ID

10522

Description

Follow-Up Disease Evaluation Form (RECIST) NCT00058149 A Phase III, Randomized Study of Gemcitabine (Fixed-Dose Rate Infusion) and Oxaliplatin (NSC 266046) Versus Gemcitabine (Fixed-Dose Rate Infusion) Versus Gemcitabine (30-Minute Infusion) in Pancreatic Carcinoma Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A6868BEA-ECA3-53E6-E034-0003BA0B1A09

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A6868BEA-ECA3-53E6-E034-0003BA0B1A09

Keywords

Versions (3)
  1. 9/19/12 9/19/12 -
  2. 6/1/15 6/1/15 -
  3. 6/3/15 6/3/15 -
Uploaded on

June 3, 2015

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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Follow-Up Disease Evaluation Form (RECIST) NCT00058149

English

No Instruction available.

1 forms  
  1. StudyEvent: Follow-Up Disease Evaluation Form (RECIST)
    1. No Instruction available.
ECOG clinical trial administrative data
Description

ECOG clinical trial administrative data

ECOG Protocol No.
Description

ECOGProtocolNo.

Data type

text

ECOG Patient ID
Description

ECOGPatientID

Data type

text

Registration Step
Description

RegistrationStep

Data type

text

Cycle Number (leave blank if off-treatment or N/A)
Description

CycleNumber

Data type

text

Patient?s Name
Description

Patient'sName

Data type

text

Participating Group Protocol No.
Description

ParticipatingGroupProtocolNo.

Data type

text

Participating Group Patient ID
Description

ParticipatingGroupPatientID

Data type

text

Institution/Affiliate
Description

MainMemberInstitution/Affiliate

Data type

text

Are data amended? (If yes, please circle amended items in red)
Description

AmendedDataInd

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C25474
UMLS 2011AA ObjectClass
C1511726
NCI Thesaurus Property
C25416
UMLS 2011AA Property
C1691222
Target Lesions:
Description

Target Lesions:

Lesion Number
Description

Lesion,ReferenceNumber

Data type

float

Site of Lesion (Multiple new lesions within an organ may be combined as a single site.)
Description

Lesion,AnatomicSite

Data type

text

Site Code
Description

LesionMeasurableEvaluationAnatomicSite

Data type

text

Alias
NCI Thesaurus ValueDomain
C13717
UMLS 2011AA ValueDomain
C1515974
NCI Thesaurus ObjectClass
C3824
UMLS 2011AA ObjectClass
C0221198
NCI Thesaurus Property
C25214
UMLS 2011AA Property
C0220825
NCI Thesaurus Property-2
C37894
UMLS 2011AA Property-2
C1513040
Method of Evaluation
Description

AssessmentType

Data type

text

Date of Evaluation (M D Y)
Description

AssessmentDate

Data type

date

Longest Diameter of Lesion(s) (cm)
Description

Lesion,TumorDiameter

Data type

float

Alias
NCI Thesaurus ValueDomain
C25209
UMLS 2011AA ValueDomain
C0242485
For Identification: Document BASELINE Longest Diameter of Lesion (cm)
Description

BaselineLongestDiameterofLesion(cm)

Data type

text

Sum of longest diameters of all target lesions (cm)
Description

Lesion,Diameter,LongestSum

Data type

float

Nontarget Lesions:
Description

Nontarget Lesions:

Follow-Up Status of Lesions
Description

Follow-UpStatusofLesions

Data type

text

Cytology Result (For Site Code 04 effusion/ascites ONLY)
Description

CytologyResult

Data type

text

Alias
NCI Thesaurus ObjectClass
C16491
UMLS 2011AA ObjectClass
C0010819
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
Unequivocal progressive disease in nontarget lesions is based on: (please describe)
Description

ProgressiveDiseaseNon-TargetLesionDescriptionText

Data type

text

Alias
NCI Thesaurus ObjectClass
C35571
UMLS 2011AA ObjectClass
C1335499
NCI Thesaurus Property
C3824
UMLS 2011AA Property
C0221198
NCI Thesaurus Property-2
C25592
UMLS 2011AA Property-2
C1518389
NCI Thesaurus Property-3
C25365
UMLS 2011AA Property-3
C0678257
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
New Lesions
Description

New Lesions

Was the appearance of any new lesions documented?
Description

NewLesionInd

Data type

text

Response Of Target Lesions This Reporting Period
Description

Response Of Target Lesions This Reporting Period

Has the response of the target lesions changed, OR has an unconfirmed response changed to a confirmed response, since last report?
Description

Hastheresponseofthetargetlesionschanged,ORhasanunconfirmedresponsechangedtoaconfirmedresponse,sincelastreport?

Data type

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
Response status at this assessment (target lesions)
Description

ResponseCriteria

Data type

text

PR/CR first observed date (M D Y)
Description

PR/CRFirstObservedDate

Data type

text

Alias
NCI Thesaurus Property
C18212
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus Property-2
C4870
UMLS 2011AA Property
C0677874
NCI Thesaurus Property-3
C25599
UMLS 2011AA Property-2
C1441672
Progressive disease observed date (For PD:)
Description

ProgressiveDiseaseObservedDate

Data type

date

Overall Response Per Recist Criteria - Target, Nontarget And New Lesions
Description

Overall Response Per Recist Criteria - Target, Nontarget And New Lesions

Has the overall response changed, OR has an unconfirmed response changed to a confirmed response, since last report?
Description

Hastheoverallresponsechanged,ORhasanunconfirmedresponsechangedtoaconfirmedresponse,sincelastreport?

Data type

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
Overall response status at this assessment
Description

OverallTumorResponse

Data type

text

Has response been confirmed by second assessment? (Confirmation of response: For CR/PR, all assessments repeated >= 4 wks after onset of CR/PR.)
Description

ResponseConfirmedInd

Data type

boolean

Symptomatic Deterioration
Description

Symptomatic Deterioration

Is there symptomatic deterioration of the patient's health status requiring discontinuation of treatment (this reporting period)?
Description

SymptomaticDeteriorationInd

Data type

text

yes, specify
Description

SymptomaticDeteriorationSpecify

Data type

text

Symptomatic Deterioration Date (M D Y)
Description

SymptomaticDeteriorationDate

Data type

date

Comments
Description

Comments

Comments
Description

Comments

Data type

text

Investigator Signature
Description

InvestigatorSignature

Data type

text

Alias
NCI Thesaurus Property
C25678
UMLS 2011AA Property
C1519316
NCI Thesaurus ObjectClass
C17089
UMLS 2011AA ObjectClass
C0035173
Date
Description

InvestigatorSignatureDate

Data type

date

Ccrr Module For Follow-up Disease Evaluation Form (recist)
Description

Ccrr Module For Follow-up Disease Evaluation Form (recist)

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Similar models

No Instruction available.

1 forms
  1. StudyEvent: Follow-Up Disease Evaluation Form (RECIST)
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
ECOG clinical trial administrative data
ECOGProtocolNo.
Item
ECOG Protocol No.
text
ECOGPatientID
Item
ECOG Patient ID
text
RegistrationStep
Item
Registration Step
text
CycleNumber
Item
Cycle Number (leave blank if off-treatment or N/A)
text
Patient'sName
Item
Patient?s Name
text
ParticipatingGroupProtocolNo.
Item
Participating Group Protocol No.
text
ParticipatingGroupPatientID
Item
Participating Group Patient ID
text
MainMemberInstitution/Affiliate
Item
Institution/Affiliate
text
AmendedDataInd
Item
Are data amended? (If yes, please circle amended items in red)
boolean
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25416 (NCI Thesaurus Property)
C1691222 (UMLS 2011AA Property)
Item Group
Target Lesions:
Lesion,ReferenceNumber
Item
Lesion Number
float
Lesion,AnatomicSite
Item
Site of Lesion (Multiple new lesions within an organ may be combined as a single site.)
text
Item
Site Code
text
C13717 (NCI Thesaurus ValueDomain)
C1515974 (UMLS 2011AA ValueDomain)
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C37894 (NCI Thesaurus Property-2)
C1513040 (UMLS 2011AA Property-2)
CL.9
Code List
Site Code
CL Item
Bone (Bone)
C12366 (NCI Thesaurus)
C0262950 (UMLS 2011AA)
CL Item
Brain (Brain)
C12439 (NCI Thesaurus)
C0006104 (UMLS 2011AA)
CL Item
Breast (Breast)
C12971 (NCI Thesaurus)
C0006141 (UMLS 2011AA)
CL Item
Effusion/ascites (Effusion/Ascites)
CL Item
Gi (GI)
CL Item
Gu (GU)
CL Item
Head & Neck (Head & Neck)
CL Item
Liver (Liver)
C12392 (NCI Thesaurus)
C0023884 (UMLS 2011AA)
CL Item
Lung (Lung)
C12468 (NCI Thesaurus)
C0024109 (UMLS 2011AA)
CL Item
Nodes (Nodes)
CL Item
Skin (Skin)
C12470 (NCI Thesaurus)
C1123023 (UMLS 2011AA)
CL Item
Other (specify Site) (Other (specify site))
Item
Method of Evaluation
text
CL.10
Code List
Method of Evaluation
CL Item
Clinical Examination (Clinical Exam)
CL Item
Chest X-ray (Chest X-Ray)
CL Item
Ct Scan (CT Scan (non-spiral))
CL Item
Spiral Ct Scan (Spiral CT)
CL Item
Mri (MRI)
CL Item
Ultrasound (Ultrasound)
C64384 (NCI Thesaurus)
C1456803 (UMLS 2011AA)
CL Item
Bone Scan (Bone scan)
C17646 (NCI Thesaurus)
C0203668 (UMLS 2011AA)
CL Item
Not Evaluated (Not evaluated)
CL Item
Other (Other (specify in Comments))
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
AssessmentDate
Item
Date of Evaluation (M D Y)
date
Lesion,TumorDiameter
Item
Longest Diameter of Lesion(s) (cm)
float
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
BaselineLongestDiameterofLesion(cm)
Item
For Identification: Document BASELINE Longest Diameter of Lesion (cm)
text
Lesion,Diameter,LongestSum
Item
Sum of longest diameters of all target lesions (cm)
float
Item Group
Nontarget Lesions:
Item
Follow-Up Status of Lesions
text
CL.6
Code List
Follow-Up Status of Lesions
CL Item
Cr (CR)
CL Item
Incompl. Resp./sd (incompl. resp./SD)
CL Item
Pd (PD)
Item
Cytology Result (For Site Code 04 effusion/ascites ONLY)
text
C16491 (NCI Thesaurus ObjectClass)
C0010819 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
CL.11
Code List
Cytology Result (For Site Code 04 effusion/ascites ONLY)
CL Item
Negative (Negative)
C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)
CL Item
Positive (Positive)
C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)
CL Item
Not Done (Not done)
CL281691 (NCI Metathesaurus)
ProgressiveDiseaseNon-TargetLesionDescriptionText
Item
Unequivocal progressive disease in nontarget lesions is based on: (please describe)
text
C35571 (NCI Thesaurus ObjectClass)
C1335499 (UMLS 2011AA ObjectClass)
C3824 (NCI Thesaurus Property)
C0221198 (UMLS 2011AA Property)
C25592 (NCI Thesaurus Property-2)
C1518389 (UMLS 2011AA Property-2)
C25365 (NCI Thesaurus Property-3)
C0678257 (UMLS 2011AA Property-3)
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
Item Group
New Lesions
Item
Was the appearance of any new lesions documented?
text
CL.8
Code List
Was the appearance of any new lesions documented?
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (yes, record below)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item Group
Response Of Target Lesions This Reporting Period
Item
Has the response of the target lesions changed, OR has an unconfirmed response changed to a confirmed response, since last report?
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
CL.12
Code List
Has the response of the target lesions changed, OR has an unconfirmed response changed to a confirmed response, since last report?
CL Item
No (no, skip to Overall Response)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Response status at this assessment (target lesions)
text
CL.13
Code List
Response status at this assessment (target lesions)
CL Item
Complete Response (CR (confirmed or unconfirmed))
CL Item
Partial Response (PR (confirmed or unconfirmed))
C18212 (NCI Thesaurus)
CL Item
Stable Disease (SD)
C18213 (NCI Thesaurus)
C0677946 (UMLS 2011AA)
CL Item
Progressive Disease Or Progression (PD)
CL Item
Insufficient Evaluation (Insufficient evaluation to determine response status (unknown))
PR/CRFirstObservedDate
Item
PR/CR first observed date (M D Y)
text
C18212 (NCI Thesaurus Property)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C4870 (NCI Thesaurus Property-2)
C0677874 (UMLS 2011AA Property)
C25599 (NCI Thesaurus Property-3)
C1441672 (UMLS 2011AA Property-2)
ProgressiveDiseaseObservedDate
Item
Progressive disease observed date (For PD:)
date
Item Group
Overall Response Per Recist Criteria - Target, Nontarget And New Lesions
Item
Has the overall response changed, OR has an unconfirmed response changed to a confirmed response, since last report?
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
CL.14
Code List
Has the overall response changed, OR has an unconfirmed response changed to a confirmed response, since last report?
CL Item
No (no, skip this section)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Overall response status at this assessment
text
CL.15
Code List
Overall response status at this assessment
CL Item
Complete Response (CR (confirmed or unconfirmed))
CL Item
Partial Response (PR (confirmed or unconfirmed))
C18212 (NCI Thesaurus)
CL Item
Stable Disease (SD)
C18213 (NCI Thesaurus)
C0677946 (UMLS 2011AA)
CL Item
Progressive Disease (PD)
C35571 (NCI Thesaurus)
C1335499 (UMLS 2011AA)
CL Item
Null (Insufficient evaluation to determine response status (unknown))
ResponseConfirmedInd
Item
Has response been confirmed by second assessment? (Confirmation of response: For CR/PR, all assessments repeated >= 4 wks after onset of CR/PR.)
boolean
Item Group
Symptomatic Deterioration
Item
Is there symptomatic deterioration of the patient's health status requiring discontinuation of treatment (this reporting period)?
text
CL.17
Code List
Is there symptomatic deterioration of the patient's health status requiring discontinuation of treatment (this reporting period)?
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (yes, specify)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
SymptomaticDeteriorationSpecify
Item
yes, specify
text
SymptomaticDeteriorationDate
Item
Symptomatic Deterioration Date (M D Y)
date
Item Group
Comments
Comments
Item
Comments
text
InvestigatorSignature
Item
Investigator Signature
text
C25678 (NCI Thesaurus Property)
C1519316 (UMLS 2011AA Property)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)
InvestigatorSignatureDate
Item
Date
date
Item Group
Ccrr Module For Follow-up Disease Evaluation Form (recist)
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