float

C12468 (NCI Thesaurus ObjectClass)
C0024109 (UMLS 2011AA ObjectClass)
C15329 (NCI Thesaurus ObjectClass-2)
C0543467 (UMLS 2011AA ObjectClass-2)
C91061 (NCI Thesaurus ObjectClass-3)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)

LymphNodeExaminedCount

Item

Number of lymph node stations

float

C25500 (NCI Thesaurus Property)
C0332128 (UMLS 2011AA Property)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)

SurgicalMarginDistanceMeasurement

Item

Size of Margin (cm)

float

C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C25698 (NCI Thesaurus ObjectClass)
C41227 (NCI Thesaurus ObjectClass-2)
C0229985 (UMLS 2011AA ObjectClass)
C25167 (NCI Thesaurus Property)
C0012751 (UMLS 2011AA Property)

AmericanSocietyofAnesthesiologistsPhysicalStatusClassificationScale

Item

ASA Class (check one)

text

C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
CL218277 (NCI Metathesaurus ObjectClass)
C25161 (NCI Thesaurus Property)
C0008902 (UMLS 2011AA Property)

CL.9

Code List

ASA Class (check one)

CL Item

Healthy Patient, No Medical Problems (I)

CL Item

Mild Systemic Disease (II)

CL Item

Severe Systemic Disease, But Not Incapaitating (III)

CL Item

Severe Systemic Disease That Is A Constant Threat To Life (IV)

CL Item

Moribund, Not Expected To Live 24 Hours Irrespective Of Operation (V)

PersonOperatingRoomEnteredTime

Item

Time patient entered OR (use 24 hr clock: 00:00-23:59 h h m m)

time

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25207 (NCI Thesaurus ValueDomain)
C0040223 (UMLS 2011AA ValueDomain)
C37949 (NCI Thesaurus Property)
C1521975 (UMLS 2011AA Property)
C53516 (NCI Thesaurus Property-2)
C0029064 (UMLS 2011AA Property-2)

SkinSurgicalIncisionBeginTime

Item

Skin Incision Start Time (use 24 hr clock: 00:00-23:59 h h m m)

time

C12470 (NCI Thesaurus ObjectClass)
C1123023 (UMLS 2011AA ObjectClass)
C25431 (NCI Thesaurus ValueDomain)
C0439659 (UMLS 2011AA ValueDomain)
C25207 (NCI Thesaurus ValueDomain-2)
C0040223 (UMLS 2011AA ValueDomain-2)
C15384 (NCI Thesaurus Property)
C0184898 (UMLS 2011AA Property)

SkinSurgicalIncisionEndTime

Item

Skin Incision Stop Time (use 24 hr clock: 00:00-23:59 h h m m)

time

C12470 (NCI Thesaurus ObjectClass)
C1123023 (UMLS 2011AA ObjectClass)
C25207 (NCI Thesaurus ValueDomain)
C0040223 (UMLS 2011AA ValueDomain)
C15384 (NCI Thesaurus Property)
C0184898 (UMLS 2011AA Property)

PersonOperatingRoomDepartureTime

Item

Time patient exited OR (use 24 hr clock: 00:00-23:59 h h m m)

time

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25207 (NCI Thesaurus ValueDomain)
C0040223 (UMLS 2011AA ValueDomain)
C53464 (NCI Thesaurus Property)
C1706081 (UMLS 2011AA Property)
C53516 (NCI Thesaurus Property-2)
C0029064 (UMLS 2011AA Property-2)

Final Pathological Stage

Item Group

Final Pathological Stage

LungTumorPathologicTStage

Item

Pathologic T Stage (check one)

text

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12468 (NCI Thesaurus ObjectClass-2)
C0024109 (UMLS 2011AA ObjectClass-2)
C25610 (NCI Thesaurus Property)
C1521733 (UMLS 2011AA Property)
C25728 (NCI Thesaurus Property-2)
C0475455 (UMLS 2011AA Property-2)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)
C39315 (NCI Thesaurus ValueDomain-2)
C1515946 (UMLS 2011AA ValueDomain-2)

CL.10

Code List

Pathologic T Stage (check one)

CL Item

Tumor <=3 Cm In Greatest Dimension, Surrounded By Lung Or Visceral Pleura, Without Bronchoscopic Evidence Of Invasion More Proximal Than The Lobar Bronchus (i.e., Not In The Main Bronchus) (T1)

CL Item

Tumor <=2 Cm In Greatest Dimension (T1a)

CL Item

Tumor > 2 Cm But <=3 Cm In Greatest Dimension (T1b)

CL Item

Tumor > 3 Cm But <=7 Cm Involves Main Bronchus, >=2 Cm Distal To The Carina Invades Visceral Pleura (pl1 Or Pl2) Associated With Atelectasis Or Obstructive Pneumonitis That Extends To The Hilar Region But Does Not Involve The Entire Lung (T2)

CL Item

Tumor > 3 Cm But <=5 Cm In Greatest Dimension (T2a)

CL Item

Tumor > 5 Cm But <=7 Cm In Greatest Dimension (T2b)

CL Item

Tumor > 7 Cm Or One That Directly Invades Any Of The Following: Parietal Pleural (pl3) Chest Wall (including Superior Sulcus Tumors), Diaphragm, Phrenic Nerve, Mediastinal Pleura, Parietal Pericardium; Or Tumor In The Main Bronchus (T3)

CL Item

Tumor Of Any Size That Invades Any Of The Following: Mediastinum, Heart, Great Vessels, Trachea, Recurrent Laryngeal Nerve, Esophagus, Vertebral Body, Carina, Separate Tumor Nodule(s) In A Different Ipsilateral Lobe (T4)

LungTumorPathologicNStage

Item

Pathologic N Stage (check one)

text

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12468 (NCI Thesaurus ObjectClass-2)
C0024109 (UMLS 2011AA ObjectClass-2)
C25610 (NCI Thesaurus Property)
C1521733 (UMLS 2011AA Property)
C25580 (NCI Thesaurus Property-2)
C0456532 (UMLS 2011AA Property-2)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)
C39315 (NCI Thesaurus ValueDomain-2)
C1515946 (UMLS 2011AA ValueDomain-2)

CL.11

Code List

Pathologic N Stage (check one)

CL Item

Regional Lymph Nodes Cannot Be Assessed (NX)

CL Item

No Regional Lymph Node Metastasis (N0)

CL Item

Metastasis In Ipsilateral Peribronchial And/or Ipsilateral Hilar Lymph Nodes And Intrapulmonary Nodes, Including Involvement By Direct Extension (N1)

CL Item

Metastasis In Ipsilateral Mediastinal And/or Subcarinal Lymph Node(s) (N2)

CL Item

Metastasis In Contralateral Mediastinal, Contralateral Hilar, Ipsilateral Or Contralateral Scalene, Or Supraclavicular Lymph Node(s) (N3)

DistantMetastasisPresentInd-2

Item

Distant metastases present? (check one)

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C25321 (NCI Thesaurus ObjectClass)
C0443203 (UMLS 2011AA ObjectClass)
C19151 (NCI Thesaurus ObjectClass-2)
C0027627 (UMLS 2011AA ObjectClass-2)

LungTumorPathologicMStage

Item

Pathologic M Stage (If yes check one)

text

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12468 (NCI Thesaurus ObjectClass-2)
C0024109 (UMLS 2011AA ObjectClass-2)
C25610 (NCI Thesaurus Property)
C1521733 (UMLS 2011AA Property)
C25727 (NCI Thesaurus Property-2)
C0456533 (UMLS 2011AA Property-2)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)
C39315 (NCI Thesaurus ValueDomain-2)
C1515946 (UMLS 2011AA ValueDomain-2)

CL.13

Code List

Pathologic M Stage (If yes check one)

CL Item

Distant Metastasis (M1)

C18206 (NCI Thesaurus)
C1269798 (UMLS 2011AA)
C18206 (NCI Thesaurus-3)
C1269798 (UMLS 2011AA-4)

CL Item

Separate Tumor Nodule(s) In A Contralateral Lobe; Tumor With Pleural Nodules Or Malignant Pleural (or Pericardial) Effusion (M1a)

CL Item

Distant Metastasis (M1b)

C18206 (NCI Thesaurus)
C1269798 (UMLS 2011AA)
C18206 (NCI Thesaurus-3)
C1269798 (UMLS 2011AA-4)

LungSurgicalMarginCytologyStatus

Item

Staple line Cytology (check one)

text

C16491 (NCI Thesaurus Property)
C0010819 (UMLS 2011AA Property)
C12468 (NCI Thesaurus ObjectClass)
C0024109 (UMLS 2011AA ObjectClass)
C41227 (NCI Thesaurus ObjectClass-2)
C0229985 (UMLS 2011AA ObjectClass-2)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)

CL.14

Code List

Staple line Cytology (check one)

CL Item

Negative (Negative)

C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)

CL Item

Positive (Positive)

C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)

LungSurgicalMarginHistologyStatus

Item

Staple line Histology (check one)

text

C16681 (NCI Thesaurus Property)
C0019638 (UMLS 2011AA Property)
C12468 (NCI Thesaurus ObjectClass)
C0024109 (UMLS 2011AA ObjectClass)
C41227 (NCI Thesaurus ObjectClass-2)
C0229985 (UMLS 2011AA ObjectClass-2)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)

CL.15

Code List

Staple line Histology (check one)

CL Item

Negative (Negative)

C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)

CL Item

Positive (Positive)

C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)

PrimaryTumorPathologicSizeType

Item

Pathologic Primary Tumor Size (check one)

text

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25251 (NCI Thesaurus ObjectClass-2)
C0205225 (UMLS 2011AA ObjectClass-2)
C25610 (NCI Thesaurus Property)
C1521733 (UMLS 2011AA Property)
C25681 (NCI Thesaurus Property-2)
C0456389 (UMLS 2011AA Property-2)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)

CL.16

Code List

Pathologic Primary Tumor Size (check one)

CL Item

0 - 1.0 Cm (0 - 1.0 cm)

CL Item

1.1 - 2.0 Cm (1.1 - 2.0 cm)

CL Item

2.1 - 3.0 Cm (2.1 - 3.0 cm)

CL Item

3.1 - 4.0 Cm (3.1 - 4.0 cm)

CL Item

> 4.0 Cm (> 4.0 cm)

LymphNodeRemovedCount

Item

Total number of lymph nodes removed

float

C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C25650 (NCI Thesaurus Property)
C0849355 (UMLS 2011AA Property)

Discharge

Item Group

Discharge

InpatientHospitalDischargeDate

Item

Discharge Date (dd MMM yyyy)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16696 (NCI Thesaurus ObjectClass)
C0019994 (UMLS 2011AA ObjectClass)
C25182 (NCI Thesaurus ObjectClass-2)
C0021562 (UMLS 2011AA ObjectClass-2)
C25166 (NCI Thesaurus Property)
C0030685 (UMLS 2011AA Property)

ChestTubeRemovedDate

Item

Date chest tube removed (CT dd MMM yyyy)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C0008034 (NCI Metathesaurus ObjectClass)
C25650 (NCI Thesaurus Property)
C0849355 (UMLS 2011AA Property)

SurgeonLastName

Item

Surgeon Name, Last (PRINT)

text

C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C18071 (NCI Thesaurus ObjectClass)
C0582175 (UMLS 2011AA ObjectClass)
C25551 (NCI Thesaurus ValueDomain-2)
C1517741 (UMLS 2011AA ValueDomain-2)
C40975 (NCI Thesaurus Property)
C1301584 (UMLS 2011AA Property)

SurgeonFirstName

Item

Surgeon Name, First (PRINT)

text

C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25509 (NCI Thesaurus ValueDomain-2)
C1279901 (UMLS 2011AA ValueDomain-2)
C18071 (NCI Thesaurus ObjectClass)
C0582175 (UMLS 2011AA ObjectClass)
C40974 (NCI Thesaurus Property)
C1443235 (UMLS 2011AA Property)

Brachytherapy

Item Group

Header

BrachytherapyDeliveryTechniqueType

Item

Brachytherapy technique (check one)

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)
C15195 (NCI Thesaurus ObjectClass)
C0006098 (UMLS 2011AA ObjectClass)
C61560 (NCI Thesaurus Property-2)

CL.17

Code List

Brachytherapy technique (check one)

CL Item

Mesh (Mesh)

CL Item

Double Strand (Double strand)

BrachytherapyImplantLengthMeasurement

Item

Length (If Mesh cm)

float

C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C15195 (NCI Thesaurus ObjectClass)
C0006098 (UMLS 2011AA ObjectClass)
C41075 (NCI Thesaurus Property)
C0021102 (UMLS 2011AA Property)
C25334 (NCI Thesaurus Property-2)
C1444754 (UMLS 2011AA Property-2)

BrachytherapyImplantWidthMeasurement

Item

Width (If Mesh cm)

float

C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C15195 (NCI Thesaurus ObjectClass)
C0006098 (UMLS 2011AA ObjectClass)
C41075 (NCI Thesaurus Property)
C0021102 (UMLS 2011AA Property)
C25345 (NCI Thesaurus Property-2)
C0487742 (UMLS 2011AA Property-2)

BrachytherapyImplantType

Item

Mesh type used (check one)

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C15195 (NCI Thesaurus ObjectClass)
C0006098 (UMLS 2011AA ObjectClass)
C17948 (NCI Thesaurus Property)
C0013183 (UMLS 2011AA Property)

CL.18

Code List

Mesh type used (check one)

CL Item

Mesh Seeds Manually Threaded (Mesh seeds manually threaded)

CL Item

Mesh Pre-fabricated By Manufacturer (Mesh pre-fabricated by manufacturer)

BrachytherapySeedImplantationSutureMaterialSequenceNumber

Item

Strand

float

C15195 (NCI Thesaurus ObjectClass)
C0006098 (UMLS 2011AA ObjectClass)
C16219 (NCI Thesaurus ObjectClass-2)
C1519225 (UMLS 2011AA ObjectClass-2)
C42858 (NCI Thesaurus Property)
C0038969 (UMLS 2011AA Property)
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25673 (NCI Thesaurus ValueDomain-2)
C1519249 (UMLS 2011AA ValueDomain-2)

BrachytherapySeedImplantationMeasurement

Item

Length (cm)

float

C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C15195 (NCI Thesaurus ObjectClass)
C0006098 (UMLS 2011AA ObjectClass)
C16219 (NCI Thesaurus Property)
C1519225 (UMLS 2011AA Property)

BrachytherapySeedImplantationSutureMaterialNumber

Item

Seeds per strand

float

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C15195 (NCI Thesaurus ObjectClass)
C0006098 (UMLS 2011AA ObjectClass)
C16219 (NCI Thesaurus ObjectClass-2)
C1519225 (UMLS 2011AA ObjectClass-2)
C42858 (NCI Thesaurus Property)
C0038969 (UMLS 2011AA Property)

BrachytherapySeedImplantationSuturedMaterialDose

Item

Activity/Seed (mCi)

float

C15195 (NCI Thesaurus ObjectClass)
C0006098 (UMLS 2011AA ObjectClass)
C25488 (NCI Thesaurus ValueDomain)
C0178602 (UMLS 2011AA ValueDomain)
C16219 (NCI Thesaurus ObjectClass-2)
C1519225 (UMLS 2011AA ObjectClass-2)
C42858 (NCI Thesaurus Property)
C0038969 (UMLS 2011AA Property)

BrachytherapySeedImplantationSuturedMaterialTotalDose

Item

Total activity (Strand mCi)

float

QualityAssuranceCenterSubmissionInd-2

Item

Have all Stereotactic Body Radiation Therapy Quality Assurance documentation and imaging materials been submitted to the Image-guided Therapy Center (SBRT see Section 5.4.3 ITC check one)

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25445 (NCI Thesaurus Property)
C0205099 (UMLS 2011AA Property)
C25694 (NCI Thesaurus Property-2)
C1515022 (UMLS 2011AA Property-2)
C0178932 (NCI Metathesaurus ObjectClass)

BrachytherapySeedImplantationSutureMaterialTotalAdministrationNumber

Item

Total # Seeds

float

C15195 (NCI Thesaurus ObjectClass)
C0006098 (UMLS 2011AA ObjectClass)
C16219 (NCI Thesaurus ObjectClass-2)
C1519225 (UMLS 2011AA ObjectClass-2)
C42858 (NCI Thesaurus Property)
C0038969 (UMLS 2011AA Property)
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25304 (NCI Thesaurus ValueDomain-2)
C0439810 (UMLS 2011AA ValueDomain-2)
C25409 (NCI Thesaurus ValueDomain-3)
C1533734 (UMLS 2011AA ValueDomain-3)

BrachytherapySeedImplantationSutureMaterialTotalAdministrationDose

Item

Total Activity (mCi)

float

C15195 (NCI Thesaurus ObjectClass)
C0006098 (UMLS 2011AA ObjectClass)
C16219 (NCI Thesaurus ObjectClass-2)
C1519225 (UMLS 2011AA ObjectClass-2)
C42858 (NCI Thesaurus Property)
C0038969 (UMLS 2011AA Property)
C25304 (NCI Thesaurus ValueDomain)
C0439810 (UMLS 2011AA ValueDomain)
C25488 (NCI Thesaurus ValueDomain-2)
C0178602 (UMLS 2011AA ValueDomain-2)
C25409 (NCI Thesaurus ValueDomain-3)
C1533734 (UMLS 2011AA ValueDomain-3)

BrachytherapySeedImplantationSutureMaterialDose

Item

Prescription (Gy)

float

CTPostBrachytherapyDate

Item

Date of post-implant CT (dd MMM yyyy)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C17204 (NCI Thesaurus ObjectClass)
C0040405 (UMLS 2011AA ObjectClass)
C38008 (NCI Thesaurus Property)
C0687676 (UMLS 2011AA Property)
CL054378 (NCI Metathesaurus Property)

SBRT Fraction 1

Item Group

Sbrt Fraction (1)

FractionationRadiationTherapyAdministeredInd-2

Item

Was fraction delivered (check one)

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C15654 (NCI Thesaurus ObjectClass-2)
C0016640 (UMLS 2011AA ObjectClass-2)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)

RadiationSurgeryAdministeredBeginDate

Item

Date (dd MMM yyyy)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
C0439659 (UMLS 2011AA ValueDomain-2)
C15696 (NCI Thesaurus ObjectClass)
C0085203 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)

RadiationTherapyTotalDoseText

Item

Total Dose (Gy)

text

C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C25304 (NCI Thesaurus Property)
C0439810 (UMLS 2011AA Property)
C25488 (NCI Thesaurus Property-2)
C0178602 (UMLS 2011AA Property-2)
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25304 (NCI Thesaurus ValueDomain-2)
C0439810 (UMLS 2011AA ValueDomain-2)
C25488 (NCI Thesaurus ValueDomain-3)
C0178602 (UMLS 2011AA ValueDomain-3)

SBRT Fraction 2

Item Group

Sbrt Fraction (1)

FractionationRadiationTherapyAdministeredInd-2

Item

Was fraction delivered (check one)

boolean

RadiationSurgeryAdministeredBeginDate

Item

Date (dd MMM yyyy)

date

RadiationTherapyTotalDoseText

Item

Total Dose (Gy)

text

SBRT Fraction 3

Item Group

Sbrt Fraction (1)

FractionationRadiationTherapyAdministeredInd-2

Item

Was fraction delivered (check one)

boolean

RadiationSurgeryAdministeredBeginDate

Item

Date (dd MMM yyyy)

date

RadiationTherapyTotalDoseText

Item

Total Dose (Gy)

text

Unscheduled Interruptions

Item Group

Stereotactic Body Radiation Therapy

Unscheduled Interruptions in Radiation Therapy

Item

Were there any unscheduled interruptions in radiation therapy? (stereotactic body check one)

boolean

C25180 (NCI Thesaurus ValueDomain)
C1522449 (UMLS CUI-1)
C15313 (NCI Thesaurus ObjectClass)
C1512900 (UMLS CUI-2)
C25542 (NCI Thesaurus Property)

TreatmentModifiedDoseBeginDate

Item

Treatment interruption start date (If yes dd MMM yyyy)

date

C15368 (NCI Thesaurus ObjectClass)
C25256 (NCI Thesaurus Property)
C1265611 (UMLS 2011AA Property)
C25573 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
C0439659 (UMLS 2011AA ValueDomain-2)

TreatmentModifiedRestartDoseBeginDate

Item

Treatment interruption end date (If yes dd MMM yyyy)

date

C15368 (NCI Thesaurus ObjectClass)
C25256 (NCI Thesaurus Property)
C1265611 (UMLS 2011AA Property)
C25573 (NCI Thesaurus Property-2)
C25658 (NCI Thesaurus Property-3)
C1514902 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
C0439659 (UMLS 2011AA ValueDomain-2)

TreatmentInterruptionDayDuration

Item

Days Treatment Was Interrupted (number)

float

C25301 (NCI Thesaurus ValueDomain)
C0439228 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25330 (NCI Thesaurus ValueDomain-2)
C0449238 (UMLS 2011AA ValueDomain-2)
C25542 (NCI Thesaurus Property)
C1512900 (UMLS 2011AA Property)

RTUnscheduledInterruptionReason

Item

Reasons

text

C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C25542 (NCI Thesaurus Property)
C1512900 (UMLS 2011AA Property)

CL.24

Code List

Reasons

CL Item

Social (Social)

CL Item

Skin Reaction (Skin reaction)

CL Item

Systemic Reaction (Systemic reaction)

CL Item

Machine Down (Machine down)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

CL Item

Anc (ANC)

CL Item

Platelets (Platelets)

CL Item

Febrile Neutropenia (Febrile neutropenia)

C0746883 (NCI Metathesaurus)

CL Item

Dysphagia (Dysphagia)

E10621 (CTCAE)

CL Item

Other Nonhematologic (Other nonhematologic)

CL Item

Other Specify (other)

Radiation Therapy Interruption Reason

Item

Specify

text

C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS CUI-1)
C25594 (NCI Thesaurus Property)
C3538832 (UMLS CUI-2)
C25211 (NCI Thesaurus Property-2)
C25542 (NCI Thesaurus Property-3)
C25685 (NCI Thesaurus ValueDomain)

TreatmentInterruptionType

Item

Due to

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25542 (NCI Thesaurus Property)
C1512900 (UMLS 2011AA Property)

CL.25

Code List

Due to

CL Item

Chemotherapy (Chemotherapy)

C15632 (NCI Thesaurus)
C0392920 (UMLS 2011AA)

CL Item

Radiotherapy (Radiotherapy)

CL Item

Combination Therapy (Combination Therapy)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
C17649 (NCI Thesaurus-3)
C0205394 (UMLS 2011AA-4)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

RadiationTherapyInterruptionSpecify

Item

Other specify

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C25542 (NCI Thesaurus Property)
C1512900 (UMLS 2011AA Property)

QualityAssuranceCenterSubmissionInd-2

Item

Have all Stereotactic Body Radiation Therapy Quality Assurance documentation and imaging materials been submitted to the Image-guided Therapy Center (SBRT see Section 5.4.3 ITC check one)

boolean

Footer Module

Item Group

Footer Module

Research Comments

Item

Comments

text

C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)

RadiationOncologistLastName

Item

Radiation Oncologist's Name, Last (PRINT)

text

C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C17833 (NCI Thesaurus ObjectClass)
C1514693 (UMLS 2011AA ObjectClass)
C25551 (NCI Thesaurus ValueDomain-2)
C1517741 (UMLS 2011AA ValueDomain-2)
C40975 (NCI Thesaurus Property)
C1301584 (UMLS 2011AA Property)

RadiationOncologistFirstName

Item

Radiation Oncologist's Name, First (PRINT)

text

C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25509 (NCI Thesaurus ValueDomain-2)
C1279901 (UMLS 2011AA ValueDomain-2)
C17833 (NCI Thesaurus ObjectClass)
C1514693 (UMLS 2011AA ObjectClass)
C40974 (NCI Thesaurus Property)
C1443235 (UMLS 2011AA Property)

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Lung Cancer NCT01336894 Treatment - ACOSOG-Z4099 Evaluation/Treatment Form - 3181065v1.0

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