ID

10501

Description

Treatment Form 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=A65C8791-5AF1-42A8-E034-0003BA0B1A09

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A65C8791-5AF1-42A8-E034-0003BA0B1A09

Keywords

Versions (3)
  1. 9/20/12 9/20/12 -
  2. 6/2/15 6/2/15 -
  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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Treatment Form NCT00058149

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

Arm A
Description

Arm A

Cycle Number
Description

CycleNumber

Data type

text

Oxaliplatin Dose (mg)
Description

AgentTotalDose

Data type

float

Oxaliplatin begin date (M D Y)
Description

AgentBeginDate

Data type

date

Arm B
Description

Arm B

Arm C
Description

Arm C

If yes, choose one:
Description

DoseModification(Change)

Data type

text

Name of therapy
Description

TherapyModificationName

Data type

text

Type of therapy modification
Description

TherapyModificationText

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25572
Reason for therapy modification
Description

DoseModificationReason

Data type

text

Non-protocol Therapy
Description

Non-protocol Therapy

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

Non-ProtocolTherapyInd,DuringProtocol

Data type

boolean

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

Patient Weight
Description

PatientWeight

Data type

float

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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
Item Group
Arm A
CycleNumber
Item
Cycle Number
text
AgentTotalDose
Item
Oxaliplatin Dose (mg)
float
AgentBeginDate
Item
Oxaliplatin begin date (M D Y)
date
Item Group
Arm B
Item Group
Arm C
Item
If yes, choose one:
text
CL.5
Code List
If yes, choose one:
CL Item
(i.e., The Treatment Was Changed According To Protocol Guidelines) (Planned (i.e., the treatment was changed according to protocol guidelines))
CL Item
(i.e., The Treatment Change Was Not Part Of Protocol Guidelines) (Unplanned (i.e., the treatment change was not part of protocol guidelines))
CL Item
Both planned and unplanned, specify unplanned changes above (Both planned and unplanned, specify unplanned changes above)
TherapyModificationName
Item
Name of therapy
text
TherapyModificationText
Item
Type of therapy modification
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25572 (NCI Thesaurus Property)
DoseModificationReason
Item
Reason for therapy modification
text
Item Group
Non-protocol Therapy
Non-ProtocolTherapyInd,DuringProtocol
Item
Was any non-protocol therapy given during protocol treatment (not previously reported)?
boolean
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
PatientWeight
Item
Patient Weight
float
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