ID

2481

Description

CALGB-31004 OPEN Registration/Randomization Worksheet (SPARE Phase IB) Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=B5A21D41-B9DA-D92A-E040-BB89AD4353CA

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=B5A21D41-B9DA-D92A-E040-BB89AD4353CA

Keywords

Versions (3)
  1. 9/19/12 9/19/12 -
  2. 1/9/15 1/9/15 - Martin Dugas
  3. 1/9/15 1/9/15 - Martin Dugas
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September 19, 2012

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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Malignant Mesothelioma Registration - CALGB-31004 OPEN Registration/Randomization Worksheet (SPARE Phase IB) - 3342180v1.0

English

A Phase IB/Randomized Phase II Placebo-controlled Study of Linsitinib (OSI-906; NSC #751082) in Combination with Chemotherapy in Previously Treated Malignant Mesothelioma

1 forms  
Protocol Administration
Description

Protocol Administration

Date Informed Consent Signed (MM DD YYYY)
Description

InformedConsentFormSignedDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25367
NCI Thesaurus ObjectClass
C16468
UMLS 2011AA ObjectClass
C0009797
NCI Thesaurus Property
C25679
HIPAA Authorization Date (MM DD YYYY)
Description

PatientSignedDischargeMedicalRecordDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25679
NCI Metathesaurus Property
C0012621
NCI Thesaurus Property
C45258
UMLS 2011AA Property
C0025102
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Projected Start Date of Treatment (MM DD YYYY)
Description

TreatmentProjectedBeginDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass
C25631
NCI Thesaurus Property
C25431
UMLS 2011AA Property
C0439659
NCI Thesaurus Property
C25275
UMLS 2011AA Property
C2745955
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25431
UMLS 2011AA ValueDomain
C0439659
Pre-treatment Characteristics
Description

Pre-treatment Characteristics

Performance Status
Description

PerformanceStatusAssessmentEasternCooperativeOncologyGroupScale

Data type

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS 2011AA ValueDomain
C0349674
NCI Thesaurus Property
C25367
NCI Thesaurus ValueDomain
C25491
UMLS 2011AA ValueDomain
C1512162
NCI Thesaurus ObjectClass
C20641
UMLS 2011AA ObjectClass
C1518965
Height (cm)
Description

PatientHeightMeasurement

Data type

double

Measurement units
  • cm
Alias
NCI Thesaurus ValueDomain
C25209
UMLS 2011AA ValueDomain
C0242485
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25347
UMLS 2011AA Property
C0489786
cm
Weight (kg)
Description

PatientWeightMeasurement

Data type

double

Measurement units
  • Kg
Alias
NCI Thesaurus ValueDomain
C25209
UMLS 2011AA ValueDomain
C0242485
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25208
UMLS 2011AA Property
C0043100
Kg
Disease code (mesothelioma)
Description

MedicalDictionaryforRegulatoryActivitiesTerminologyIdentifierCode

Data type

double

Alias
NCI Thesaurus ValueDomain
C25162
UMLS 2011AA ValueDomain
C0805701
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Metathesaurus ObjectClass
CL104089
NCI Thesaurus ValueDomain
C43820
UMLS 2011AA ValueDomain
C1140263
Certification Of Eligibility
Description

Certification Of Eligibility

In the opinion of the investigator, is the patient eligible
Description

PatientEligibilityIndicator

Data type

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25171
UMLS 2011AA Property
C0013893
Prior Therapy
Description

Prior Therapy

Prior Cancer Therapies (Mark all that apply with an X.)
Description

PriorTherapyAdministeredType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C25629
UMLS 2011AA ObjectClass
C0332152
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Number of regimens (Chemotherapy multiple agents systemic)
Description

PriorMultipleAgentChemotherapyAdministeredCount

Data type

double

Alias
NCI Thesaurus ObjectClass
C15632
UMLS 2011AA ObjectClass
C0392920
NCI Thesaurus ObjectClass
C25629
UMLS 2011AA ObjectClass
C0332152
NCI Thesaurus ObjectClass
C17648
UMLS 2011AA ObjectClass
C0439064
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
Number of regimens (Chemotherapy non-cytotoxic)
Description

PriorNon-cytotoxicAgentChemotherapyAdministeredCount

Data type

double

Alias
NCI Thesaurus ObjectClass
C15632
UMLS 2011AA ObjectClass
C0392920
NCI Thesaurus ObjectClass
C25629
UMLS 2011AA ObjectClass
C0332152
NCI Thesaurus ObjectClass
C83487
UMLS 2011AA ObjectClass
C2827065
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
Number of regimens (Chemotherapy - NOS)
Description

PriorChemotherapyRegimenNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C15632
UMLS 2011AA ObjectClass
C0392920
NCI Thesaurus ObjectClass
C25629
UMLS 2011AA ObjectClass
C0332152
NCI Thesaurus Property
C15697
UMLS 2011AA Property
C0040808
Number of regimens (Chemotherapy single agent systemic)
Description

SingleAgentSystemicChemotherapyAdministeredCount

Data type

double

Alias
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
NCI Thesaurus ObjectClass
C15756
UMLS 2011AA ObjectClass
C0854619
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
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Similar models

A Phase IB/Randomized Phase II Placebo-controlled Study of Linsitinib (OSI-906; NSC #751082) in Combination with Chemotherapy in Previously Treated Malignant Mesothelioma

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Protocol Administration
InformedConsentFormSignedDate
Item
Date Informed Consent Signed (MM DD YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
C16468 (NCI Thesaurus ObjectClass)
C0009797 (UMLS 2011AA ObjectClass)
C25679 (NCI Thesaurus Property)
PatientSignedDischargeMedicalRecordDate
Item
HIPAA Authorization Date (MM DD YYYY)
date
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25679 (NCI Thesaurus Property)
C0012621 (NCI Metathesaurus Property)
C45258 (NCI Thesaurus Property)
C0025102 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
TreatmentProjectedBeginDate
Item
Projected Start Date of Treatment (MM DD YYYY)
date
C15368 (NCI Thesaurus ObjectClass)
C25631 (NCI Thesaurus 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)
C25431 (NCI Thesaurus ValueDomain)
C0439659 (UMLS 2011AA ValueDomain)
Item Group
Pre-treatment Characteristics
Item
Performance Status
text
C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus Property)
C25491 (NCI Thesaurus ValueDomain)
C1512162 (UMLS 2011AA ValueDomain)
C20641 (NCI Thesaurus ObjectClass)
C1518965 (UMLS 2011AA ObjectClass)
CL.1
Code List
Performance Status
CL Item
Fully Active, Able To Carry On All Pre-disease Performance Without Restriction. (0)
CL Item
Restricted In Physically Strenuous Activity But Ambulatory And Able To Carry Out Work Of A Light Or Sedentary Nature, E.g., Light Housework, Office Work. (1)
PatientHeightMeasurement
Item
Height (cm)
double
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25347 (NCI Thesaurus Property)
C0489786 (UMLS 2011AA Property)
PatientWeightMeasurement
Item
Weight (kg)
double
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25208 (NCI Thesaurus Property)
C0043100 (UMLS 2011AA Property)
Item
Disease code (mesothelioma)
double
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
CL104089 (NCI Metathesaurus ObjectClass)
C43820 (NCI Thesaurus ValueDomain)
C1140263 (UMLS 2011AA ValueDomain)
CL.2
Code List
Disease code (mesothelioma)
CL Item
Mesothelioma (10027410)
C3234 (NCI Thesaurus)
C0025500 (UMLS 2011AA)
Item Group
Certification Of Eligibility
Item
In the opinion of the investigator, is the patient eligible
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
CL.3
Code List
In the opinion of the investigator, is the patient eligible
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item Group
Prior Therapy
Item
Prior Cancer Therapies (Mark all that apply with an X.)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CL.4
Code List
Prior Cancer Therapies (Mark all that apply with an X.)
CL Item
No Previous Exposure To Drug (nos) (No prior therapy)
CL Item
Agents Administered To Control The Replication And/or Spread Of Viruses (Anti-retroviral therapy)
CL Item
Treatment With An Agent That Prevents Or Impairs The Translation Of The Genetic Message For Production Of A Specific Protein (Antisense)
CL Item
High Dose Chemotherapy Combined With Transplantation Of Bone Marrow Cells (Bone marrow transplant)
CL Item
Systemic Chemotherapy With A Regimen Containing Multiple Agents (Chemotherapy multiple agents systemic)
CL Item
Prior Therapy With Agents That Are Not Known To Cause Damage To Cycling Cells (Chemotherapy non-cytotoxic)
CL Item
Non-systemic Chemotherapy Treatment Or Chemotherapy Not Described By Chemotherapy Single Agent Systemic Or Multi-agent Systemic (Chemotherapy (NOS))
CL Item
Systemic Chemotherapy With A Single Agent Regimen (Chemotherapy single agent systemic)
CL Item
Treatment Of Human Disease By Gene Transfer (Gene transfer)
CL Item
Image Directed Local Therapy (Image Directed Local Therapy)
CL Item
Cancer Therapy Which Incorporates Hormonal Manipulation (Hormonal therapy)
CL Item
Drug And/or Immunotherapy (Drug and/or Immunotherapy)
CL Item
Anticancer Treatment With A Live, Replication-competent Virus (Oncolytic virotherapy)
CL Item
Targeted Ionizing Radiation Therapy Utilizing Radioactive Implants Or Seeds (Radiation therapy)
CL Item
Surgical Procedure, Or Operation, With Therapeutic Intent (Surgery)
CL Item
Therapy Nos (Therapy (NOS))
CL Item
Substance Or Group Of Substances Administered To Induce The Immune System To Recognize And Destroy Tumors Or Microorganisms (Vaccine)
CL Item
Hematopoietic Stem Cell Transplantation (Hematopoietic Stem Cell Transplantation)
PriorMultipleAgentChemotherapyAdministeredCount
Item
Number of regimens (Chemotherapy multiple agents systemic)
double
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C17648 (NCI Thesaurus ObjectClass)
C0439064 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
PriorNon-cytotoxicAgentChemotherapyAdministeredCount
Item
Number of regimens (Chemotherapy non-cytotoxic)
double
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C83487 (NCI Thesaurus ObjectClass)
C2827065 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
PriorChemotherapyRegimenNumber
Item
Number of regimens (Chemotherapy - NOS)
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C15697 (NCI Thesaurus Property)
C0040808 (UMLS 2011AA Property)
SingleAgentSystemicChemotherapyAdministeredCount
Item
Number of regimens (Chemotherapy single agent systemic)
double
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C15756 (NCI Thesaurus ObjectClass)
C0854619 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
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