ID

44666

Description

TF: Radiation Therapy Oncology Group Phase III Esophagus Systemic Treatment Summary Form Paclitaxel, Cisplatin, and Radiation Therapy With or Without Cetuximab in Treating Patients With Locally Advanced Esophageal Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=2A02FE34-6EF5-5B5C-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=2A02FE34-6EF5-5B5C-E044-0003BA3F9857

Keywords

  1. 9/19/12 9/19/12 -
  2. 1/9/15 1/9/15 - Martin Dugas
  3. 1/9/15 1/9/15 - Martin Dugas
  4. 1/29/19 1/29/19 -
  5. 9/27/21 9/27/21 -
Copyright Holder

NCI

Uploaded on

September 27, 2021

DOI

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License

Creative Commons BY-NC 3.0

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Esophageal Cancer NCT00655876 Treatment - TF: Radiation Therapy Oncology Group Phase III Esophagus Systemic Treatment Summary Form - 2598533v1.0

No Instruction available.

  1. StudyEvent: TF: Radiation Therapy Oncology Group Phase III Esophagus Systemic Treatment Summary Form
    1. No Instruction available.
Module 1
Description

Module 1

RTOG Study No.
Description

Protocol ID RTOG

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C1514695
NCI Thesaurus Property
C19778
NCI Thesaurus Property-2
C25364
Case #
Description

RadiationTherapyOncologyGroupPatientCaseIdentifierNumber

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ObjectClass-2
C19778
UMLS 2011AA ObjectClass-2
C1514695
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property-2
C49152
UMLS 2011AA Property-2
C1706256
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
Institution
Description

Institution Name

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C1301943
NCI Thesaurus ObjectClass
C21541
NCI Thesaurus ValueDomain-2
C21541
NCI Thesaurus Property
C25364
Institution No.
Description

Institution Number

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1301943
NCI Thesaurus ObjectClass
C21541
UMLS CUI-2
C0805701
NCI Thesaurus Property
C25364
Patient Initials
Description

Patient Initials

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
RTOG Patient ID
Description

Trial subject ID RTOG

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C1514695
NCI Thesaurus Property
C19778
NCI Thesaurus Property-2
C25364
AMENDED DATA
Description

Data amended

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C0680532
NCI Thesaurus ObjectClass
C25474
NCI Thesaurus Property
C25416
Patient Characteristics
Description

Patient Characteristics

Height (cm)
Description

Patient Height

Data type

float

Measurement units
  • cm
Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0489786
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25347
cm
Weight (kg)
Description

Patient Weight

Data type

float

Measurement units
  • Kg
Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0005910
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25208
Kg
BSA (m2)
Description

Body Surface Area

Data type

float

Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0005902
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25157
Was dose modified due to weight loss
Description

AgentWeightLossDoseModificationInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus Property
C3445
UMLS 2011AA Property
C1262477
NCI Thesaurus Property-2
C25488
UMLS 2011AA Property-2
C0178602
NCI Thesaurus Property-3
C25572
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Day the dose was modified
Description

AgentWeightLossDoseModificationPeriodType

Data type

text

Alias
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus Property
C3445
UMLS 2011AA Property
C1262477
NCI Thesaurus Property-2
C25488
UMLS 2011AA Property-2
C0178602
NCI Thesaurus Property-3
C25572
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ValueDomain-2
C25616
UMLS 2011AA ValueDomain-2
C1948053
Unnamed Module 1
Description

Unnamed Module 1

Agent Name
Description

Agent

Data type

text

Alias
NCI Thesaurus Property
C25364
UMLS CUI-1
C1521826
NCI Thesaurus ObjectClass
C1708
NCI Thesaurus ValueDomain
C1708
NCI Thesaurus ValueDomain-2
C42614
Agent Start Date
Description

Medication Start Date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1521826
NCI Thesaurus ValueDomain-2
C25431
UMLS CUI-2
C0808070
NCI Thesaurus ObjectClass
C1708
NCI Thesaurus Property
C25275
Agent End Date
Description

Medication End Date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1521826
NCI Thesaurus ObjectClass
C1708
UMLS CUI-2
C0806020
NCI Thesaurus Property
C25275
Total No. of Doses
Description

Number of Doses, Total

Data type

float

Alias
NCI Thesaurus Property
C25304
UMLS CUI-1
C0178602
NCI Thesaurus ValueDomain
C25463
UMLS CUI-2
C0750480
NCI Thesaurus ObjectClass
C1708
NCI Thesaurus Property-2
C25256
Day #1
Description

AgentFirstDayFirstWeekAdministeredDose

Data type

float

Alias
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus Property
C25301
UMLS 2011AA Property
C0439228
NCI Thesaurus Property-2
C25509
UMLS 2011AA Property-2
C1279901
NCI Thesaurus Property-3
C29844
UMLS 2011AA Property-3
C0439230
NCI Thesaurus Property-4
C25382
UMLS 2011AA Property-4
C1521801
NCI Thesaurus ValueDomain
C25488
UMLS 2011AA ValueDomain
C0178602
NCI Thesaurus ValueDomain-2
C1708
UMLS 2011AA ValueDomain-2
C0450442
Day #8
Description

AgentFirstDaySecondWeekAdministeredDose

Data type

float

Alias
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus Property
C25301
UMLS 2011AA Property
C0439228
NCI Thesaurus Property-2
C25509
UMLS 2011AA Property-2
C1279901
NCI Thesaurus Property-3
C25666
UMLS 2011AA Property-3
C0205436
NCI Thesaurus Property-4
C29844
UMLS 2011AA Property-4
C0439230
NCI Thesaurus Property-5
C25382
UMLS 2011AA Property-5
C1521801
NCI Thesaurus ValueDomain
C25488
UMLS 2011AA ValueDomain
C0178602
NCI Thesaurus ValueDomain-2
C1708
UMLS 2011AA ValueDomain-2
C0450442
Day #15
Description

AgentFirstDayThirdWeekAdministeredDose

Data type

float

Alias
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus Property
C25301
UMLS 2011AA Property
C0439228
NCI Thesaurus Property-2
C25509
UMLS 2011AA Property-2
C1279901
NCI Thesaurus Property-3
C29844
UMLS 2011AA Property-3
C0439230
NCI Thesaurus Property-4
C25260
UMLS 2011AA Property-4
C0205437
NCI Thesaurus Property-5
C25382
UMLS 2011AA Property-5
C1521801
NCI Thesaurus ValueDomain
C25488
UMLS 2011AA ValueDomain
C0178602
NCI Thesaurus ValueDomain-2
C1708
UMLS 2011AA ValueDomain-2
C0450442
Day #22
Description

AgentFirstDayFourthWeekAdministeredDose

Data type

float

Alias
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus Property
C25301
UMLS 2011AA Property
C0439228
NCI Thesaurus Property-2
C25509
UMLS 2011AA Property-2
C1279901
NCI Thesaurus Property-3
C29844
UMLS 2011AA Property-3
C0439230
NCI Thesaurus Property-4
C25382
UMLS 2011AA Property-4
C1521801
NCI Thesaurus Property-5
C54566
UMLS 2011AA Property-5
C0205438
NCI Thesaurus ValueDomain
C25488
UMLS 2011AA ValueDomain
C0178602
NCI Thesaurus ValueDomain-2
C1708
UMLS 2011AA ValueDomain-2
C0450442
Day #29
Description

AgentFirstDayFifthWeekAdministeredDose

Data type

float

Alias
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus Property
C25301
UMLS 2011AA Property
C0439228
NCI Thesaurus Property-2
C25509
UMLS 2011AA Property-2
C1279901
NCI Thesaurus Property-3
C29844
UMLS 2011AA Property-3
C0439230
NCI Thesaurus Property-4
C25382
UMLS 2011AA Property-4
C1521801
NCI Thesaurus Property-5
C54567
UMLS 2011AA Property-5
C0205439
NCI Thesaurus ValueDomain
C25488
UMLS 2011AA ValueDomain
C0178602
NCI Thesaurus ValueDomain-2
C1708
UMLS 2011AA ValueDomain-2
C0450442
Day #36
Description

AgentFirstDaySixthWeekAdministeredDose

Data type

float

Alias
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus Property
C25301
UMLS 2011AA Property
C0439228
NCI Thesaurus Property-2
C25509
UMLS 2011AA Property-2
C1279901
NCI Thesaurus Property-3
C29844
UMLS 2011AA Property-3
C0439230
NCI Thesaurus Property-4
C25382
UMLS 2011AA Property-4
C1521801
NCI Thesaurus Property-5
C54568
UMLS 2011AA Property-5
C0205440
NCI Thesaurus ValueDomain
C25488
UMLS 2011AA ValueDomain
C0178602
NCI Thesaurus ValueDomain-2
C1708
UMLS 2011AA ValueDomain-2
C0450442
Agent Total Cumulative Dose
Description

Cumulative Dose Agent

Data type

float

Alias
NCI Thesaurus ObjectClass
C1708
UMLS CUI-1
C2986497
NCI Thesaurus ObjectClass-2
C25470
UMLS CUI-2
C1521826
NCI Thesaurus Property
C25304
NCI Thesaurus Property-2
C25256
NCI Thesaurus ValueDomain
C25304
NCI Thesaurus ValueDomain-2
C25488
Units
Description

Units

Data type

text

Alias
NCI Thesaurus ObjectClass
C1708
UMLS CUI-1
C1519795
NCI Thesaurus Property
C25256
NCI Thesaurus ValueDomain
C25709
Were there any dose modifications or additions/omissions to protocol treatment?
Description

Dose Modification

Data type

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS CUI-1
C1707811
NCI Thesaurus ObjectClass
C25256
NCI Thesaurus Property
C25572
NCI Thesaurus ValueDomain-2
C25572
Reason Treatment Ended
Description

Off Treatment Reason

Data type

text

Alias
NCI Thesaurus ValueDomain
C25638
UMLS CUI-1
C1518544
NCI Thesaurus ObjectClass
C25601
UMLS CUI-2
C0566251
NCI Thesaurus Property
C25365
Alternative therapy, specify alternative therapy
Description

Alternative therapy, specify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS CUI-1
C0949216
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass-2
C25415
NCI Thesaurus Property
C25382
Other specify
Description

Off Treatment Reason, specify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS CUI-1
C1518544
NCI Thesaurus ObjectClass
C25601
UMLS CUI-2
C0566251
NCI Thesaurus Property
C25365
UMLS CUI-3
C1521902
Report All Continuing Or New Adverse Events
Description

Report All Continuing Or New Adverse Events

MedDRA Code
Description

MedDRACode

Data type

float

Alias
NCI Thesaurus ValueDomain
C25162
UMLS 2011AA ValueDomain
C0805701
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Metathesaurus ObjectClass
CL104089
MedDRA Code
Description

MedDRACode

Data type

float

Alias
NCI Thesaurus ValueDomain
C25162
UMLS 2011AA ValueDomain
C0805701
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Metathesaurus ObjectClass
CL104089
CTC AE Term
Description

CTC Adverse Event Term

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C1516728
NCI Thesaurus ObjectClass
C49704
UMLS CUI-2
C2826934
NCI Thesaurus Property
C45559
CTC AE Grade
Description

CTC Adverse Event Grade

Data type

float

Alias
NCI Thesaurus ObjectClass
C49704
UMLS CUI-1
C2985911
NCI Thesaurus ValueDomain
C18000
NCI Thesaurus Property
C25365
CTCAE Begin Date
Description

CTCAdverseEventReportBeginDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C25375
UMLS 2011AA Property
C0684224
NCI Thesaurus ValueDomain-2
C25431
UMLS 2011AA ValueDomain-2
C0439659
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
Adverse Event Reporting to Date
Description

CTCAdverseEventReportEndDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C25375
UMLS 2011AA Property
C0684224
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
CTC Adverse Event Attribution (Attribution to Protocol Treatment See protocol sections 6 & 7 for definition of "protocol treatment")
Description

CTC Adverse Event Attribution Category

Data type

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS CUI-1
C1706735
NCI Thesaurus ObjectClass
C49704
NCI Thesaurus Property
C25358
Has an AdEERS been filed
Description

AdverseEventReportInd-3

Data type

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25375
UMLS 2011AA Property
C0684224
NCI Thesaurus ObjectClass-2
C17648
UMLS 2011AA ObjectClass-2
C0439064
Was this SAE per NCI definitions
Description

NationalCancerInstituteDefinitionSeriousAdverseEventPresentInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C41335
UMLS 2011AA ObjectClass
C1519255
NCI Thesaurus ObjectClass-2
C19202
UMLS 2011AA ObjectClass-2
C1513882
NCI Thesaurus ObjectClass-3
C42777
UMLS 2011AA ObjectClass-3
C1704788
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Is there a reasonable possibility that the event may have been caused by the investigational agent
Description

RelatedAdverseEventInvestigationalRegimenInd-3

Data type

text

Alias
NCI Thesaurus ObjectClass
C25648
UMLS 2011AA ObjectClass
C0439849
NCI Thesaurus ObjectClass-2
C41331
UMLS 2011AA ObjectClass-2
C0877248
NCI Thesaurus Property
C28041
UMLS 2011AA Property
C1517586
NCI Thesaurus Property-2
C15697
UMLS 2011AA Property-2
C0040808
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Action taken regarding study therapy
Description

ProtocolAgentDoseAdverseEventModificationStatus

Data type

text

Alias
NCI Thesaurus ObjectClass
C25488
UMLS 2011AA ObjectClass
C0178602
NCI Thesaurus ObjectClass-2
C41161
UMLS 2011AA ObjectClass-2
C1521826
NCI Thesaurus Property
C41331
UMLS 2011AA Property
C0877248
NCI Thesaurus Property-2
C25572
NCI Thesaurus ValueDomain
C25688
UMLS 2011AA ValueDomain
C0449438
Treatment required
Description

AdverseEventTherapeuticProcedureAdministeredType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus ObjectClass-2
C49236
UMLS 2011AA ObjectClass-2
C0087111
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Present Status
Description

Adverse Event Outcome

Data type

text

Alias
NCI Thesaurus Property
C25626
UMLS CUI-1
C1705586
NCI Thesaurus ObjectClass
C41331
NCI Thesaurus ValueDomain
C25688
Report All Continuing Or New Adverse Events
Description

Report All Continuing Or New Adverse Events

New or continuing adverse events
Description

Adverse Event

Data type

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C0877248
NCI Thesaurus ObjectClass
C25586
NCI Thesaurus ObjectClass-2
C41331
NCI Thesaurus Property
C25275
MedDRA Code
Description

MedDRACode

Data type

float

Alias
NCI Thesaurus ValueDomain
C25162
UMLS 2011AA ValueDomain
C0805701
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Metathesaurus ObjectClass
CL104089
CTC AE Term
Description

CTC Adverse Event Term

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C1516728
NCI Thesaurus ObjectClass
C49704
UMLS CUI-2
C2826934
NCI Thesaurus Property
C45559