ID

7642

Beschreibung

ACNS0122 Consolidation Worksheet Neoadjuvant Chemotherapy With or Without Second-Look Surgery Followed by Radiation Therapy With or Without Peripheral Stem Cell Transplantation in Treating Patients With Intracranial Germ Cell Tumors Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=BD4225D7-47E1-0D12-E034-0003BA12F5E7

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=BD4225D7-47E1-0D12-E034-0003BA12F5E7

Stichworte

Hirntumoren

Zentralnervensystemtumoren

Hochgeladen am

9. Januar 2015

DOI

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Lizenz

Creative Commons BY-NC 3.0 Legacy

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Brain and Central Nervous System Tumors NCT00047320 Treatment - ACNS0122 Consolidation Worksheet - 2168511v3.0

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StudyEvent: ACNS0122 Consolidation Worksheet
1. No Instruction available.

Name

Typ

Description | Question | Decode (Coded Value)

Datentyp

Alias

Unnamed2

Item Group

Unnamed2

TreatmentReportingPeriodNumber

Item

Reporting Period

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C15368 (NCI Thesaurus ObjectClass)
C25651 (NCI Thesaurus Property-2)
C0700287 (UMLS 2011AA Property-2)

Reporting Period Start Date

Item

Reporting Period start date

date

C15368 (NCI Thesaurus ObjectClass)
C25616 (NCI Thesaurus Property)
C2361257 (UMLS CUI-1)
C25651 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)

Reporting Period End Date

Item

Reporting Period end date

date

C25164 (NCI Thesaurus ValueDomain)
C2361259 (UMLS CUI-1)
C25616 (NCI Thesaurus Property)
C15368 (NCI Thesaurus ObjectClass)
C25651 (NCI Thesaurus Property-2)

Patient Height

Item

Height

float

C25209 (NCI Thesaurus ValueDomain)
C0489786 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25347 (NCI Thesaurus Property)

Patient Weight

Item

Weight

float

C25209 (NCI Thesaurus ValueDomain)
C0005910 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25208 (NCI Thesaurus Property)

Body Surface Area

Item

BSA

float

C25209 (NCI Thesaurus ValueDomain)
C0005902 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25157 (NCI Thesaurus Property)

TUMOR EVALUATION

Item Group

Tumor Evaluation

Evaluation method

Item

Type [imaging studies]

text

C25284 (NCI Thesaurus ValueDomain)
C2911685 (UMLS CUI-1)
C20989 (NCI Thesaurus ObjectClass)
C16847 (NCI Thesaurus Property)

CL.1

Code List

Type [imaging studies]

CL Item

Mri (Cranial MRI with gadolinium)

CL Item

Mri (MRI of Spine with gadolinium)

CL Item

Other, Specify (Other (specify))

Evaluation method, specify

Item

Specify [other type of imaging study]

text

C25685 (NCI Thesaurus ValueDomain)
C2911685 (UMLS CUI-1)
C20989 (NCI Thesaurus ObjectClass)
C1521902 (UMLS CUI-2)
C16847 (NCI Thesaurus Property)

LesionAssessmentDate

Item

Date

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)

DISEASE STATUS

Item Group

Disease Status

DiseaseExaminedDiseaseResponseInd-2

Item

Was the patient's disease status evaluated during this reporting interval?

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25500 (NCI Thesaurus Property)
C0332128 (UMLS 2011AA Property)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)

TumorResponseType

Item

Type of response

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25755 (NCI Thesaurus Property)
C0871261 (UMLS 2011AA Property)

CL.3

Code List

Type of response

CL Item

Complete Response (Complete Response (CR))

CL Item

Partial Response (Partial Response (PR))

C18212 (NCI Thesaurus)

CL Item

Less than Partial Response (<PR) (Less than Partial Response (<PR))

CL Item

Progressive Disease (Progressive Disease (PD))

C35571 (NCI Thesaurus)
C1335499 (UMLS 2011AA)

CL Item

Recurrent Disease (Recurrent Disease)

CL Item

Stable Disease (Stable Disease)

C18213 (NCI Thesaurus)
C0677946 (UMLS 2011AA)

CL Item

Insufficient Evaluation (Not evaluable)

CL Item

Death Prior To Completion Of Protocol Criteria (Early death)

CL Item

Incomplete Response Or Stable Disesase (Incomplete response/SD)

ResponseConfirmedDate

Item

Date

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25755 (NCI Thesaurus ObjectClass)
C0871261 (UMLS 2011AA ObjectClass)
C25458 (NCI Thesaurus Property)
C0750484 (UMLS 2011AA Property)

Research Comments

Item

Comments

text

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

EVALUATIONS

Item Group

Evaluations

NeurologicalAssessmentPerformedInd-3

Item

Was a Neurologic assessment done?

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C25262 (NCI Thesaurus ObjectClass-2)
C0205494 (UMLS 2011AA ObjectClass-2)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)

CL.4

Code List

Was a Neurologic assessment done?

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

Not done/not available (Not done/not available)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

EndocrineAssessmentPerformedInd-3

Item

Was endocrinologic evaluation done?

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)

CL.5

Code List

Was endocrinologic evaluation done?

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

Not done/not available (Not done/not available)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

SIGNIFICANT EVENTS DURING THIS REPORTING PERIOD

Item Group

Significant Events During This Reporting Period

Dose Modification

Item

Were there any dose modifications or additions/omissions to protocol treatment?

text

C25180 (NCI Thesaurus ValueDomain)
C1707811 (UMLS CUI-1)
C25256 (NCI Thesaurus ObjectClass)
C25572 (NCI Thesaurus Property)
C25572 (NCI Thesaurus ValueDomain-2)

CL.6

Code List

Were there any dose modifications or additions/omissions to protocol treatment?

CL Item

Yes (Yes)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes, Planned (i.e., The Treatment Was Changed According To Protocol Guidelines) (Yes, planned)

CL Item

Yes, Unplanned (i.e., The Treatment Change Was Not Part Of Protocol Guidelines) (Yes, unplanned)

DoseModificationText

Item

specify [other reason for dose modifications] (If due to other reason,)

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25256 (NCI Thesaurus ObjectClass)
C1265611 (UMLS 2011AA ObjectClass)
C25572 (NCI Thesaurus Property)

DoseModificationText

Item

specify [other reason for dose modifications] (If due to other reason,)

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25256 (NCI Thesaurus ObjectClass)
C1265611 (UMLS 2011AA ObjectClass)
C25572 (NCI Thesaurus Property)

DoseModificationText

Item

specify [other reason for dose modifications] (If due to other reason,)

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25256 (NCI Thesaurus ObjectClass)
C1265611 (UMLS 2011AA ObjectClass)
C25572 (NCI Thesaurus Property)

NewCancerDiagnosisInd-3

Item

Has a new primary cancer or MDS been diagnosed that has not been previously reported?

boolean

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25586 (NCI Thesaurus ObjectClass)
C0205314 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus ObjectClass-2)
C0006826 (UMLS 2011AA ObjectClass-2)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)

NewCancerDiagnosisDate

Item

Date of diagnosis

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)

PatientOff-treatmentInd-3

Item

Is patient off protocol therapy?

boolean

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25601 (NCI Thesaurus Property)
C1518544 (UMLS 2011AA Property)

Treatment End Date

Item

date off [protocol therapy] (If yes,)

date

C25164 (NCI Thesaurus ValueDomain)
C1531784 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass)
C25275 (NCI Thesaurus Property)

Off Treatment Reason

Item

Reason treatment ended

text

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

CL.11

Code List

Reason treatment ended

CL Item

Disease Progression, Relapse During Active Treatment (Neuraxis dissemination during or after chemotherapy)

CL Item

Disease Progression, Relapse During Active Treatment (Neuraxis dissemination or locally progressive diseases during or after radiation therapy.)

CL Item

Patient withdrawn from protocol therapy due to physician?s choice. (Patient withdrawn from protocol therapy due to physician?s choice.)

CL Item

Decision of the patient?s family to withdraw the patient from protocol therapy. (Decision of the patient?s family to withdraw the patient from protocol therapy.)

CL Item

Patient refusal or withdrawal from therapy. (Patient refusal or withdrawal from therapy.)

CL Item

Treatment Completed Per Protocol Criteria (Completion of protocol therapy.)

CL Item

Alternative Therapy (Alternative therapy)

CL Item

Lost To Follow-up (Lost to follow-up)

CL310949 (NCI Metathesaurus)

CL Item

Death On Study (Death on study)

CL Item

Cytogenetic Resistance (Cytogenetic Resistance)

CL Item

Disease Progression Before Active Treatment (Disease Progression before Active Treatment)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

CL Item

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

CL Item

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

CL Item

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

CL Item

Adverse Event/side Effects/complications (Adverse Event/Side Effects/Complications)

PatientVitalStatus

Item

Life status at the end of this reporting period

text

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C18003 (NCI Thesaurus ValueDomain)
C0442732 (UMLS 2011AA ValueDomain)
C25688 (NCI Thesaurus ValueDomain-2)
C0449438 (UMLS 2011AA ValueDomain-2)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)

CL.12

Code List

Life status at the end of this reporting period

CL Item

Alive (Alive)

CL Item

Dead (Dead)

PatientLostFollow-upInd-2

Item

Was patient unable to be contacted for current scheduled follow-up?

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25560 (NCI Thesaurus Property)
C0745777 (UMLS 2011AA Property)
C16033 (NCI Thesaurus Property-2)
C1522577 (UMLS 2011AA Property-2)

PatientOtherEnrollmentInd-2

Item

Was the patient enrolled on another COG therapeutic study at the end of the reporting period?

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)

PatientWithdrawFollow-upConsentInd-2

Item

Did the patient withdraw consent for follow-up at the end of the reporting period?

boolean

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C16033 (NCI Thesaurus Property)
C1522577 (UMLS 2011AA Property)
C25460 (NCI Thesaurus Property-2)
C1511481 (UMLS 2011AA Property-2)
C38061 (NCI Thesaurus Property-3)
C2349954 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

Non-protocolTherapyAdministeredInd-3

Item

Did the patient receive non-protocol anti-cancer treatment during this reporting period?

boolean

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25590 (NCI Thesaurus ObjectClass-2)
C1518384 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)

Non-protocolTherapyAdministeredType

Item

Type [non-protocol treatment] (Types of Treatment)

text

C15368 (NCI Thesaurus ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)

CL.17

Code List

Type [non-protocol treatment] (Types of Treatment)

CL Item

Chemotherapy (Chemotherapy)

C15632 (NCI Thesaurus)
C0392920 (UMLS 2011AA)

CL Item

Surgery (Surgery)

C17173 (NCI Thesaurus)
C0038894 (UMLS 2011AA)

CL Item

External Beam Radiation (Radiation)

CL Item

Bone Marrow Transplant (Bone Marrow Transplant)

CL Item

Other Therapy (Other (specify))

C15645 (NCI Thesaurus)
C0418967 (UMLS 2011AA)

CL Item

Extensive Radiation (Extensive radiation)

C16230 (NCI Thesaurus)
C1517030 (UMLS 2011AA)

CL Item

Limited Radiation (Limited radiation)

CL Item

Radiation (nos) (Radiation (NOS))

Non-protocolTherapyOtherAdministeredName

Item

Specify [other type of non-protocol treatment]

text

C15368 (NCI Thesaurus ObjectClass)
C25590 (NCI Thesaurus ObjectClass-2)
C1518384 (UMLS 2011AA ObjectClass)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
C42614 (NCI Thesaurus ValueDomain)
C0027365 (UMLS 2011AA ValueDomain)

Non-protocolTherapyBeginDate

Item

Start Date [non-protocol treatment]

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25431 (NCI Thesaurus ValueDomain-2)
C0439659 (UMLS 2011AA ValueDomain-2)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)

Non-protocolTherapyEndDate

Item

End Date [non-protocol treatment]

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)

Non-protocolTherapyAdministeredText

Item

Description (drug, dose, etc.)

text

C15368 (NCI Thesaurus ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)

TREATMENT PLAN AFTER THIS TREATMENT PERIOD

Item Group

Treatment Plan After This Treatment Period

TreatmentPostPlannedType

Item

What is the patient's treatment plan after chemotherapy?

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C38008 (NCI Thesaurus Property)
C0687676 (UMLS 2011AA Property)
C25619 (NCI Thesaurus Property-2)
C1301732 (UMLS 2011AA Property-2)
C0087111 (NCI Metathesaurus ObjectClass)

CL.18

Code List

What is the patient's treatment plan after chemotherapy?

CL Item

Second-look Surgery (Second surgery)

C15317 (NCI Thesaurus)
C0949626 (UMLS 2011AA)

CL Item

Conformal Radiation Therapy (Conformal Radiation Therapy)

CL Item

No Further Therapy (No further therapy)

CL Item

Other Specify (Other, specify)

TreatmentPostPlannedSpecify

Item

please specify [other treatment plan after chemotherapy] (If 'Other',)

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C38008 (NCI Thesaurus Property)
C0687676 (UMLS 2011AA Property)
C25619 (NCI Thesaurus Property-2)
C1301732 (UMLS 2011AA Property-2)
C0087111 (NCI Metathesaurus ObjectClass)

TOXICITIES

Item Group

Toxicities

CTCAdverseEventCategory

Item

ID

Beschreibung

Link

Stichworte

Versionen (5)

Hochgeladen am

DOI

Lizenz

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Itemgroup Kommentare für :

Item Kommentare für :

Brain and Central Nervous System Tumors NCT00047320 Treatment - ACNS0122 Consolidation Worksheet - 2168511v3.0

No Instruction available.

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