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CALGB 80802 Registration Worksheet Form Sorafenib Tosylate With or Without Doxorubicin Hydrochloride in Treating Patients With Locally Advanced or Metastatic Liver Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=73B6D8AE-48AF-7324-E040-BB89AD43648A

Link:

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=73B6D8AE-48AF-7324-E040-BB89AD43648A

Keywords:

Clinical Trial

Liver Neoplasms

Registration

Versions (4)

9/19/12 9/19/12 -
1/9/15 1/9/15 - Martin Dugas
1/9/15 1/9/15 - Martin Dugas
9/17/21 9/17/21 -

Uploaded on:

September 17, 2021

DOI:

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License :

Creative Commons BY-NC 3.0 Legacy

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Liver Cancer NCT01015833 Registration - CALGB 80802 Registration Worksheet Form - 2940585v1.0

English 1

English

Details

A Randomized Phase III Trial to Evaluate the Potential Utility of a Genomic Prognostic Model to Identify Stage I Non-Small Cell Lung Cancer NSCLC) Patients as Candidates for Adjuvant Chemotherapy

1 forms

StudyEvent: CALGB 80802 Registration Worksheet Form
1. A Randomized Phase III Trial to Evaluate the Potential Utility of a Genomic Prognostic Model to Identify Stage I Non-Small Cell Lung Cancer NSCLC) Patients as Candidates for Adjuvant Chemotherapy

Header Module

Lead Institution

CALGB Patient ID (Assigned)

Institution/Affiliate

Participating Group Name

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

Male (MALE)

Female (FEMALE)

Patient Demographics/pre-treatment Characteristics2

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)

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)

BSA (m^2)

Method of Payment (USA only Mark one)

Medicaid (Medicaid)

Medicaid And Medicare (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

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

Hepatitis status

No Hepatitis (No hepatitis)

Hepatitis B (Hepatitis B)

Hepatitis C (Hepatitis C)

Hepatitis B And C (Hepatitis B and C)

Extent of disease

Locally Advanced (Locally advanced)

Metastatic (Metastatic)

Assigned Treatment Arm

Arm A: Doxorubicin Plus Sorafenib (Arm A: Doxorubicin plus Sorafenib)

Arm B: Sorafenib (Arm B: Sorafenib)

Protocol Design

Did the patient agree to participate in the CT imaging study

Yes

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

Yes

Patient's initial consent given for blood specimen use for genetic research on patient's cancer?

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 use for research unrelated to the patient's cancer?

Yes

Patient's initial consent given for further contact regarding specimen?

Yes

Registration Information

CALGB Patient ID (Assigned)

Registration Date (MM DD YYYY)

Participating Group Patient ID (Assigned)

Registrar's Signature

Notes:

CRA Name

CRA e-mail

CRA Phone

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