ID

10957

Description

E3201 Surgery Form NCT00068692 Comparison of Adjuvant Chemotherapy Regimens in Treating Patients With Stage II or Stage III Rectal Cancer Who Are Receiving Radiation Therapy and Fluorouracil Before or After Surgery Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=B5522261-773C-6D97-E034-0003BA12F5E7

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=B5522261-773C-6D97-E034-0003BA12F5E7

Keywords

Versions (3)
  1. 8/27/12 8/27/12 -
  2. 1/9/15 1/9/15 - Martin Dugas
  3. 6/16/15 6/16/15 -
Uploaded on

June 16, 2015

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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E3201 Surgery Form NCT00068692

English

No Instruction available.

1 forms  
  1. StudyEvent: E3201 Surgery Form
    1. No Instruction available.
Header
Description

Header

ECOG Protocol Number
Description

Protocol Number ECOG

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C1512162
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25491
ECOG Patient ID
Description

Patient ID ECOG

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C1512162
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25491
Registration Step
Description

Registration Number

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1514821
NCI Thesaurus ObjectClass
C25646
UMLS CUI-2
C0237753
NCI Thesaurus Property
C16154
NCI Thesaurus ValueDomain-2
C16154
Time Period
Description

TimePeriod

Data type

text

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
Participating Group Protocol No.
Description

Study Number Participating Group

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C2347449
NCI Thesaurus Property
C25608
NCI Thesaurus Property-2
C25364
Participating Group Patient ID
Description

Trial subject ID Participating Group

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C2347449
NCI Thesaurus Property
C25608
NCI Thesaurus Property-2
C25364
Institution/Affiliate
Description

Institution Name

Data type

text

Alias
NCI Thesaurus ObjectClass
C25454
UMLS CUI-1
C1301943
NCI Thesaurus ObjectClass-2
C21541
NCI Thesaurus Property
C25364
NCI Thesaurus ValueDomain
C25191
NCI Thesaurus ValueDomain-2
C21541
Are data amended? (If yes, please circle amended items in red)
Description

Data amended

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C0680532
NCI Thesaurus ObjectClass
C25474
NCI Thesaurus Property
C25416
Surgery assessment
Description

Surgery assessment

Patient Group
Description

Protocol Treatment Arm

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1522541
NCI Thesaurus Property
C32141
NCI Thesaurus ObjectClass
C15368
Planned Surgery Type
Description

PlannedSurgeryType

Data type

text

other, specify (surgery)
Description

other,specify(surgery)

Data type

text

Pre-surgery tumor distance from the anal verge
Description

Pre-surgerytumordistancefromtheanalverge

Data type

text

Rectal tumor status
Description

Rectaltumorstatus

Data type

text

Did patient undergo surgical resection?
Description

Didpatientundergosurgicalresection?

Data type

boolean

Reason surgery not performed
Description

Reasonsurgerynotperformed

Data type

text

Surgery date
Description

SurgeryDate

Data type

date

Do surgery results qualify patient for further protocol therapy?
Description

ProtocolSurgery,QualifyingResultsInd

Data type

boolean

Primary surgery type
Description

SarcomaPrimarySurgicalProcedurePerformedType

Data type

text

Alias
NCI Thesaurus ObjectClass
C25251
UMLS 2011AA ObjectClass
C0205225
NCI Thesaurus ObjectClass-2
C15329
UMLS 2011AA ObjectClass-2
C0543467
NCI Thesaurus ObjectClass-3
C9118
UMLS 2011AA ObjectClass-3
C1261473
NCI Thesaurus Property
C25251
UMLS 2011AA Property
C0205225
NCI Thesaurus Property-2
C38000
UMLS 2011AA Property-2
C0884358
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
other, specify (surgery)
Description

PrimarySurgery,OtherType

Data type

text

Was sphincter preserved?
Description

ColorectalSurgicalProcedureSphincterPreservedInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C13363
UMLS 2011AA ObjectClass
C0555952
NCI Thesaurus ObjectClass-2
C15329
UMLS 2011AA ObjectClass-2
C0543467
NCI Thesaurus Property
C28381
UMLS 2011AA Property
C1409894
NCI Metathesaurus Property
C0456735
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Was there bowel perforation?
Description

PerforationInd

Data type

boolean

Was there bowel obstruction?
Description

ObstructionInd

Data type

boolean

Was there tumor spillage?
Description

TumorSpillageInd

Data type

boolean

Were all lymph nodes suggestive of disease removed?
Description

LymphNodesRemovedInd

Data type

boolean

Was a complete resection done?
Description

PriorSurgicalResectionInd

Data type

boolean

Was completion of an en bloc resection of the primary tumor documented?
Description

EnBlocResectionInd

Data type

text

Alias
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus ObjectClass
C15232
UMLS 2011AA ObjectClass
C0728940
NCI Thesaurus ObjectClass-2
C25733
UMLS 2011AA ObjectClass-2
C1516835
Did the primary tumor adhere to or invade an adjacent organ?
Description

TumorAdherenceInd

Data type

boolean

Specify organs
Description

Specifyorgans

Data type

text

Number of lymph nodes examined
Description

LymphNode(s)ExaminedNumber

Data type

float

Alias
NCI Thesaurus Property
C25500
UMLS 2011AA Property
C0332128
NCI Thesaurus ObjectClass
C12745
UMLS 2011AA ObjectClass
C0024204
Number of lymph nodes removed
Description

Numberoflymphnodesremoved

Data type

text

Distance from the tumor to distal bowel
Description

DistancetoDistalBowel

Data type

float

Alias
NCI Thesaurus ValueDomain
C25209
UMLS 2011AA ValueDomain
C0242485
Distance from the tumor to proximal bowel
Description

DistancetoProximalBowel

Data type

float

Alias
NCI Thesaurus ValueDomain
C25209
UMLS 2011AA ValueDomain
C0242485
Have the radial margins been documented as grossly free of disease?
Description

RadialMarginsDiseaseFreeGrossInd

Data type

boolean

Have the radial margins been documented as histologically free of disease?
Description

RadialMarginsDiseaseFreeMicroInd

Data type

boolean

Type of anastomosis
Description

Typeofanastomosis

Data type

text

Was anastomosis stapled?
Description

Wasanastomosisstapled?

Data type

boolean

Was a pouch created?
Description

Wasapouchcreated?

Data type

boolean

Length of pouch
Description

Lengthofpouch

Data type

text

Tumor Statging
Description

Tumor Statging

Pathologic T stage
Description

ColorectalTumorPathologicTStage

Data type

text

Alias
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus ObjectClass-2
C13363
UMLS 2011AA ObjectClass-2
C0555952
NCI Thesaurus Property
C25610
UMLS 2011AA Property
C1521733
NCI Thesaurus Property-2
C25728
UMLS 2011AA Property-2
C0475455
NCI Thesaurus ValueDomain
C16899
UMLS 2011AA ValueDomain
C1300072
Pathologic N Stage
Description

NStage,Pathologic

Data type

text

Pathologic M Stage
Description

ColorectalTumorPathologicMStage

Data type

text

Alias
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus ObjectClass-2
C13363
UMLS 2011AA ObjectClass-2
C0555952
NCI Thesaurus Property
C25610
UMLS 2011AA Property
C1521733
NCI Thesaurus Property-2
C25727
UMLS 2011AA Property-2
C0456533
NCI Thesaurus ValueDomain
C16899
UMLS 2011AA ValueDomain
C1300072
Comments
Description

Comments

Comments
Description

Research Comments

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0947611
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
Investigator Signature
Description

InvestigatorSignature

Data type

text

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

Investigator Signature Date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C2346576
NCI Thesaurus Property
C25678
UMLS CUI-2
C0011008
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus ObjectClass
C17089
Ccrr Module For E3201 Surgery Form
Description

Ccrr Module For E3201 Surgery Form

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No Instruction available.

1 forms
  1. StudyEvent: E3201 Surgery Form
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header
Protocol Number ECOG
Item
ECOG Protocol Number
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (NCI Thesaurus Property-2)
Patient ID ECOG
Item
ECOG Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (NCI Thesaurus Property-2)
Registration Number
Item
Registration Step
text
C25337 (NCI Thesaurus ValueDomain)
C1514821 (UMLS CUI-1)
C25646 (NCI Thesaurus ObjectClass)
C0237753 (UMLS CUI-2)
C16154 (NCI Thesaurus Property)
C16154 (NCI Thesaurus ValueDomain-2)
Item
Time Period
text
CL.1
Code List
Time Period
CL Item
One month post surgery (One month post surgery)
CL Item
Study entry (Study entry)
Patient Initials
Item
Patient Initials
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Study Number Participating Group
Item
Participating Group Protocol No.
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Trial subject ID Participating Group
Item
Participating Group Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Institution Name
Item
Institution/Affiliate
text
C25454 (NCI Thesaurus ObjectClass)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
C25191 (NCI Thesaurus ValueDomain)
C21541 (NCI Thesaurus ValueDomain-2)
Data amended
Item
Are data amended? (If yes, please circle amended items in red)
boolean
C38148 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)
Item Group
Surgery assessment
Item
Patient Group
text
C25337 (NCI Thesaurus ValueDomain)
C1522541 (UMLS CUI-1)
C32141 (NCI Thesaurus Property)
C15368 (NCI Thesaurus ObjectClass)
CL.3
Code List
Patient Group
CL Item
Group I (Group I)
CL Item
Group II (Group II)
Item
Planned Surgery Type
text
CL.4
Code List
Planned Surgery Type
CL Item
Low Anterior Resection (low anterior resection)
CL Item
Abdominal Perineal Resection (abdominal perineal resection)
CL Item
Low Anterior Resection/coloanal Anastomosis (low anterior resection/coloanal anastomosis)
CL Item
Other, Specify (other, specify)
other,specify(surgery)
Item
other, specify (surgery)
text
Pre-surgerytumordistancefromtheanalverge
Item
Pre-surgery tumor distance from the anal verge
text
Item
Rectal tumor status
text
CL.5
Code List
Rectal tumor status
CL Item
Fixed (fixed)
CL Item
Tethered (tethered)
CL Item
Mobile (mobile)
C25295 (NCI Thesaurus)
C0231435 (UMLS 2011AA)
Didpatientundergosurgicalresection?
Item
Did patient undergo surgical resection?
boolean
Reasonsurgerynotperformed
Item
Reason surgery not performed
text
SurgeryDate
Item
Surgery date
date
ProtocolSurgery,QualifyingResultsInd
Item
Do surgery results qualify patient for further protocol therapy?
boolean
Item
Primary surgery type
text
C25251 (NCI Thesaurus ObjectClass)
C0205225 (UMLS 2011AA ObjectClass)
C15329 (NCI Thesaurus ObjectClass-2)
C0543467 (UMLS 2011AA ObjectClass-2)
C9118 (NCI Thesaurus ObjectClass-3)
C1261473 (UMLS 2011AA ObjectClass-3)
C25251 (NCI Thesaurus Property)
C0205225 (UMLS 2011AA Property)
C38000 (NCI Thesaurus Property-2)
C0884358 (UMLS 2011AA Property-2)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.8
Code List
Primary surgery type
CL Item
Low Anterior Resection (low anterior resection)
CL Item
Abdominal Perineal Resection (abdominal perineal resection)
CL Item
Low Anterior Resection/coloanal Anastomosis (low anterior resection/coloanal anastomosis)
CL Item
Other, Specify (other, specify)
PrimarySurgery,OtherType
Item
other, specify (surgery)
text
ColorectalSurgicalProcedureSphincterPreservedInd-2
Item
Was sphincter preserved?
boolean
C13363 (NCI Thesaurus ObjectClass)
C0555952 (UMLS 2011AA ObjectClass)
C15329 (NCI Thesaurus ObjectClass-2)
C0543467 (UMLS 2011AA ObjectClass-2)
C28381 (NCI Thesaurus Property)
C1409894 (UMLS 2011AA Property)
C0456735 (NCI Metathesaurus Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PerforationInd
Item
Was there bowel perforation?
boolean
ObstructionInd
Item
Was there bowel obstruction?
boolean
TumorSpillageInd
Item
Was there tumor spillage?
boolean
LymphNodesRemovedInd
Item
Were all lymph nodes suggestive of disease removed?
boolean
PriorSurgicalResectionInd
Item
Was a complete resection done?
boolean
Item
Was completion of an en bloc resection of the primary tumor documented?
text
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C15232 (NCI Thesaurus ObjectClass)
C0728940 (UMLS 2011AA ObjectClass)
C25733 (NCI Thesaurus ObjectClass-2)
C1516835 (UMLS 2011AA ObjectClass-2)
CL.15
Code List
Was completion of an en bloc resection of the primary tumor documented?
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
TumorAdherenceInd
Item
Did the primary tumor adhere to or invade an adjacent organ?
boolean
Specifyorgans
Item
Specify organs
text
LymphNode(s)ExaminedNumber
Item
Number of lymph nodes examined
float
C25500 (NCI Thesaurus Property)
C0332128 (UMLS 2011AA Property)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
Numberoflymphnodesremoved
Item
Number of lymph nodes removed
text
DistancetoDistalBowel
Item
Distance from the tumor to distal bowel
float
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
DistancetoProximalBowel
Item
Distance from the tumor to proximal bowel
float
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
RadialMarginsDiseaseFreeGrossInd
Item
Have the radial margins been documented as grossly free of disease?
boolean
RadialMarginsDiseaseFreeMicroInd
Item
Have the radial margins been documented as histologically free of disease?
boolean
Item
Type of anastomosis
text
CL.19
Code List
Type of anastomosis
CL Item
End-to-end (end-to-end)
CL Item
End-to-side (end-to-side)
Wasanastomosisstapled?
Item
Was anastomosis stapled?
boolean
Wasapouchcreated?
Item
Was a pouch created?
boolean
Lengthofpouch
Item
Length of pouch
text
Item Group
Tumor Statging
Item
Pathologic T stage
text
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C13363 (NCI Thesaurus ObjectClass-2)
C0555952 (UMLS 2011AA ObjectClass-2)
C25610 (NCI Thesaurus Property)
C1521733 (UMLS 2011AA Property)
C25728 (NCI Thesaurus Property-2)
C0475455 (UMLS 2011AA Property-2)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)
CL.22
Code List
Pathologic T stage
CL Item
T1 (T1)
CL Item
T2 (T2)
CL Item
T3 (T3)
CL Item
T4 (T4)
Item
Pathologic N Stage
text
CL.23
Code List
Pathologic N Stage
CL Item
No Regional Lymph Node Metastasis (N0)
CL Item
Metastasis In 1 To 3 Regional Lymph Nodes (N1)
CL Item
Metastasis In 4 Or More Regional Lymph Nodes (N2)
CL Item
N3 (N3)
Item
Pathologic M Stage
text
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C13363 (NCI Thesaurus ObjectClass-2)
C0555952 (UMLS 2011AA ObjectClass-2)
C25610 (NCI Thesaurus Property)
C1521733 (UMLS 2011AA Property)
C25727 (NCI Thesaurus Property-2)
C0456533 (UMLS 2011AA Property-2)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)
CL.24
Code List
Pathologic M Stage
CL Item
No Distant Metastasis (M0)
CL Item
Distant Metastasis (M1)
C18206 (NCI Thesaurus)
C1269798 (UMLS 2011AA)
Item Group
Comments
Research Comments
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
InvestigatorSignature
Item
Investigator Signature
text
C25678 (NCI Thesaurus Property)
C1519316 (UMLS 2011AA Property)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)
Investigator Signature Date
Item
Investigator Signature Date
date
C25164 (NCI Thesaurus ValueDomain)
C2346576 (UMLS CUI-1)
C25678 (NCI Thesaurus Property)
C0011008 (UMLS CUI-2)
C25367 (NCI Thesaurus ValueDomain-2)
C17089 (NCI Thesaurus ObjectClass)
Item Group
Ccrr Module For E3201 Surgery Form
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