ID

1000

Beskrivning

E5103 Radiation Therapy Form Doxorubicin, Cyclophosphamide, and Paclitaxel With or Without Bevacizumab in Treating Patients With Lymph Node-Positive or High-Risk, Lymph Node-Negative Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=22AFD24B-EC68-5512-E044-0003BA3F9857

Länk

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=22AFD24B-EC68-5512-E044-0003BA3F9857

Nyckelord

D001943

Uppladdad den

26 augusti 2012

DOI

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Licens

Creative Commons BY-NC 3.0 Legacy

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Breast Cancer NCT00433511 Treatment - E5103 Radiation Therapy Form - 2543728v1.0

model
Detaljer

Instructions: Complete this form according to the forms submission schedule. Submit original to the ECOG Coordinating Center; keep a copy for your files.

1 Formulär

StudyEvent: E5103 Radiation Therapy Form
1. Instructions: Complete this form according to the forms submission schedule. Submit original to the ECOG Coordinating Center; keep a copy for your files.

Name

Typ

Description | Question | Decode (Coded Value)

Datatyp

Alias

Header1

Item Group

Unnamed1

ProtocolECOGIdentifierNumber

Item

ECOG Protocol Number

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25491 (NCI Thesaurus Property)
C1512162 (UMLS 2011AA Property)

PatientECOGIdentifierNumber

Item

ECOG Patient ID

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25491 (NCI Thesaurus Property)
C1512162 (UMLS 2011AA Property)

CollectedDataFormName

Item

DCI Name

text

C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C19464 (NCI Thesaurus Property)
C0376315 (UMLS 2011AA Property)
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25452 (NCI Thesaurus ObjectClass)

RegistrationStepNumber

Item

Registration Step

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25646 (NCI Thesaurus ObjectClass)
C1514821 (UMLS 2011AA ObjectClass)
C16154 (NCI Thesaurus Property)
C1704379 (UMLS 2011AA Property)
C16154 (NCI Thesaurus ValueDomain)
C1704379 (UMLS 2011AA ValueDomain)

ReportingEvaluationPeriodType

Item

Reporting Period

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25214 (NCI Thesaurus ObjectClass)
C0220825 (UMLS 2011AA ObjectClass)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25651 (NCI Thesaurus ObjectClass)
C0700287 (UMLS 2011AA ObjectClass)

CL.1

Code List

Reporting Period

CL Item

Radiation Therapy (End of radiation therapy)

C15313 (NCI Thesaurus)
C1522449 (UMLS 2011AA)

Header2

Item Group

Unnamed2

PatientInitialsName

Item

Patient Initials (Last,First)

text

C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25536 (NCI Thesaurus Property)
C1555582 (UMLS 2011AA Property)

ProtocolECOGIdentifierNumber

Item

ECOG Protocol Number

text

PatientECOGIdentifierNumber

Item

ECOG Patient ID

text

ProtocolParticipatingIdentifierNumber

Item

Participating Group Protocol Number

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25608 (NCI Thesaurus Property)
C0679823 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)

PatientParticipatingIdentifierNumber

Item

Participating Group Patient ID

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25608 (NCI Thesaurus Property)
C0679823 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)

CombinedInstitutionName

Item

Institution/Affiliate

text

C25454 (NCI Thesaurus ObjectClass)
C0205195 (UMLS 2011AA ObjectClass)
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ValueDomain)
C0018704 (UMLS 2011AA ValueDomain)

Unnamed1

Item Group

Unnamed1

ProtocolRTAdministeredInd-3

Item

Did the patient have protocol-defined radiation therapy as part of protocol treatment?

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C42651 (NCI Thesaurus ObjectClass)
C0442711 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)

CL.2

Code List

Did the patient have protocol-defined radiation therapy as part of protocol treatment?

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

RadiationTherapyNotAdministeredReason

Item

Radiation therapy not administered reason (if applicable - Note: Information regarding patients that are receiving Radiation Therapy per protocol/physician discretion must be collected on - this form.)

text

C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
CL052458 (NCI Metathesaurus Property)

CL.3

Code List

CL Item

Mastectomy (Mastectomy)

CL Item

Local, Regional Or Distant Recurrence Prior To Rt (Local, Regional or Distant recurrence prior to RT)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

RadiationTherapyNotAdministeredSpecify

Item

Other, specify

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
CL052458 (NCI Metathesaurus Property)

ProtocolRadiationTherapyAdministeredInterval

Item

When did the patient start receiving radiation therapy as part of protocol treatment?

text

C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C42651 (NCI Thesaurus ObjectClass)
C0442711 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25543 (NCI Thesaurus ValueDomain)
C1272706 (UMLS 2011AA ValueDomain)

CL.4

Code List

When did the patient start receiving radiation therapy as part of protocol treatment?

CL Item

Before Chemotherapy (Prior to chemotherapy)

CL Item

Post-chemotherapy (Post chemotherapy)

C0439577 (NCI Metathesaurus)

RTBeginDate

Item

Radiation Therapy Start Date (m/d/y)

date

C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C25431 (NCI Thesaurus Property)
C0439659 (UMLS 2011AA Property)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)

RTEndDate

Item

Radiation Therapy End Date (m/d/y)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
C25496 (NCI Thesaurus Property)
C2746065 (UMLS 2011AA Property)

RadiationTherapyBoostWholeBreastAdministeredInd-2

Item

Whole Breast, boost (Site All fields must be completed. - Irradiated? 1=no, 2=yes)

text

C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C12971 (NCI Thesaurus Property)
C0006141 (UMLS 2011AA Property)
C25326 (NCI Thesaurus Property)
C0444667 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25438 (NCI Thesaurus Property)
C1511253 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

CL.5

Code List

Whole Breast, boost (Site All fields must be completed. - Irradiated? 1=no, 2=yes)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

RadiationTherapyWholeBreastAdministeredInd-2

Item

Whole Breast, no boost

text

C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C12971 (NCI Thesaurus Property)
C0006141 (UMLS 2011AA Property)
C25326 (NCI Thesaurus Property)
C0444667 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

CL.6

Code List

Whole Breast, no boost

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

PartialBreastRadiationTherapyAdministeredInd-2

Item

Partial Breast

text

C12971 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)
C25378 (NCI Thesaurus ObjectClass)
C0728938 (UMLS 2011AA ObjectClass)
C15313 (NCI Thesaurus Property)
C1522449 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

CL.7

Code List

Partial Breast

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

ChestWallInvolvedInd-3

Item

Chest Wall (if mastectomy)

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL035093 (NCI Metathesaurus ObjectClass)
C25547 (NCI Thesaurus Property)

CL.8

Code List

Chest Wall (if mastectomy)

CL Item

No (NO)

CL Item

Yes (YES)

IpsilateralSupraclavicularRadiationTherapyAdministeredInd-2

Item

Ipsilateral Supraclavicular

text

C25329 (NCI Thesaurus ObjectClass)
C0589496 (UMLS 2011AA ObjectClass)
C25308 (NCI Thesaurus ObjectClass)
C0441989 (UMLS 2011AA ObjectClass)
C15313 (NCI Thesaurus Property)
C1522449 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

CL.9

Code List

Ipsilateral Supraclavicular

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

AxillaInvolvedInd-3

Item

Axilla

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C12674 (NCI Thesaurus ObjectClass)
C0004454 (UMLS 2011AA ObjectClass)
C25547 (NCI Thesaurus Property)

CL.10

Code List

Axilla

CL Item

No (NO)

CL Item

Yes (YES)

InternalMammaryLymphNodeInvolvedInd-3

Item

Internal Mammary Lymph Nodes

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25547 (NCI Thesaurus Property)
C32853 (NCI Thesaurus ObjectClass)
C0229755 (UMLS 2011AA ObjectClass)

CL.11

Code List

Internal Mammary Lymph Nodes

CL Item

No (NO)

CL Item

Yes (YES)

RadiationTherapyOtherLocationInd-2

Item

Other

text

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)

CL.12

Code List

Other

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

RadiationTherapySiteSpecify

Item

Other, specify (If)

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)

Whole Breast Irradiation

Item Group

Unnamed2

RadiationTherapyPriorBoostAdministeredTotalDose

Item

Total Dose Prior to Boost (Gy)

double

C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25438 (NCI Thesaurus Property)
C1511253 (UMLS 2011AA Property)
C25304 (NCI Thesaurus ValueDomain)
C0439810 (UMLS 2011AA ValueDomain)
C25488 (NCI Thesaurus ValueDomain)
C0178602 (UMLS 2011AA ValueDomain)

RadiationTherapyPriorBoostFractionationAdministeredCount

Item

Total Number of Fractions Prior to Boost

double

C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C15654 (NCI Thesaurus Property)
C0016640 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25438 (NCI Thesaurus Property)
C1511253 (UMLS 2011AA Property)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)

RadiationTherapyBoostAdministeredTotalDose

Item

RT Total Dose to Boost Field (If boost was given, complete the following: - Gy)

double

C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25438 (NCI Thesaurus Property)
C1511253 (UMLS 2011AA Property)
C25304 (NCI Thesaurus ValueDomain)
C0439810 (UMLS 2011AA ValueDomain)
C25488 (NCI Thesaurus ValueDomain)
C0178602 (UMLS 2011AA ValueDomain)

RTTotalFractionBoostCount

Item

Total Number of Fractions to Boost Field

double

C25304 (NCI Thesaurus Property)
C0439810 (UMLS 2011AA Property)
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C25514 (NCI Thesaurus Property)
C1264633 (UMLS 2011AA Property)

RTAdministeredTotalDose

Item

Total Dose of Radiation Therapy (PBI - Gy)

double

C25304 (NCI Thesaurus ValueDomain)
C0439810 (UMLS 2011AA ValueDomain)
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C25488 (NCI Thesaurus ValueDomain)
C0178602 (UMLS 2011AA ValueDomain)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)

Partial Breast Irradiation

Item Group

Partial Breast Irradiation

RadiationTherapyTotalFractionsCount

Item

Total Number of Fractions (PBI)

double

PartialBreastRadiationTherapyAdministeredPartialBreastRTType

Item

Method

text

C12971 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)
C25378 (NCI Thesaurus ObjectClass)
C0728938 (UMLS 2011AA ObjectClass)
C15313 (NCI Thesaurus Property)
C1522449 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)

CL.13

Code List

Method

CL Item

Mammosite Balloon Catheter (MammoSite Balloon Catheter)

CL Item

External Beam Radiation Therapy (External beam)

C15751 (NCI Thesaurus)
C1517033 (UMLS 2011AA)

CL Item

Intra-operative Radiation Therapy (Intraoperative)

CL Item

Other Brachytherapy (Other Brachytherapy)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

PartialBreastRadiationTherapyAdministeredSpecify

Item

Specify

text

C12971 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)
C25378 (NCI Thesaurus ObjectClass)
C0728938 (UMLS 2011AA ObjectClass)
C15313 (NCI Thesaurus Property)
C1522449 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)

RTAdministeredTotalDose

Item

Total Dose of Radiation Therapy (PBI - Gy)

double

PatientPartialBreastRadiationTherapyClinicalStudyParticipationType

Item

Is patient on Partial Breast Irradiation Protocol Study

text

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25608 (NCI Thesaurus Property)
C0679823 (UMLS 2011AA Property)
C15313 (NCI Thesaurus Property)
C1522449 (UMLS 2011AA Property)
C12971 (NCI Thesaurus Property)
C0006141 (UMLS 2011AA Property)
C25378 (NCI Thesaurus Property)
C0728938 (UMLS 2011AA Property)
C15206 (NCI Thesaurus Property)
C0008972 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)

CL.14

Code List

Is patient on Partial Breast Irradiation Protocol Study

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes, Nsabp B39 Or Rtog 0413 (Yes, NSABP B39 or RTOG 0413)

CL Item

Yes, Other (Yes, other)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

PatientPartialBreastRadiationTherapyClinicalStudyParticipationSpecify

Item

Other, specify

text

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25608 (NCI Thesaurus Property)
C0679823 (UMLS 2011AA Property)
C15313 (NCI Thesaurus Property)
C1522449 (UMLS 2011AA Property)
C12971 (NCI Thesaurus Property)
C0006141 (UMLS 2011AA Property)
C25378 (NCI Thesaurus Property)
C0728938 (UMLS 2011AA Property)
C15206 (NCI Thesaurus Property)
C0008972 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)

ResearchCommentsText

Item

Comments (Note: If the patient has bilateral breast cancer and received radiation therapy on both sides, only report the observed fractions for one side in the fields provided above. Add comments below providing the same information for the other side and state whether the right or left side is being reported below here in the comments)

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
C0282411 (UMLS 2011AA Property)

InvestigatorSignatureText

Item

Investigator Signature

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25678 (NCI Thesaurus Property)
C1519316 (UMLS 2011AA Property)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)

InvestigatorSignatureDate

Item

Investigator Signature Date

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25678 (NCI Thesaurus Property)
C1519316 (UMLS 2011AA Property)
C25367 (NCI Thesaurus ValueDomain)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)

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Breast Cancer NCT00433511 Treatment - E5103 Radiation Therapy Form - 2543728v1.0

Instructions: Complete this form according to the forms submission schedule. Submit original to the ECOG Coordinating Center; keep a copy for your files.

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