Instructions: Form is submitted upon completion or termination of RT for all patients assigned RT. Dates are mmdd-yyyy unless specified otherwise. If assigned radiation and none given, complete Q#7, sign date and submit form.

1 forms

StudyEvent: RTOG-0924 T1: Treatment Form
1. Instructions: Form is submitted upon completion or termination of RT for all patients assigned RT. Dates are mmdd-yyyy unless specified otherwise. If assigned radiation and none given, complete Q#7, sign date and submit form.

Name

Type

Description | Question | Decode (Coded Value)

Data type

Alias

Header Module

Item Group

Unnamed Module 1

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

RTOG Patient ID

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)

External Beam RT

Item Group

Module 1

Radiation Therapy Start Date

Item

Radiation Therapy Start Date

date

C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS CUI-1)
C25431 (NCI Thesaurus Property)
C0808070 (UMLS CUI-2)
C25275 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)

Radiation Therapy End Date

Item

Radiation Therapy End Date

date

C25164 (NCI Thesaurus ValueDomain)
C1522449 (UMLS CUI-1)
C15313 (NCI Thesaurus ObjectClass)
C0806020 (UMLS CUI-2)
C25275 (NCI Thesaurus Property)
C25496 (NCI Thesaurus Property-2)

RadiationTherapyTotalDayCount

Item

Total elapsed days (INCLUDING BOTH EXTERNAL RADIATION THERAPY AND BRACHYTHERAPY)

float

C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C25304 (NCI Thesaurus Property)
C0439810 (UMLS 2011AA Property)
C25301 (NCI Thesaurus Property-2)
C0439228 (UMLS 2011AA Property-2)
C25301 (NCI Thesaurus ValueDomain)
C0439228 (UMLS 2011AA ValueDomain)
C25463 (NCI Thesaurus ValueDomain-2)
C0750480 (UMLS 2011AA ValueDomain-2)

Total Number of Fractions

Item

RT Total Fraction Count

float

C25304 (NCI Thesaurus Property)
C1522449 (UMLS CUI-1)
C15313 (NCI Thesaurus ObjectClass)
C1264633 (UMLS CUI-2)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS CUI-3)
C25514 (NCI Thesaurus Property-2)

Radiation Therapy Total Dose

Item

RT Total Dose (TO PTV)

float

C25304 (NCI Thesaurus ValueDomain)
C2169193 (UMLS CUI-1)
C15313 (NCI Thesaurus ObjectClass)
C25488 (NCI Thesaurus ValueDomain-2)
C25382 (NCI Thesaurus Property)

Unscheduled Interruptions in Radiation Therapy

Item

Were there any unscheduled interruptions in radiation therapy? (EXCLUDING HOLIDAYS)

text

C25180 (NCI Thesaurus ValueDomain)
C1522449 (UMLS CUI-1)
C15313 (NCI Thesaurus ObjectClass)
C1512900 (UMLS CUI-2)
C25542 (NCI Thesaurus Property)

CL.2

Code List

Were there any unscheduled interruptions in radiation therapy? (EXCLUDING HOLIDAYS)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes, Due To Toxicity (Yes, due to toxicity)

CL Item

Yes, Due To Other Reason (Yes, due to other reason)

RadiationTherapyUnscheduledInterruptionSpecify

Item

Specify RT interruption reason

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C25594 (NCI Thesaurus Property)
C1518422 (UMLS 2011AA Property)
C25211 (NCI Thesaurus Property-2)
C0086960 (UMLS 2011AA Property-2)
C25542 (NCI Thesaurus Property-3)
C1512900 (UMLS 2011AA Property-3)

Off Treatment Reason

Item

Reason Treatment Ended

text

C25638 (NCI Thesaurus ValueDomain)
C1518544 (UMLS CUI-1)
C25601 (NCI Thesaurus ObjectClass)
C0566251 (UMLS CUI-2)
C25365 (NCI Thesaurus Property)

CL.3

Code List

Reason Treatment Ended

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 (Adverse Event/Side Effects/Complications)

CL Item

Death On Study (Death on study)

CL Item

Patient Withdrawal Or Refusal After Beginning Protocol Therapy (Patient withdrawal/refusal after beginning protocol therapy)

CL Item

Patient Withdrawal Or Refusal Before Beginning Protocol Therapy (Patient withdrawal/refusal prior to beginning protocol therapy)

CL Item

Alternative Therapy (Alternative therapy)

CL Item

Patient Off-treatment For Other Complicating Disease (Patient off-treatment for other complicating disease)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

Off-treatmentAlternativeReasonSpecify

Item

Alternative Therapy, specify

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25601 (NCI Thesaurus ObjectClass)
C1518544 (UMLS 2011AA ObjectClass)
C25415 (NCI Thesaurus Property)
C1523987 (UMLS 2011AA Property)
C25365 (NCI Thesaurus Property-2)
C0678257 (UMLS 2011AA Property-2)

Off Treatment Reason, specify

Item

Other specify

text

C25685 (NCI Thesaurus ValueDomain)
C1518544 (UMLS CUI-1)
C25601 (NCI Thesaurus ObjectClass)
C0566251 (UMLS CUI-2)
C25365 (NCI Thesaurus Property)
C1521902 (UMLS CUI-3)

Radiation Therapy Type

Item

Type of Radiation Therapy Administered

text

C25284 (NCI Thesaurus ValueDomain)
C1522449 (UMLS CUI-1)
C15313 (NCI Thesaurus ObjectClass)
C0683312 (UMLS CUI-2)
C25382 (NCI Thesaurus Property)

CL.4

Code List

Type of Radiation Therapy Administered

CL Item

3d Conformal + Imrt Boost (3D Conformal + IMRT Boost)

CL Item

Imrt (IMRT)

CL Item

Low-dose Treatment Brachytherapy 3-dimensional Conformal Radiation Therapy (3DCRT + Brachytherapy LDR)

C16035 (NCI Thesaurus)
C0600521 (UMLS 2011AA)
C15195 (NCI Thesaurus-3)
C0006098 (UMLS 2011AA-4)
C49341 (NCI Thesaurus-5)
C1708745 (UMLS 2011AA-6)

CL Item

Low-dose Treatment Brachytherapy Imrt (IMRT + Brachytherapy LDR)

C15195 (NCI Thesaurus)
C0006098 (UMLS 2011AA)
C16135 (NCI Thesaurus-3)
C1512814 (UMLS 2011AA-4)
C49341 (NCI Thesaurus-5)
C1708745 (UMLS 2011AA-6)

CL Item

High-dose Rate Brachytherapy 3-dimensional Conformal Radiation Therapy (3DCRT + Brachytherapy HDR)

C16035 (NCI Thesaurus)
C0600521 (UMLS 2011AA)
C15651 (NCI Thesaurus-3)
C0454270 (UMLS 2011AA-4)

CL Item

High-dose Rate Brachytherapy Imrt (IMRT + Brachytherapy HDR)

C16135 (NCI Thesaurus)
C1512814 (UMLS 2011AA)
C15651 (NCI Thesaurus-3)
C0454270 (UMLS 2011AA-4)

DailyLocalizationProstateMethodType

Item

What method of daily prostate localization was used

text

C12410 (NCI Thesaurus ObjectClass)
C0033572 (UMLS 2011AA ObjectClass)
CL052062 (NCI Metathesaurus ObjectClass)
C28264 (NCI Thesaurus ObjectClass-2)
C0475264 (UMLS 2011AA ObjectClass-2)
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)

CL.5

Code List

What method of daily prostate localization was used

CL Item

Cbct (CBCT)

CL Item

Helical Ct (Helical CT)

CL Item

Ct On Rails (CT on Rails)

CL Item

Portal Image/epid (Portal Image/EPID)

CL Item

Ultra Sound (Ultra sound)

CL Item

Optical Tracking (Optical Tracking)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

CL Item

No Daily Localization Used (No Daily Localization Used)

DailyLocalizationProstateMethodSpecify

Item

Other, specify

text

C12410 (NCI Thesaurus ObjectClass)
C0033572 (UMLS 2011AA ObjectClass)
CL052062 (NCI Metathesaurus ObjectClass)
C28264 (NCI Thesaurus ObjectClass-2)
C0475264 (UMLS 2011AA ObjectClass-2)
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)

Brachytherapy

Item Group

Brachytherapy

BrachytherapyOff-TreatmentReason

Item

IF BRACHYTHERAPY NOT UTILIZED, PROVIDE REASON

text

C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
C25601 (NCI Thesaurus Property)
C1518544 (UMLS 2011AA Property)
C15195 (NCI Thesaurus ObjectClass)
C0006098 (UMLS 2011AA ObjectClass)

CL.6

Code List

IF BRACHYTHERAPY NOT UTILIZED, PROVIDE REASON

CL Item

Na Dose Administered Within Protocol Specifications (NA Dose administered within protocol specifications)

CL Item

Not Technically Feasible (Not technically feasible)

CL Item

Patient Refused (Patient refused)

CL Item

Inadequate To Treat Extent Of Disease (Inadequate to treat extent of disease)

CL Item

Md Preference (MD preference)

CL Item

Progression Or Relapse (Progression or relapse)

CL Item

Toxicity Or Treatment Reaction (Toxicity or treatment reaction)

CL Item

Death (Death)

C28554 (NCI Thesaurus)
C0011065 (UMLS 2011AA)

CL Item

Alternative Therapy Given (Alternative therapy given)

CL Item

Other Reason, Specify (Other reason, specify)

Alternative therapy, specify

Item

Specify therapy

text

C25685 (NCI Thesaurus ValueDomain)
C0949216 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass)
C25415 (NCI Thesaurus ObjectClass-2)
C25382 (NCI Thesaurus Property)

BrachytherapyOffTreatmentReasonSpecify

Item

Other reason, specify

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25601 (NCI Thesaurus Property)
C1518544 (UMLS 2011AA Property)
C15195 (NCI Thesaurus ObjectClass)
C0006098 (UMLS 2011AA ObjectClass)

Low-Dose Radiation (LDR)

Item Group

Low-dose Radiation

BrachytherapyImplantDate

Item

Date of implant

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15195 (NCI Thesaurus ObjectClass)
C0006098 (UMLS 2011AA ObjectClass)
C17948 (NCI Thesaurus Property)
C0013183 (UMLS 2011AA Property)

CTPostBrachytherapyDate

Item

Date of post-implant CT

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C17204 (NCI Thesaurus ObjectClass)
C0040405 (UMLS 2011AA ObjectClass)
C38008 (NCI Thesaurus Property)
C0687676 (UMLS 2011AA Property)
CL054378 (NCI Metathesaurus Property)

BrachytherapyRadioactiveSeedImplantDosingUnitLostInd-3

Item

Seed loss (were seeds expelled within the 3 weeks of implant? If yes, report details in Comment section.)

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25560 (NCI Thesaurus Property)
C0745777 (UMLS 2011AA Property)
C67446 (NCI Thesaurus Property-2)
C1882540 (UMLS 2011AA Property-2)
C15195 (NCI Thesaurus ObjectClass)
C0006098 (UMLS 2011AA ObjectClass)

CL.7

Code List

Seed loss (were seeds expelled within the 3 weeks of implant? If yes, report details in Comment section.)

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)

SurgicalProcedureCatheterUrethraPostBrachytherapyPerformedTherapyInd-3

Item

Was an indwelling urinary catheter inserted since implant

text

C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C38008 (NCI Thesaurus Property-2)
C0687676 (UMLS 2011AA Property-2)
C15195 (NCI Thesaurus Property-3)
C0006098 (UMLS 2011AA Property-3)
C17446 (NCI Thesaurus Property-4)
C0085590 (UMLS 2011AA Property-4)
C12417 (NCI Thesaurus Property-5)
C0041967 (UMLS 2011AA Property-5)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)

CL.8

Code List

Was an indwelling urinary catheter inserted since implant

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)

SurgicalProcedureCatheterUrethraPostBrachytherapyPerformedDate

Item

Date inserted (Provide estimate if exact date unknown)

date

C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C38008 (NCI Thesaurus Property-2)
C0687676 (UMLS 2011AA Property-2)
C15195 (NCI Thesaurus Property-3)
C0006098 (UMLS 2011AA Property-3)
C17446 (NCI Thesaurus Property-4)
C0085590 (UMLS 2011AA Property-4)
C12417 (NCI Thesaurus Property-5)
C0041967 (UMLS 2011AA Property-5)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)

SurgicalProcedureCatheterUrethraPostBrachytherapyRemovePerformedDate

Item

Date removed (Provide estimate if exact date unknown)

date

C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C38008 (NCI Thesaurus Property-2)
C0687676 (UMLS 2011AA Property-2)
C15195 (NCI Thesaurus Property-3)
C0006098 (UMLS 2011AA Property-3)
C17446 (NCI Thesaurus Property-4)
C0085590 (UMLS 2011AA Property-4)
C64914 (NCI Thesaurus Property-5)
C1883720 (UMLS 2011AA Property-5)
C12417 (NCI Thesaurus Property-6)
C0041967 (UMLS 2011AA Property-6)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)

High-Dose Radiation (HDR)

Item Group

High-dose Radiation

BrachytherapyFirstFractionationImplantationDate

Item

Date of implant fraction #1

date

C15195 (NCI Thesaurus ObjectClass)
C0006098 (UMLS 2011AA ObjectClass)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C15654 (NCI Thesaurus Property-2)
C0016640 (UMLS 2011AA Property-2)
C51982 (NCI Thesaurus Property-3)
C0021107 (UMLS 2011AA Property-3)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)

BrachytherapyFirstFractionationImplantationTime

Item

Time of implant fraction #1

time

C15195 (NCI Thesaurus ObjectClass)
C0006098 (UMLS 2011AA ObjectClass)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C15654 (NCI Thesaurus Property-2)
C0016640 (UMLS 2011AA Property-2)
C51982 (NCI Thesaurus Property-3)
C0021107 (UMLS 2011AA Property-3)
C25207 (NCI Thesaurus ValueDomain)
C0040223 (UMLS 2011AA ValueDomain)

BrachytherapySecondFractionationImplantationDate

Item

Date of implant fraction #2

date

C15195 (NCI Thesaurus ObjectClass)
C0006098 (UMLS 2011AA ObjectClass)
C25666 (NCI Thesaurus Property)
C0205436 (UMLS 2011AA Property)
C15654 (NCI Thesaurus Property-2)
C0016640 (UMLS 2011AA Property-2)
C51982 (NCI Thesaurus Property-3)
C0021107 (UMLS 2011AA Property-3)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)

RadiationTherapyTotalDayCount

Item

Total elapsed days (INCLUDING BOTH EXTERNAL RADIATION THERAPY AND BRACHYTHERAPY)

float

BrachytherapySecondFractionationImplantationTime

Item

Time of implant fraction #2

time

C15195 (NCI Thesaurus ObjectClass)
C0006098 (UMLS 2011AA ObjectClass)
C25666 (NCI Thesaurus Property)
C0205436 (UMLS 2011AA Property)
C15654 (NCI Thesaurus Property-2)
C0016640 (UMLS 2011AA Property-2)
C51982 (NCI Thesaurus Property-3)
C0021107 (UMLS 2011AA Property-3)
C25207 (NCI Thesaurus ValueDomain)
C0040223 (UMLS 2011AA ValueDomain)

BrachytherapyCatheterImplantationUseCount

Item

Number of implant catheters used

float

C15195 (NCI Thesaurus ObjectClass)
C0006098 (UMLS 2011AA ObjectClass)
C17446 (NCI Thesaurus Property)
C0085590 (UMLS 2011AA Property)
C25340 (NCI Thesaurus Property-2)
C0457083 (UMLS 2011AA Property-2)
C51982 (NCI Thesaurus Property-3)
C0021107 (UMLS 2011AA Property-3)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)

Comments

Item Group

Footer

Research Comments

Item

Comments

text

C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)

Responsible Person Signature

Item

Signature of Person Completing This Form

text

C25704 (NCI Thesaurus ValueDomain)
C1550483 (UMLS CUI-1)
C25190 (NCI Thesaurus ObjectClass)
C25657 (NCI Thesaurus ObjectClass-2)
C25678 (NCI Thesaurus Property)

Form Completion Date

Item

Date Form Originally Completed

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)

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