INSTRUCTIONS: Submit this form at patient's entry on study. Use -1 for unknown or not applicable unless otherwise specified in the codetable. All dates to be reported mm-dd-yyyy unless otherwise indicated.

1 Formulaires

StudyEvent: I1 Radiation Therapy Oncology Group Phase III Randomized Study of Adjuvant Therapy for High Risk pT3NO Prostate Cancer Initial Evaluation Form
1. INSTRUCTIONS: Submit this form at patient's entry on study. Use -1 for unknown or not applicable unless otherwise specified in the codetable. All dates to be reported mm-dd-yyyy unless otherwise indicated.

Name

Type

Description | Question | Decode (Coded Value)

Type de données

Alias

Header

Item Group

Header

RTOGStudy

Item

RTOG Study

text

Case#

Item

Case #

text

InstitutionName

Item

Institution Name

text

InstitutionNo.

Item

Institution No.

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)

PatientName,Last

Item

Patient Name, Last

text

PatientName,First

Item

Patient Name, First

text

AmendedData

Item

AMENDED DATA

text

Comments

Item

COMMENTS

text

Signature

Item

Signature

text

Date

Item

Date

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)

Patient data

Item Group

Patient data

PatientBirthDate

Item

PATIENT BIRTH DATE (2)

date

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)

PERFORMANCESTATUS

Item

PERFORMANCE STATUS (3)

text

CL.1

Code List

PERFORMANCE STATUS (3)

CL Item

0 (0)

C0919414 (NCI Metathesaurus)

CL Item

1 (1)

CL Item

2 (2)

C66833 (NCI Thesaurus)
C0205448 (UMLS 2011AA)

CL Item

3 (3)

CL Item

4 (4)

CL Item

-1 (-1)

HASPATIENTHADANOTHERMALIGNANCY

Item

HAS PATIENT HAD ANOTHER MALIGNANCY (other than study site)

boolean

C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)

SpecifySite(malignancyotherthanstudysite)

Item

Specify Site (malignancy other than study site)

text

DATEERADICATED

Item

DATE ERADICATED (mm/yyyy If not NED from second malignancy, leave date blank.)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C20985 (NCI Thesaurus Property)
C0547070 (UMLS 2011AA Property)

FirstPositiveBiopsyDate

Item

DATE OF INITIAL DIAGNOSIS OF PRIMARY TUMOR (5 HISTOPATHOLOGIC TYPE)

date

HistologicType

Item

HISTOLOGIC TYPE

text

CL.3

Code List

HISTOLOGIC TYPE

CL Item

Adenocarcinoma_2005009 (Adenocarcinoma)

CL Item

Other_specify_2005013 (Other, specify)

CL Item

Unknown or not applicable (Unknown or not applicable)

Other,specify(histologictype)

Item

Other, specify (histologic type) (B)

text

GleasonScore,PrimaryPattern

Item

GLEASON SCORE, PRIMARY PATTERN ([most frequently seen] 1-5, 9=unknown)

float

GleasonScore,SecondaryPattern

Item

GLEASON SCORE, SECONDARY PATTERN ([second most frequently seen] 1-5, 9=unknown)

float

GleasonScore,WorstPattern

Item

GLEASON SCORE, WORST PATTERN ([worst pathological grade seen in any specimen] 1-5, 9=unknown)

float

GleasonScore,Combined

Item

GLEASON SCORE, COMBINED ([sum of the primary and secondary, unless unknown] 99=Unknown)

float

ALKALINEPHOSPHATASE

Item

ALKALINE PHOSPHATASE

text

CL.18

Code List

ALKALINE PHOSPHATASE

CL Item

Not Done (Not done)

CL281691 (NCI Metathesaurus)

CL Item

Normal (Normal)

C14165 (NCI Thesaurus)
C0205307 (UMLS 2011AA)

CL Item

Abnormal, Elevated (Abnormal, elevated)

CL Item

Abnormal, < Normal (Abnormal, < normal)

AlkPhosValue

Item

Alk Phos Value

float

SPECIFY(unitofmeasure)

Item

SPECIFY (unit of measure)

text

CL.19

Code List

SPECIFY (unit of measure)

CL Item

U/ml (u/ml)

CL Item

U/l (u/l)

Labnormalrange(alkalinephosphatase)

Item

Lab normal range (alkaline phosphatase) (B)

text

ALT(SGPT)

Item

ALT (SGPT)

text

CL.20

Code List

ALT (SGPT)

CL Item

Not Done (Not done)

CL281691 (NCI Metathesaurus)

CL Item

Normal (Normal)

C14165 (NCI Thesaurus)
C0205307 (UMLS 2011AA)

CL Item

Abnormal, Elevated (Abnormal, elevated)

CL Item

Abnormal, < Normal (Abnormal, < normal)

ALTValue

Item

ALT Value

float

ALT Normal Range

Item

Lab normal range (ALT) (C)

text

C25294 (NCI Thesaurus ObjectClass)
C20200 (NCI Thesaurus Property)
C25293 (NCI Thesaurus Property-2)
C25704 (NCI Thesaurus ValueDomain)
C14165 (NCI Thesaurus ValueDomain-2)
C38013 (NCI Thesaurus ValueDomain-3)
C0376147 (UMLS CUI-1)
C0086715 (UMLS CUI-2)

TOTALBILIRUBIN

Item

TOTAL BILIRUBIN

text

CL.21

Code List

TOTAL BILIRUBIN

CL Item

Not Done (Not done)

CL281691 (NCI Metathesaurus)

CL Item

Normal (Normal)

C14165 (NCI Thesaurus)
C0205307 (UMLS 2011AA)

CL Item

Abnormal, Elevated (Abnormal, elevated)

CL Item

Abnormal, < Normal (Abnormal, < normal)

TotalBilirubinValue

Item

Total Bilirubin Value

float

C25209 (NCI Thesaurus ValueDomain)
C1278039 (UMLS CUI-1)

Labnormalrange(totalbilirubin)

Item

Lab normal range (total bilirubin) (11 BASELINE PSA VALUE)

text

BaselinePSADate

Item

Baseline PSA Date

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)

BaselinePSAValue

Item

Baseline PSA Value

float

C0138741 (UMLS CUI-1)

TIMEPOINT

Item

TIME POINT (12 GU DYSFUNCTION AT STUDY ENTRY Use CTC 2.0 to code severity)

text

CL.22

Code List

TIME POINT (12 GU DYSFUNCTION AT STUDY ENTRY Use CTC 2.0 to code severity)

CL Item

Pre-surgery (Pre-surgery)

CL Item

Post-surgery (Post-surgery)

CL Item

Study Entry (Study entry)

CL Item

Pre-hormone (Pre-hormone)

URINARYINCONTINENCE,SeverityGrade

Item

URINARY INCONTINENCE, Severity Grade (0-3)

text

CL.23

Code List

URINARY INCONTINENCE, Severity Grade (0-3)

CL Item

0 (0)

C0919414 (NCI Metathesaurus)

CL Item

1 (1)

CL Item

2 (2)

C66833 (NCI Thesaurus)
C0205448 (UMLS 2011AA)

CL Item

3 (3)

URINARYINCONTINENCE,Attribution

Item

URINARY INCONTINENCE, Attribution

text

CL.24

Code List

URINARY INCONTINENCE, Attribution

CL Item

Not Applicable (Not applicable)

C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)

CL Item

Surgical (Surgical)

C25698 (NCI Thesaurus)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

Other(attribution,urinaryincontinence)

Item

Other (attribution, urinary incontinence)

text

URINARYFREQUENCY/URGENCY,SeverityGrade

Item

URINARY FREQUENCY/URGENCY, Severity Grade (0-3)

text

CL.25

Code List

URINARY FREQUENCY/URGENCY, Severity Grade (0-3)

CL Item

0 (0)

C0919414 (NCI Metathesaurus)

CL Item

1 (1)

CL Item

2 (2)

C66833 (NCI Thesaurus)
C0205448 (UMLS 2011AA)

CL Item

3 (3)

URINARYFREQUENCY/URGENCY,Attribution

Item

URINARY FREQUENCY/URGENCY, Attribution

text

CL.26

Code List

URINARY FREQUENCY/URGENCY, Attribution

CL Item

Not Applicable (Not applicable)

C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)

CL Item

Surgical (Surgical)

C25698 (NCI Thesaurus)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

Other(attribution,urinaryfrequency/urgency)

Item

Other (attribution, urinary frequency/urgency)

text

ERECTILEIMPOTENCE,SeverityGrade

Item

ERECTILE IMPOTENCE, Severity Grade (0-3)

text

CL.27

Code List

ERECTILE IMPOTENCE, Severity Grade (0-3)

CL Item

0 (0)

C0919414 (NCI Metathesaurus)

CL Item

1 (1)

CL Item

2 (2)

C66833 (NCI Thesaurus)
C0205448 (UMLS 2011AA)

CL Item

3 (3)

ERECTILEIMPOTENCE,Attribution

Item

ERECTILE IMPOTENCE, Attribution

text

CL.28

Code List

ERECTILE IMPOTENCE, Attribution

CL Item

Not Applicable (Not applicable)

C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)

CL Item

Surgical (Surgical)

C25698 (NCI Thesaurus)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

Other(erectileimpotence)

Item

Other (erectile impotence) (13)

text

TStage,Pathologic

Item

T STAGE, PATHOLOGIC (14A)

text

CL.29

Code List

T STAGE, PATHOLOGIC (14A)

CL Item

T2, Tumor Confined Within The Prostate (see Ajcc Definition) (T2, NOS)

CL Item

T2a, Tumor Confined Within The Prostate (see Ajcc Definition) (T2a)

CL Item

T2b, Tumor Confined Within The Prostate (see Ajcc Definition) (T2b)

CL Item

T3, Tumor Extends Through The Prostatic Capsule (see Ajcc Definition) (T3, NOS)

CL Item

T3a, Tumor Extends Through The Prostatic Capsule (see Ajcc Definition) (T3a)

CL Item

T3b, Tumor Extends Through The Prostatic Capsule (see Ajcc Definition) (T3b)

CL Item

T4, Tumor Is Fixed Or Invades Adjacent Structures (see Ajcc Definition) (T4)

CL Item

Primary Tumor Cannot Be Assessed (TX)

NStage,Pathologic

Item

N STAGE, PATHOLOGIC (SURGICAL)

text

CL.30

Code List

N STAGE, PATHOLOGIC (SURGICAL)

CL Item

No Regional Lymph Node Metastasis (N0)

CL Item

Metastatis In Regional Lymph Node Or Nodes (see Ajcc Definition) (N1)

CL Item

No node sampling (No node sampling)

NStage,Clinical

Item

N STAGE, CLINICAL (RADIOGRAPHIC)

text

CL.31

Code List

N STAGE, CLINICAL (RADIOGRAPHIC)

CL Item

No Regional Lymph Node Metastasis (N0)

CL Item

Metastasis To Movable Ipsilateral Axillary Lymph Node(s) (N1)

CL Item

Regional Lymph Nodes Cannot Be Assessed (e.g., Previously Removed) (NX)

ROACHRISKCALCULATION

Item

ROACH RISK CALCULATION (15)

text

CL.32

Code List

ROACH RISK CALCULATION (15)

CL Item

<15% (<15%)

CL Item

>=15% (>=15%)

MStage,Clinical

Item

M STAGE, CLINICAL

text

CL.33

Code List

M STAGE, CLINICAL

CL Item

No Distant Metastasis (M0)

CL Item

Distant Metastasis (M1)

C18206 (NCI Thesaurus)
C1269798 (UMLS 2011AA)

CL Item

Nonregional Lymph Node(s) (M1a)

CL Item

Bone(s) (M1b)

CL Item

Other Site(s) (M1c)

CL Item

Distant Metastsis Cannot Be Assessed (MX)

PRIOR TREATMENT

Item Group

Prostate: Prior Treatment

C1514463 (UMLS CUI-1)

PriorProstatectomyInd

Item

PRIOR PROSTATECTOMY

boolean

PriorProstatectomyDate

Item

Prior prostatectomy date

date

POSITIVESURGICALMARGINS

Item

POSITIVE SURGICAL MARGINS

boolean

C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)

SEMINALVESICLEINVASION

Item

SEMINAL VESICLE INVASION (pathologic)

boolean

C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)

PRIORRADIATIONTHERAPY

Item

PRIOR RADIATION THERAPY

boolean

C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)

Specify(priorradiationtherapy)

Item

Specify (prior radiation therapy) (8)

text

PRIORCHEMOTHERAPY

Item

PRIOR CHEMOTHERAPY (for any reason)

boolean

C25180 (NCI Thesaurus ValueDomain)
C1514457 (UMLS CUI-1)

PriorChemotherapyEndDate

Item

Prior chemotherapy end date (9)

date

PRIORHORMONALTHERAPY

Item

PRIOR HORMONAL THERAPY (A)

boolean

C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)

PRIORHORMONALTHERAPYTYPEFINASTERIDE

Item

PRIOR HORMONAL THERAPY TYPE FINASTERIDE

boolean

C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)

PriorHormonalTherapyEndDate

Item

Prior hormonal therapy end date (C)

date

PRIORHORMONALTHERAPYTYPETESTOSTERONE

Item

PRIOR HORMONAL THERAPY TYPE TESTOSTERONE

boolean

C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)

PRIOROTHERHORMONALTHERAPY

Item

PRIOR OTHER HORMONAL THERAPY

boolean

C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)

Specify(priorotherhormonaltherapy)

Item

Specify (prior other hormonal therapy)

text

PriorOtherHormonalTherapyBeginDate

Item

Date prior other hormonal therapy started (D)

date

ORCHIECTOMY

Item

ORCHIECTOMY

boolean

C25180 (NCI Thesaurus ValueDomain)
C0029189 (UMLS CUI-1)

OrchiectomyDate

Item

Orchiectomy date

date

C25164 (NCI Thesaurus ValueDomain)
C15288 (NCI Thesaurus ObjectClass)
C25275 (NCI Thesaurus Property)
C0029189 (UMLS CUI-1)
C0011008 (UMLS CUI-2)

Alternative medicine

Item

PRIOR OR CURRENT COMPLEMENTARY ALTERNATIVE MEDICINE (CAM) THERAPY

boolean

C25180 (NCI Thesaurus ValueDomain)
C0002346 (UMLS CUI-1)

Alternative medicine, specify

Item

Specify (prior or current complementary alternative medicine therapy)

text

DatepriororcurrentCAMtherapystarted

Item

Date prior or current CAM therapy started

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)

PriorCAMtherapyenddate

Item

Prior CAM therapy end date (if continuing leave blank)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)

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