ID

6316

Description

RTOG-0412 S1: Post-Op Immunotherapy/RT Surgery Form Cisplatin and Docetaxel With or Without Radiation Therapy in Treating Patients Who Are Undergoing Surgery for Newly Diagnosed Stage III Non-Small Cell Lung Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=E4C3CDDF-D8AA-1A4C-E034-0003BA3F9857

Lien

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=E4C3CDDF-D8AA-1A4C-E034-0003BA3F9857

Mots-clés

18/12/2014 18/12/2014 - Martin Dugas
09/01/2015 09/01/2015 - Martin Dugas

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18 décembre 2014

DOI

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Licence

Creative Commons BY-NC 3.0 Legacy

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Lung Cancer NCT00113386 Treatment - RTOG-0412 S1: Post-Op Immunotherapy/RT Surgery Form - 2293382v3.0

model
Détails

Radiation Therapy Oncology Group Phase III Lung Pre-Op Chemotherapy vs. Pre-Op Concurrent Chemoradiation for NSCLC

1 Formulaires

StudyEvent: RTOG-0412 S1: Post-Op Immunotherapy/RT Surgery Form
1. Radiation Therapy Oncology Group Phase III Lung Pre-Op Chemotherapy vs. Pre-Op Concurrent Chemoradiation for NSCLC

Name

Type

Description | Question | Decode (Coded Value)

Type de données

Alias

MODULE 1

Item Group

Module 1

ProtocolRTOGIdentifierNumber

Item

RTOG Study

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C19778 (NCI Thesaurus Property)
C1514695 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)

Case#

Item

Case #

text

InstitutionName

Item

Institution

text

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

InstitutionIdentifierNumber

Item

Institution No.

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)

PatientInitialsName

Item

Participant's Initials

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)

PatientCoordinatingIdentifierNumber

Item

Participant's I.D. No.

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25462 (NCI Thesaurus Property)
C0700114 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)

DataAmendedInd-3

Item

AMENDED DATA (INSTRUCTIONS: This form is submitted on all surgically resected patients. Record dates as mm-dd-yyyy unless otherwise specified.)

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25416 (NCI Thesaurus Property)
C1691222 (UMLS 2011AA Property)

CL.1

Code List

AMENDED DATA (INSTRUCTIONS: This form is submitted on all surgically resected patients. Record dates as mm-dd-yyyy unless otherwise specified.)

CL Item

Yes (yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

SurgeryDate

Item

SURGERY DATE

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)

PrimarySurgeryType

Item

TYPE OF PRIMARY SURGERY

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)

CL.2

Code List

TYPE OF PRIMARY SURGERY

CL Item

Lobectomy (Lobectomy)

C15272 (NCI Thesaurus)
C0023928 (UMLS 2011AA)

CL Item

Bilobectomy (Bilobectomy)

CL Item

Sleeve Resection (Sleeve Resection)

CL Item

Pneumonectomy (Pneumonectomy)

C15305 (NCI Thesaurus)
C0032284 (UMLS 2011AA)

SurgeryDuration

Item

DURATION OF SURGERY (hour:minutes)

date

BloodLossAmount

Item

ESTIMATED BLOOD LOSS (cc)

double

C12434 (NCI Thesaurus ObjectClass)
C0229664 (UMLS 2011AA ObjectClass)
C25559 (NCI Thesaurus Property)
C1517945 (UMLS 2011AA Property)
C25417 (NCI Thesaurus ValueDomain)

WholeBloodTransfusionAdministeredUnitCount

Item

INTRAOP AND PERIOP (TRANSFUSIONS OF WHOLE BLOOD OR PACKED CELLS) (units)

double

C0370231 (NCI Metathesaurus ObjectClass)
C15408 (NCI Thesaurus ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C44278 (NCI Thesaurus ValueDomain)
C0439148 (UMLS 2011AA ValueDomain)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)

OtherTransfusionBloodAdministeredCount

Item

INTRAOP AND PERIOP (TRANSFUSIONS OF OTHER BLOOD PRODUCT) (units)

double

C17649 (NCI Thesaurus ObjectClass)
C0205394 (UMLS 2011AA ObjectClass)
C15408 (NCI Thesaurus ObjectClass)
C12434 (NCI Thesaurus Property)
C0229664 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)

SURGICAL PATHOLOGICAL RESULTS

Item Group

Surgical Pathological Results

SurgicalResectionNegativeFindingMarginPerformedInd-2

Item

R0 (all margins pathologically negative)

text

C25698 (NCI Thesaurus ObjectClass)
C15232 (NCI Thesaurus ObjectClass)
C0728940 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C38757 (NCI Thesaurus Property)
C1513916 (UMLS 2011AA Property)
C25563 (NCI Thesaurus Property)
C0205284 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

CL.3

Code List

R0 (all margins pathologically negative)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

SurgicalResectionMicroscopicPositiveFindingMarginPerformedInd-2

Item

R1 (microscopically positive margins or microscopic residual disease)

text

C25698 (NCI Thesaurus ObjectClass)
C15232 (NCI Thesaurus ObjectClass)
C0728940 (UMLS 2011AA ObjectClass)
C25252 (NCI Thesaurus Property)
C0205288 (UMLS 2011AA Property)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C38758 (NCI Thesaurus Property)
C1514241 (UMLS 2011AA Property)
C25563 (NCI Thesaurus Property)
C0205284 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

CL.4

Code List

R1 (microscopically positive margins or microscopic residual disease)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

SurgicalResectionGrossPositiveFindingMarginPerformedInd-2

Item

R2 (macroscopically positive margins or gross residual disease)

text

C25698 (NCI Thesaurus ObjectClass)
C15232 (NCI Thesaurus ObjectClass)
C0728940 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C38758 (NCI Thesaurus Property)
C1514241 (UMLS 2011AA Property)
C25563 (NCI Thesaurus Property)
C0205284 (UMLS 2011AA Property)
C43566 (NCI Thesaurus Property)
C0439806 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

CL.5

Code List

R2 (macroscopically positive margins or gross residual disease)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

LungTumorPathologicNStage

Item

N Stage, Pathologic (N0, N1, N2, N3)

text

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12468 (NCI Thesaurus ObjectClass)
C0024109 (UMLS 2011AA ObjectClass)
C25610 (NCI Thesaurus Property)
C1521733 (UMLS 2011AA Property)
C25580 (NCI Thesaurus Property)
C0456532 (UMLS 2011AA Property)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)

CL.6

Code List

N Stage, Pathologic (N0, N1, N2, N3)

CL Item

No (No)

CL Item

Yes (Yes)

CL Item

No Regional Lymph Node Metastasis (N0)

CL Item

Metastasis To Ipsilateral Peribronchial And/or Ipsilateral Hilar Lymph Nodes, And Intrapulmonary Nodes Including Involvement By Direct Extension Of The Primary Tumor (N1)

CL Item

Metastasis To Ipsilateral Mediastinal And/or Subcarinal Lymph Node(s) (N2)

CL Item

Metastasis To Contralateral Mediastinal, Contralateral Hilar, Ipsilateral Or Contralateral Scalene, Or Supraclavicular Lymph Node(s) (N3)

CL Item

Regional Lymph Nodes Cannot Be Assessed (NX)

LungTumorPathologicTStage

Item

T Stage, Pathologic (T1, T2, T3, T4)

text

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)

CL.7

Code List

T Stage, Pathologic (T1, T2, T3, T4)

CL Item

No (No)

CL Item

Yes (Yes)

CL Item

Tumor 3 Cm Or Less In Greatest Dimension, Surrounded By Lung Or Visceral Pleura, Invasion More Proximal Than The Lobar Bronchus, (i.e., Not In The Main Bronchus) (T1)

CL Item

Tumor Of Any Size That Directly Invades Any Of The Following: Chest Wall (including Superior Sulcus Tumors), Diaphragm, Mediastinal Pleura, Parietal Pericardium; Or Tumor In The Main Bronchus Less Than 2 Cm Distal To The Carina, But Without Involvement O* (T3)

CL Item

Tumor Of Any Size That Invades Any Of The Following: Mediastinum, Heart, Great Vessels, Trachea, Esophagus, Vertebral Body, Carina; Or Separate Tumor Nodules In The Same Lobe; Or Tumor With A Malignant Pleural Effusion (T4)

CL Item

Tumor With Any Of The Following Features Of Size Or Extent: More Than 3cm In Greatest Dimension; Invades The Visceral Pleura; Associated With Atelectasis Or Obstructive Pneumonitis That Extends To The Hilar Region But Does Not Involve The Entire Lung (T2)

LungLymphNodeInvolvedSite

Item

Lymph Node Type

text

C12468 (NCI Thesaurus ObjectClass)
C0024109 (UMLS 2011AA ObjectClass)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C25547 (NCI Thesaurus Property)
C13717 (NCI Thesaurus ValueDomain)
C1515974 (UMLS 2011AA ValueDomain)

CL.8

Code List

Lymph Node Type

CL Item

Highest Mediastinal (Highest Mediastinal)

CL Item

Right Upper Paratracheal Node (Right upper paratracheal)

CL Item

Left Upper Paratracheal Node (Left upper paratracheal)

CL Item

Pre And Retro Paratracheal Node (Pre and retro paratracheal)

CL Item

Right Lower Paratracheal Node (Right lower paratracheal)

CL Item

Left Lower Paratracheal Node (Left lower paratracheal)

CL Item

Subaortic Node (Subaortic)

CL Item

Para-aortic Node (Para-aortic)

CL Item

Subcarinal Node (Subcarinal)

CL Item

Paraesophageal Node (Paraesophageal)

CL Item

Pulmonary Ligament (Pulmonary ligament)

C0225794 (NCI Metathesaurus)

CL Item

Right Hilar Node (Right hilar)

CL Item

Left Hilar Node (Left hilar)

CL Item

Interlobar Node (Interlobar)

CL Item

Right Lobar Node (Right lobar)

CL Item

Left Lobar Node (Left lobar)

CL Item

Right Segmental Node (Right segmental)

CL Item

Left Segmental Node (Left segmental)

CL Item

Right Subsegmental Node (Right subsegmental)

CL Item

Left Subsegmental Node (Left subsegmental)

LymphNodeInvolvementType

Item

Lymph Node Involvement

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
C25547 (NCI Thesaurus Property)

CL.9

Code List

Lymph Node Involvement

CL Item

Not Evaluated (not evaluated)

CL Item

Positive (positive)

C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)

CL Item

Negative (negative)

C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)

CL Item

Equivocal (equivocal)

C86071 (NCI Thesaurus)
C0332241 (UMLS 2011AA)

CL Item

Unknown (unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

PatientVentilatorTreatmentDayCount

Item

NUMBER OF DAYS ON VENTILATOR

double

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus Property)
C38388 (NCI Thesaurus Property)
C0087153 (UMLS 2011AA Property)
C25301 (NCI Thesaurus ValueDomain)
C0439228 (UMLS 2011AA ValueDomain)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)

InpatientDischargeDate

Item

INPATIENT DISCHARGE DATE

date

PatientPost-OperativeHospitalizationDayCount

Item

NUMBER OF POST-OPERATIVE DAYS TO TIME OF DISCHARGE

double

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25623 (NCI Thesaurus Property)
C25179 (NCI Thesaurus Property)
C0019993 (UMLS 2011AA Property)
C25301 (NCI Thesaurus ValueDomain)
C0439228 (UMLS 2011AA ValueDomain)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)

CommonToxicityCriteriaAdverseEventGrade

Item

SEVERITY GRADE

double

C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C18000 (NCI Thesaurus ValueDomain)
C0919553 (UMLS 2011AA ValueDomain)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)

CommonToxicityCriteriaAdverseEventTermType

Item

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C45559 (NCI Thesaurus Property)
C1705313 (UMLS 2011AA Property)

CL.10

Code List

CL Item

Prolonged Chest Tube Drainage Or Air Leak After Pulmonary Resection (Prolonged chest tube drainage or air leak after pulmonary resection)

CL Item

Pneumonitis Nos (PNEUMONITIS/PULMONARY INFILTRATES)

CL Item

Culture Wound Positive (INFECTION (WOUND))

C0476436 (NCI Metathesaurus)

CL Item

Atelectasis (ATELECTASIS)

C2888 (NCI Thesaurus)
C0004144 (UMLS 2011AA)

CL Item

Pneumothorax Nos (PNEUMOTHORAX)

C0032326 (NCI Metathesaurus)

CL Item

Chylothorax (CHYLOTHORAX)

C0008733 (NCI Metathesaurus)

CL Item

Myocardial Ischaemia (CARDIAC ISCHEMIA/INFARCTION)

C0151744 (NCI Metathesaurus)

CL Item

Thrombosis Nos (THROMBOSIS/EMBOLISM (PULMONARY))

CL Item

Supraventricular Arrhythmia Nos (SUPRAVENTRICULAR ARRHYTHMIA (ATRIAL))

CL Item

Post-operative Haemorrhage (HEMORRHAGE (POST-OPERATIVE))

CL Item

Fistula, Pulmonary/upper Respiratory (FISTULA PULMONARY/UPPER RESPIRATORY)

CL Item

Pleural Effusion (PLEURAL EFFUSION)

C3331 (NCI Thesaurus)
C0021071 (UMLS 2011AA)

CL Item

Death Not Associated With Ctcae Term (DEATH)

AdverseEventAssessmentDate

Item

Adverse Event Assessment Date

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C25367 (NCI Thesaurus ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)

ResearchCommentsText

Item

COMMENTS

text

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

SurgeonSignatureText

Item

Signature of surgeon

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25678 (NCI Thesaurus Property)
C1519316 (UMLS 2011AA Property)
C18071 (NCI Thesaurus ObjectClass)
C0582175 (UMLS 2011AA ObjectClass)

ResponsiblePersonName

Item

Name of person completing form

text

C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25657 (NCI Thesaurus ObjectClass)
C1273518 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)

FormOriginalCompleteDate

Item

Form completion date, original

date

C19464 (NCI Thesaurus ObjectClass)
C0376315 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C25604 (NCI Thesaurus Property)
C0205313 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)

CHECKATTACHMENTS

Item

CHECK ATTACHMENTS

text

CL.11

Code List

CHECK ATTACHMENTS

CL Item

SURGICAL REPORT(S2) (SURGICAL REPORT(S2))

CL Item

RESECTION PATHOLOGY REPORT(S5) (RESECTION PATHOLOGY REPORT(S5))

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Lung Cancer NCT00113386 Treatment - RTOG-0412 S1: Post-Op Immunotherapy/RT Surgery Form - 2293382v3.0

Radiation Therapy Oncology Group Phase III Lung Pre-Op Chemotherapy vs. Pre-Op Concurrent Chemoradiation for NSCLC

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