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CALGB 90802 Registration Worksheet Form Everolimus With or Without Bevacizumab in Treating Patients With Advanced Kidney Cancer That Progressed After First-Line Therapy Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=879626AD-DB8C-4AF2-E040-BB89AD4364E1

Link:

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=879626AD-DB8C-4AF2-E040-BB89AD4364E1

Keywords:

Clinical Trial

Registration

Kidney Neoplasms

Versions (4)

12/18/14 12/18/14 - Martin Dugas
1/9/15 1/9/15 - Martin Dugas
1/9/15 1/9/15 - Martin Dugas
9/20/21 9/20/21 -

Uploaded on:

September 20, 2021

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Creative Commons BY-NC 3.0 Legacy

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Kidney Cancer NCT01198158 Registration - CALGB 90802 Registration Worksheet Form - 3103555v1.0

English 1

English

Details

Randomized Phase III Trial Comparing Everolimus Plus Placebo Versus Everolimus Plus Bevacizumab for Advanced Renal Cell Carcinoma Progressing After Treatment with Tyrosine Kinase Inhibitors

1 forms

StudyEvent: CALGB 90802 Registration Worksheet Form
1. Randomized Phase III Trial Comparing Everolimus Plus Placebo Versus Everolimus Plus Bevacizumab for Advanced Renal Cell Carcinoma Progressing After Treatment with Tyrosine Kinase Inhibitors

Header Module

Lead Institution

Institution/Affiliate

Participating Group Name

CALGB Patient ID

Physician

Principal Investigator No.

Protocol Administration

IRB Approval Date (MM DD YYYY)

Date Informed Consent Signed (MM DD YYYY)

Projected Start Date of Treatment (MM DD YYYY)

HIPAA Authorization Date (MM DD YYYY)

Institution contact

Phone

Fax

Patient Demographics/pre-treatment Characteristics

Patient Initials (Last, First Middle)

Date of Birth (MM DD YYYY)

Patient Social Security Number

Patient Hospital No.

Gender

Female Gender (Female)

Male Gender (Male)

Race (Mark all that apply)

A Person Having Origins In Any Of The Original Peoples Of North And South America (including Central America), And Who Maintains Tribal Affiliation Or Community Attachment. (American Indian or Alaska Native)

A Person Having Origins In Any Of The Original Peoples Of The Far East, Southeast Asia, Or The Indian Subcontinent Including, For Example, Cambodia, China, India, Japan, Korea, Malaysia, Pakistan, The Philippine Islands, Thailand, And Vietnam. (Asian)

A Person Having Origins In Any Of The Black Racial Groups Of Africa. Terms Such As "haitian" Or "negro" Can Be Used In Addition To "black Or African American." (Black or African American)

A Person Having Origins In Any Of The Original Peoples Of Hawaii, Guam, Samoa, Or Other Pacific Islands. (Native Hawaiian or other Pacific Islander)

Could Not Be Determined Or Unsure (Unknown)

A Person Having Origins In Any Of The Original Peoples Of Europe, The Middle East, Or North Africa. (White)

Ethnicity (Mark one)

A Person Of Mexican, Puerto Rican, Cuban, Central Or South American Or Other Spanish Culture Or Origin, Regardless Of Race. (Hispanic or Latino)

A Person Not Meeting The Definition For Hispanic Or Latino. (Not Hispanic or Latino)

Could Not Be Determined Or Unsure (Unknown)

Patient Demographics/pre-treatment Characteristics2

Performance Status (ECOG/Zubrod scale)

Fully Active, Able To Carry On All Pre-disease Performance Without Restriction. (0)

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)

Ambulatory And Capable Of All Selfcare But Unable To Carry Out Any Work Activities. Up And About More Than 50% Of Waking Hours. (2)

Capable Of Only Limited Selfcare, Confined To Bed Or Chair More Than 50% Of Waking Hours. (3)

Completely Disabled. Cannot Carry On Any Selfcare. Totally Confined To Bed Or Chair. (4)

Dead (5)

Height (cm)

Weight (kg)

Body Surface Area (m^2)

Method of Payment (USA only Mark one)

Medicaid (Medicaid)

Medicare And Medicaid (Medicaid and Medicare)

Medicare (Medicare)

Medicare And Private Insurance (Medicare and Private Insurance)

7 more items in the detailed view.

Patient Demographics/pre-treatment Characteristics3

Disease (Renal cell carcinoma)

Stage (IV)

Pathologic type (Clear cell component)

Patient Zip Code

Country of Residence (If not USA)

Certification Of Eligibility And Protocol Design

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

Yes

Protocol Design

Stratification Factors (Number of risk factors present: The risk factors are: Karnofsky performance status <80%; Corrected serum calcium >10mg/dL; and Hb <13 for males and <11.5 for females. Mark one with an X. Zero risk factors One risk factor Two or three risk factors Total duration of prior VEGFR TKI Therapy Mark one with an X. <12 weeks of therapy >=12 weeks of therapy)

Assigned Treatment Arm

Kit number

Initial Patient Consent For Specimen Use

Patient's Initial Consent given for specimen use for research on the patient's cancer

Yes

Patient's initial consent given for specimen use for genetic research relating to the study treatment

Yes

Patient's Initial Consent given for specimen kept for future use in research to learn about, prevent, or treat cancer

Yes

Patient's initial consent given for specimen(s) may be kept for use in research to learn about, prevent, or treat other health problems (for example: diabetes, Alzheimer's disease, or heart disease)

Yes

My doctor or someone from CALGB may contact me in the future to ask me to take part in more research

Yes

Calgb 580902

Was the patient registered to CALGB 580902 (a companion to CALGB 90802)

Yes

Registration Information

Registration Date (MM DD YYYY)

Participating Group Patient ID