ID

2857

Beschrijving

Treatment Form Gemcitabine With or Without Radiation Therapy in Treating Patients With Pancreatic Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A626A4B2-8496-3D7F-E034-0003BA0B1A09

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A626A4B2-8496-3D7F-E034-0003BA0B1A09

Trefwoorden

Versies (3)
  1. 19-09-12 19-09-12 -
  2. 01-06-15 01-06-15 -
  3. 03-06-15 03-06-15 -
Geüploaded op

19 september 2012

DOI

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Licentie

Creative Commons BY-NC 3.0 Legacy
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Pancreatic Cancer NCT00057876 Treatment - Treatment Form - 2047986v3.0

Engels

No Instruction available.

1 Formulieren  
  1. StudyEvent: Treatment Form
    1. No Instruction available.
Unnamed1
Beschrijving

Unnamed1

Registration Step
Beschrijving

RegistrationStep

Datatype

text

Patient?s Name
Beschrijving

Patient'sName

Datatype

text

ECOG Protocol No.
Beschrijving

ECOGProtocolNo.

Datatype

text

ECOG Protocol No.
Beschrijving

ECOGProtocolNo.

Datatype

text

ECOG Patient ID
Beschrijving

ECOGPatientID

Datatype

text

ECOG Patient ID
Beschrijving

ECOGPatientID

Datatype

text

Participating Group Protocol No.
Beschrijving

ParticipatingGroupProtocolNo.

Datatype

text

Participating Group Patient ID
Beschrijving

ParticipatingGroupPatientID

Datatype

text

Institution/Affiliate
Beschrijving

MainMemberInstitution/Affiliate

Datatype

text

Unnamed2
Beschrijving

Unnamed2

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

AmendedDataInd

Datatype

text

Alias
NCI Thesaurus ObjectClass
C25474
UMLS 2011AA ObjectClass
C1511726
NCI Thesaurus Property
C25416
UMLS 2011AA Property
C1691222
Vital Status
Beschrijving

Vital Status

Patient?s Vital Status
Beschrijving

Patient'sVitalStatus

Datatype

text

Date of Last Contact or Death (M D Y)
Beschrijving

DeathDate/LastContactDate

Datatype

date

Cause of Death (if applicable)
Beschrijving

Causeofdeath

Datatype

text

Describe cause of death
Beschrijving

DeathReason,Specify

Datatype

text

Assigned Treatment Arm
Beschrijving

ProtocolTreatmentArmAssignmentText

Datatype

text

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass
C42651
UMLS 2011AA ObjectClass
C0442711
NCI Thesaurus Property
C32141
UMLS 2011AA Property
C1140618
NCI Thesaurus Property
C25426
UMLS 2011AA Property
C1516050
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
Induction
Beschrijving

Induction

Gemcitabine start date
Beschrijving

TreatmentStartDate

Datatype

date

Last date (any modality of) protocol therapy was given
Beschrijving

TreatmentEndDate

Datatype

date

Total agent dose
Beschrijving

AgentTotalDose

Datatype

double

RT Begin Date
Beschrijving

RTBeginDate

Datatype

date

RT End Date
Beschrijving

RTEndDate

Datatype

date

RT Total Dose (cGy)
Beschrijving

RTTotalDose

Datatype

double

Were there any dose modifications or additions/omissions to protocol treatment? (Choose one:)
Beschrijving

DoseModification(Change)

Datatype

text

Were there any unscheduled interruptions in radiation therapy?
Beschrijving

RTInterruptionsInd

Datatype

text

Yes, for other reasons, specify (RT Interruptions)
Beschrijving

RTInterruptionsReason

Datatype

text

Consolidation
Beschrijving

Consolidation

Total number of cycles given (consolidation only)
Beschrijving

TotalCourseNumber

Datatype

double

Gemcitabine start date
Beschrijving

TreatmentStartDate

Datatype

date

Last date (any modality of) protocol therapy was given
Beschrijving

TreatmentEndDate

Datatype

date

Last date (any modality of) protocol therapy was given
Beschrijving

TreatmentEndDate

Datatype

date

Total agent dose
Beschrijving

AgentTotalDose

Datatype

double

Was any non-protocol therapy given during protocol treatment? (not previously reported)
Beschrijving

Non-ProtocolTherapyInd,DuringTreatment

Datatype

text

Were there any dose modifications or additions/omissions to protocol treatment? (Choose one:)
Beschrijving

DoseModification(Change)

Datatype

text

Reason Treatment Ended (Choose one)
Beschrijving

OffTreatmentReason

Datatype

text

Specify complicating disease (reason treatment ended)
Beschrijving

OffTreatmentReason,ComplicatingDisease

Datatype

text

Specify other Reasons (reason treatment ended)
Beschrijving

OffTreatmentReason,Other

Datatype

text

Comments
Beschrijving

Comments

Comments
Beschrijving

Comments

Datatype

text

Investigator Signature
Beschrijving

InvestigatorSignature

Datatype

text

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

InvestigatorSignatureDate

Datatype

date

Ccrr Module For Treatment Form
Beschrijving

Ccrr Module For Treatment Form

Agent start date
Beschrijving

AgentBeginDate

Datatype

date

Agent end date
Beschrijving

AgentEndDate

Datatype

date

Total agent dose
Beschrijving

AgentTotalDose

Datatype

double

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Similar models

No Instruction available.

1 Formulieren
  1. StudyEvent: Treatment Form
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Unnamed1
RegistrationStep
Item
Registration Step
text
Patient'sName
Item
Patient?s Name
text
ECOGProtocolNo.
Item
ECOG Protocol No.
text
ECOGProtocolNo.
Item
ECOG Protocol No.
text
ECOGPatientID
Item
ECOG Patient ID
text
ECOGPatientID
Item
ECOG Patient ID
text
ParticipatingGroupProtocolNo.
Item
Participating Group Protocol No.
text
ParticipatingGroupPatientID
Item
Participating Group Patient ID
text
MainMemberInstitution/Affiliate
Item
Institution/Affiliate
text
Item Group
Unnamed2
Item
Are data amended? (If yes, please circle amended items in red)
text
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25416 (NCI Thesaurus Property)
C1691222 (UMLS 2011AA Property)
CL.1
Code List
Are data amended? (If yes, please circle amended items in red)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item Group
Vital Status
Item
Patient?s Vital Status
text
CL.2
Code List
Patient?s Vital Status
CL Item
Alive (Alive)
CL Item
Dead (Dead)
DeathDate/LastContactDate
Item
Date of Last Contact or Death (M D Y)
date
Item
Cause of Death (if applicable)
text
CL.3
Code List
Cause of Death (if applicable)
CL Item
Due To Protocol Treatment (Due to protocol treatment)
CL Item
Due To This Disease (Due to this disease)
CL Item
Due To Other Cause (Due to other cause)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
DeathReason,Specify
Item
Describe cause of death
text
ProtocolTreatmentArmAssignmentText
Item
Assigned Treatment Arm
text
C15368 (NCI Thesaurus ObjectClass)
C42651 (NCI Thesaurus ObjectClass)
C0442711 (UMLS 2011AA ObjectClass)
C32141 (NCI Thesaurus Property)
C1140618 (UMLS 2011AA Property)
C25426 (NCI Thesaurus Property)
C1516050 (UMLS 2011AA Property)
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
Item Group
Induction
TreatmentStartDate
Item
Gemcitabine start date
date
TreatmentEndDate
Item
Last date (any modality of) protocol therapy was given
date
AgentTotalDose
Item
Total agent dose
double
RTBeginDate
Item
RT Begin Date
date
RTEndDate
Item
RT End Date
date
RTTotalDose
Item
RT Total Dose (cGy)
double
Item
Were there any dose modifications or additions/omissions to protocol treatment? (Choose one:)
text
CL.6
Code List
Were there any dose modifications or additions/omissions to protocol treatment? (Choose one:)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
(i.e., The Treatment Was Changed According To Protocol Guidelines) (Yes, planned)
CL Item
(i.e., The Treatment Change Was Not Part Of Protocol Guidelines) (Yes, unplanned)
CL Item
Yes, both planned and unplanned (Yes, both planned and unplanned)
Item
Were there any unscheduled interruptions in radiation therapy?
text
CL.5
Code List
Were there any unscheduled interruptions in radiation therapy?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes, Due To Toxicity (Yes, due to toxicity)
CL Item
Yes, For Other Reasons, Specify (Yes, for other reasons, specify)
RTInterruptionsReason
Item
Yes, for other reasons, specify (RT Interruptions)
text
Item Group
Consolidation
TotalCourseNumber
Item
Total number of cycles given (consolidation only)
double
TreatmentStartDate
Item
Gemcitabine start date
date
TreatmentEndDate
Item
Last date (any modality of) protocol therapy was given
date
TreatmentEndDate
Item
Last date (any modality of) protocol therapy was given
date
AgentTotalDose
Item
Total agent dose
double
Item
Was any non-protocol therapy given during protocol treatment? (not previously reported)
text
CL.7
Code List
Was any non-protocol therapy given during protocol treatment? (not previously reported)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Were there any dose modifications or additions/omissions to protocol treatment? (Choose one:)
text
CL.6
Code List
Were there any dose modifications or additions/omissions to protocol treatment? (Choose one:)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
(i.e., The Treatment Was Changed According To Protocol Guidelines) (Yes, planned)
CL Item
(i.e., The Treatment Change Was Not Part Of Protocol Guidelines) (Yes, unplanned)
CL Item
Yes, both planned and unplanned (Yes, both planned and unplanned)
Item
Reason Treatment Ended (Choose one)
text
CL.8
Code List
Reason Treatment Ended (Choose one)
CL Item
Treatment Completed Per Protocol Criteria (Treatment completed per protocol criteria)
CL Item
Disease Progression, Relapse During Active Treatment (Disease progression, relapse during active treatment)
CL Item
Toxicity/side Effects/complications (Toxicity/side effects/complications)
CL Item
Death After Beginning Protocol Therapy (Death after beginning protocol therapy)
CL Item
Patient Withdrawal Or Refusal After Beginning Protocol Therapy (Patient withdrawal or refusal after beginning protocol therapy)
CL Item
Alternative Therapy (Alternative therapy)
CL Item
Patient Off-treatment For Other Complicating Disease (Other complicating disease)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
OffTreatmentReason,ComplicatingDisease
Item
Specify complicating disease (reason treatment ended)
text
OffTreatmentReason,Other
Item
Specify other Reasons (reason treatment ended)
text
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 Treatment Form
AgentBeginDate
Item
Agent start date
date
AgentEndDate
Item
Agent end date
date
AgentTotalDose
Item
Total agent dose
double
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