ID

10900

Description

RTOG-0421 TF: Radiation Therapy Oncology Group Phase III Recurrent Head and Neck Study Treatment Summary Form NCT00113399 Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With Recurrent Head and Neck Cancer That Cannot Be Removed By Surgery Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=EC64FA04-6994-6A06-E034-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=EC64FA04-6994-6A06-E034-0003BA3F9857

Keywords

Versions (3)
  1. 9/19/12 9/19/12 -
  2. 1/9/15 1/9/15 - Martin Dugas
  3. 6/12/15 6/12/15 -
Uploaded on

June 12, 2015

DOI

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Creative Commons BY-NC 3.0 Legacy
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RTOG-0421 TF: Radiation Therapy Oncology Group Phase III Recurrent Head and Neck Study Treatment Summary Form NCT00113399

English

No Instruction available.

1 forms  
  1. StudyEvent: RTOG-0421 TF: Radiation Therapy Oncology Group Phase III Recurrent Head and Neck Study Treatment Summary Form
    1. No Instruction available.
RTOG clinical trial administrative data
Description

RTOG clinical trial administrative data

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 Name
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
Patient Study No.
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
Assessment of chemotherapy
Description

Assessment of chemotherapy

PATIENT HEIGHT
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
PATIENT WEIGHT
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
BODY SURFACE AREA
Description

Body Surface Area

Data type

float

Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0005902
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25157
CURRENT CYCLE NUMBER
Description

Cycle Number Chemotherapeutics

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2045829
NCI Thesaurus Property
C25471
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property-2
C25379
Assigned Treatment Arm
Description

HeadandNeckTreatmentAssignmentType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C12418
UMLS 2011AA ObjectClass
C0460004
NCI Thesaurus ObjectClass-2
C15368
NCI Thesaurus Property
C25426
UMLS 2011AA Property
C1516050
WAS CARBOPLATIN SUBSTITUTED FOR CISPLATIN FOR THIS CYCLE?
Description

HeadandNeckChemotherapyChangeInd

Data type

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ObjectClass
C15632
UMLS 2011AA ObjectClass
C0392920
NCI Thesaurus ObjectClass-2
C12418
UMLS 2011AA ObjectClass-2
C0460004
NCI Thesaurus Property
C25446
UMLS 2011AA Property
C0392747
CURRENT OBJECTIVE RESPONSE (see protocol section 11.4)
Description

HeadandNeckTreatmentCurrentResponseType

Data type

text

Alias
NCI Thesaurus ObjectClass
C12418
UMLS 2011AA ObjectClass
C0460004
NCI Thesaurus ObjectClass-2
C15368
NCI Thesaurus Property
C25755
UMLS 2011AA Property
C0871261
NCI Thesaurus Property-2
C25471
UMLS 2011AA Property-2
C0521116
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
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
CYCLE START DATE
Description

Chemotherapy Cycle Start Date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1302181
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ValueDomain-2
C25431
UMLS CUI-2
C3173309
NCI Thesaurus Property
C25379
CYCLE END DATE
Description

Chemotherapy Cycle End Date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1302181
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25379
UMLS CUI-2
C0806020
TOTAL DOSE OF AGENT FOR THIS CYCLE
Description

Agent Total Dose

Data type

float

Alias
NCI Thesaurus ValueDomain
C25304
UMLS CUI-1
C2986497
NCI Thesaurus Property
C25379
NCI Thesaurus ValueDomain-2
C25488
NCI Thesaurus ObjectClass
C1708
REASON FOR DOSE MODIFICATION (Use code table below)
Description

TreatmentReducedDoseReason

Data type

text

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25256
UMLS 2011AA Property
C1265611
REASON TREATMENT ENDED (Use code table below)
Description

TreatmentDiscontinuedType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25484
UMLS 2011AA Property
C1444662
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
Name of person completing this form
Description

Person Completing Form

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C1550483
NCI Thesaurus ObjectClass
C25657
NCI Thesaurus Property
C25364
Form completion date, original
Description

Form Completion Date

Data type

date

Alias
NCI Thesaurus ObjectClass
C19464
UMLS CUI-1
C1549507
NCI Thesaurus Property
C25250
NCI Thesaurus Property-2
C25604
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25367
Comments
Description

Comments

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No Instruction available.

1 forms
  1. StudyEvent: RTOG-0421 TF: Radiation Therapy Oncology Group Phase III Recurrent Head and Neck Study Treatment Summary Form
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
RTOG clinical trial administrative data
Protocol ID RTOG
Item
RTOG Study No.
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1514695 (UMLS CUI-2)
C19778 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
RadiationTherapyOncologyGroupPatientCaseIdentifierNumber
Item
Case #
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C19778 (NCI Thesaurus ObjectClass-2)
C1514695 (UMLS 2011AA ObjectClass-2)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C49152 (NCI Thesaurus Property-2)
C1706256 (UMLS 2011AA Property-2)
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
Institution Name
Item
Institution Name
text
C25191 (NCI Thesaurus ValueDomain)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass)
C21541 (NCI Thesaurus ValueDomain-2)
C25364 (NCI Thesaurus Property)
Institution Number
Item
Institution No.
text
C25337 (NCI Thesaurus ValueDomain)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass)
C0805701 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
Patient Initials
Item
Patient Initials
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Trial subject ID RTOG
Item
Patient Study No.
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1514695 (UMLS CUI-2)
C19778 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Data amended
Item
AMENDED DATA
boolean
C38148 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)
Item Group
Assessment of chemotherapy
Patient Height
Item
PATIENT HEIGHT
float
C25209 (NCI Thesaurus ValueDomain)
C0489786 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25347 (NCI Thesaurus Property)
Patient Weight
Item
PATIENT WEIGHT
float
C25209 (NCI Thesaurus ValueDomain)
C0005910 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25208 (NCI Thesaurus Property)
Body Surface Area
Item
BODY SURFACE AREA
float
C25209 (NCI Thesaurus ValueDomain)
C0005902 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25157 (NCI Thesaurus Property)
Cycle Number Chemotherapeutics
Item
CURRENT CYCLE NUMBER
text
C25337 (NCI Thesaurus ValueDomain)
C2045829 (UMLS CUI-1)
C25471 (NCI Thesaurus Property)
C15368 (NCI Thesaurus ObjectClass)
C25379 (NCI Thesaurus Property-2)
Item
Assigned Treatment Arm
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C12418 (NCI Thesaurus ObjectClass)
C0460004 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass-2)
C25426 (NCI Thesaurus Property)
C1516050 (UMLS 2011AA Property)
CL.2
Code List
Assigned Treatment Arm
CL Item
Arm 1, Rt Plus Cisplatin / Paclitaxel (Arm 1, RT plus Cisplatin / Paclitaxel)
CL Item
Arm 2, Cisplatin / 5-fu (Arm 2, Cisplatin / 5-FU)
CL Item
Arm 2, Cisplatin / Paclitaxel (Arm 2, Cisplatin / Paclitaxel)
CL Item
Arm 2, Cisplatin / Docetaxel (Arm 2, Cisplatin / Docetaxel)
Item
WAS CARBOPLATIN SUBSTITUTED FOR CISPLATIN FOR THIS CYCLE?
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C12418 (NCI Thesaurus ObjectClass-2)
C0460004 (UMLS 2011AA ObjectClass-2)
C25446 (NCI Thesaurus Property)
C0392747 (UMLS 2011AA Property)
CL.3
Code List
WAS CARBOPLATIN SUBSTITUTED FOR CISPLATIN FOR THIS CYCLE?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes, For Toxicity (Yes, for toxicity)
CL Item
Yes, For Other Reason (Yes, for other reason)
Item
CURRENT OBJECTIVE RESPONSE (see protocol section 11.4)
text
C12418 (NCI Thesaurus ObjectClass)
C0460004 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass-2)
C25755 (NCI Thesaurus Property)
C0871261 (UMLS 2011AA Property)
C25471 (NCI Thesaurus Property-2)
C0521116 (UMLS 2011AA Property-2)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.4
Code List
CURRENT OBJECTIVE RESPONSE (see protocol section 11.4)
CL Item
Not Assessed (Not assessed)
CL Item
Complete Response (Complete response)
CL Item
Partial Response (Partial response)
CL Item
Stable Disease (Stable disease)
C18213 (NCI Thesaurus)
C0677946 (UMLS 2011AA)
CL Item
Progressive Disease (Progressive disease)
C35571 (NCI Thesaurus)
C1335499 (UMLS 2011AA)
CL Item
Symptomatic Deterioration (Symptomatic deterioration)
Agent
Item
AGENT NAME
text
C25364 (NCI Thesaurus Property)
C1521826 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C1708 (NCI Thesaurus ValueDomain)
C42614 (NCI Thesaurus ValueDomain-2)
Chemotherapy Cycle Start Date
Item
CYCLE START DATE
date
C25164 (NCI Thesaurus ValueDomain)
C1302181 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass)
C25431 (NCI Thesaurus ValueDomain-2)
C3173309 (UMLS CUI-2)
C25379 (NCI Thesaurus Property)
Chemotherapy Cycle End Date
Item
CYCLE END DATE
date
C25164 (NCI Thesaurus ValueDomain)
C1302181 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass)
C25379 (NCI Thesaurus Property)
C0806020 (UMLS CUI-2)
Agent Total Dose
Item
TOTAL DOSE OF AGENT FOR THIS CYCLE
float
C25304 (NCI Thesaurus ValueDomain)
C2986497 (UMLS CUI-1)
C25379 (NCI Thesaurus Property)
C25488 (NCI Thesaurus ValueDomain-2)
C1708 (NCI Thesaurus ObjectClass)
Item
REASON FOR DOSE MODIFICATION (Use code table below)
text
C15368 (NCI Thesaurus ObjectClass)
C25256 (NCI Thesaurus Property)
C1265611 (UMLS 2011AA Property)
CL.5
Code List
REASON FOR DOSE MODIFICATION (Use code table below)
CL Item
None (None)
C41132 (NCI Thesaurus)
C0549184 (UMLS 2011AA)
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
Adverse Event/side Effects/complications (Toxicity/side effects/complications)
CL Item
Death On Study (Death on study)
CL Item
Patient Withdrawal Or Refusal After Beginning Protocol Therapy (Patient withdrawal or refusal after beginning protocol therapy)
CL Item
Patient Withdrawal Or Refusal Prior To Beginning Protocol Therapy (Patient withdrawal or refusal prior to beginning protocol therapy)
CL Item
Alternative Therapy (Alternative therapy)
CL Item
Other Complicating Disease (Other complicating disease)
CL Item
Complete Response To Protocol Therapy (Complete response to protocol therapy)
CL Item
Stable Disease (Stable disease)
C18213 (NCI Thesaurus)
C0677946 (UMLS 2011AA)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
C17649 (NCI Thesaurus-3)
C0205394 (UMLS 2011AA-4)
Item
REASON TREATMENT ENDED (Use code table below)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25484 (NCI Thesaurus Property)
C1444662 (UMLS 2011AA Property)
CL.6
Code List
REASON TREATMENT ENDED (Use code table below)
CL Item
None (None)
C41132 (NCI Thesaurus)
C0549184 (UMLS 2011AA)
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 On Study (Death on study)
CL Item
Patient Withdrawal Or Refusal (Patient withdrawal or refusal after beginning protocol therapy)
CL Item
Patient Withdrawal Or Refusal Prior To Beginning Protocol Therapy (Patient withdrawal or refusal prior to beginning protocol therapy)
CL Item
Alternative Therapy (Alternative therapy)
CL Item
Other Complicating Disease (Other complicating disease)
CL Item
Complete Response To Protocol Therapy (Complete response to protocol therapy)
CL Item
Stable Disease (Stable disease)
C18213 (NCI Thesaurus)
C0677946 (UMLS 2011AA)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (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)
Person Completing Form
Item
Name of person completing this form
text
C25191 (NCI Thesaurus ValueDomain)
C1550483 (UMLS CUI-1)
C25657 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
Form Completion Date
Item
Form completion date, original
date
C19464 (NCI Thesaurus ObjectClass)
C1549507 (UMLS CUI-1)
C25250 (NCI Thesaurus Property)
C25604 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
Item Group
Comments
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