ID

10530

Description

Treatment Form NCT00057876 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

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

To request one please log in.

License

Creative Commons BY-NC 3.0 Legacy
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Treatment Form NCT00057876

English

No Instruction available.

1 forms  
  1. StudyEvent: Treatment Form
    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

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
Vital Status
Description

Vital Status

Patient?s Vital Status
Description

Patient'sVitalStatus

Data type

text

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

DeathDate/LastContactDate

Data type

date

Cause of Death (if applicable)
Description

Causeofdeath

Data type

text

Describe cause of death
Description

DeathReason,Specify

Data type

text

Assigned Treatment Arm
Description

ProtocolTreatmentArmAssignmentText

Data type

text

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass-2
C42651
UMLS 2011AA ObjectClass
C0442711
NCI Thesaurus Property
C32141
UMLS 2011AA Property
C1140618
NCI Thesaurus Property-2
C25426
UMLS 2011AA Property-2
C1516050
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
Induction
Description

Induction

Gemcitabine start date
Description

TreatmentStartDate

Data type

date

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

TreatmentEndDate

Data type

date

Total agent dose
Description

AgentTotalDose

Data type

float

RT Begin Date
Description

RTBeginDate

Data type

date

RT End Date
Description

RTEndDate

Data type

date

RT Total Dose (cGy)
Description

RTTotalDose

Data type

float

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

DoseModification(Change)

Data type

text

Were there any unscheduled interruptions in radiation therapy?
Description

RTInterruptionsInd

Data type

text

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

RTInterruptionsReason

Data type

text

Consolidation
Description

Consolidation

Total number of cycles given (consolidation only)
Description

TotalCourseNumber

Data type

float

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

Non-ProtocolTherapyInd,DuringTreatment

Data type

boolean

Reason Treatment Ended (Choose one)
Description

OffTreatmentReason

Data type

text

Specify complicating disease (reason treatment ended)
Description

OffTreatmentReason,ComplicatingDisease

Data type

text

Specify other Reasons (reason treatment ended)
Description

OffTreatmentReason,Other

Data type

text

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 Treatment Form
Description

Ccrr Module For Treatment Form

Agent start date
Description

AgentBeginDate

Data type

date

Agent end date
Description

AgentEndDate

Data type

date

Back to the top of the page

Similar models

No Instruction available.

1 forms
  1. StudyEvent: Treatment Form
    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
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
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-2)
C0442711 (UMLS 2011AA ObjectClass)
C32141 (NCI Thesaurus Property)
C1140618 (UMLS 2011AA Property)
C25426 (NCI Thesaurus Property-2)
C1516050 (UMLS 2011AA Property-2)
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
float
RTBeginDate
Item
RT Begin Date
date
RTEndDate
Item
RT End Date
date
RTTotalDose
Item
RT Total Dose (cGy)
float
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)
float
Non-ProtocolTherapyInd,DuringTreatment
Item
Was any non-protocol therapy given during protocol treatment? (not previously reported)
boolean
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
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial