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ACOSOG-Z4051 OPEN Registration Worksheet Panitumumab, Docetaxel, Cisplatin, Radiation Therapy, and Surgery in Treating Patients With Newly Diagnosed, Locally Advanced Esophageal Cancer or Cancer of the Gastroesophageal Junction Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=7FFA1514-8109-A58F-E040-BB89AD4376E5

Link:

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=7FFA1514-8109-A58F-E040-BB89AD4376E5

Keywords:

Esophageal Neoplasms

Clinical Trial

Registration

Versions (3)

12/18/14 12/18/14 - 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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Esophageal Cancer NCT00757172 Registration - ACOSOG-Z4051 OPEN Registration Worksheet - 3013492v1.0

English 1

English

Details

No Instruction available.

1 forms

StudyEvent: ACOSOG-Z4051 OPEN Registration Worksheet
1. No Instruction available.

Patient Information

Date of Birth (month day year)

Gender of a Person

Female Gender (Female Gender)

Male Gender (Male Gender)

Unknown (Unknown)

Ethnicity

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)

Not Provided Or Available (Not reported)

Country of Residence

Zip code

Race

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)

3 more items in the detailed view.

Method of Payment

Medicaid (Medicaid)

Medicaid And Medicare (Medicaid and Medicare)

Medicare (Medicare)

Medicare And Private Insurance (Medicare and Private Insurance)

8 more items in the detailed view.

General Information

Pt ID# (Local Patient Identifier)

Last (initial)

First (initial)

Middle (initial optional)

E-mail (for Registration Confirmation)

Has patient previously been registered to an ACOSOG study

Yes

Coordinating Group Patient ID (if yes previously issued ACOSOG Patient ID)

Date Informed Consent Signed (month day year)

Was HIPAA Authorization included in Study Informed Consent

Yes

HIPAA Authorization Date (If no month day year)

Eligibility Criteria

Age >= 18 years

Yes

ECOG Performance Status 0-1 (Zubrod)

Yes

ECOG Performance Status (Zubrod 0 or 1)

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)

Biopsy-proven resectable primary (nonrecurrent) adenocarcinoma of the distal esophagus or GE junction (Siewert Type I or II)

Yes

Pre-registration EUS, CT of chest and upper abdomen, and PET must support a clinical stage of T3N0M0, T2-3N1M0 or T2-3N0-1M1a (celiac adenopathy must be <=2 cm by EUS) (Clinically staged T1 tumors and T2N0M0 tumors are not eligible. N1 does not require biopsy/FNA. Note: Patients requiring a stent for nutrition must have staging examinations and scans completed before stent placement)

Yes

No definitive radiological evidence of distant metastases

Yes

No pre-existing grade 2 or greater peripheral neuropathy (CTCAE V3) of any etiology

Yes

WBC >= 3000/mm^3

Yes

WBC (>= 3000)

ANC >= 1,500/mm^3

Yes

ANC (>= 1500)

Hemoglobin >= 9.5 g/dL

Yes

Hemoglobin (>= 9.5)

Platelet count >= 100,000/mm^3

Yes

Platelet count (>= 100000)

Creatinine <= 1.5 mg/dL

Yes

Creatinine (<= 1.5)

Total bilirubin <= 3 mg/dL

Yes

Total Bilirubin (<= 3)

SGOT (AST) <= 2.0 times ULN

Yes

SGOT (AST) (<= 2.0 x ULN)

U/L

SGOT (AST) ULN

SGPT (ALT) <= 2.0 times ULN

Yes

SGPT (ALT) (<= 2.0 x ULN)

SGPT (ALT) ULN

Alkaline phosphatase <= 2.0 times ULN

Yes

Alkaline Phosphatase (<= 2.0 x ULN)

Alkaline Phosphatase ULN

Albumin >= 2.0 g/dL or prealbumin >= 15 mg/dL

Yes

Albumin (>= 2.0 OR)

Prealbumin (>= 15)

Magnesium >= LLN

Yes

Magnesium (>= LLN)

mmol/L

Magnesium, LLN

Patient must be evaluated before registration by medical oncologist, radiation oncologist and surgeon and deemed fit for protocol therapy and surgery

Yes

No prior invasive malignancy, unless disease-free for >= 5 years (Exceptions: non-melanoma skin cancer, in-situ cancers)

Yes

Non-pregnant and non-breast-feeding (Female participants of child-bearing potential must have a negative urine or serum pregnancy test prior to registration. Perimenopausal participants must be amenorrheic >= 12 months to be considered not of childbearing potential. All patients of reproductive potential must agree to use an effective method of birth-control while receiving study therapy and for six months after completion of therapy. If not a female of child-bearing potential or male check NA)

Yes (Yes)

No (No)

N/a (N/A)

Negative pregnancy test date (If female of child-bearing potential urine or serum mm/dd/yyyy)

No prior chest or upper abdomen radiotherapy; prior therapy with cisplatin, docetaxel, panitumumab or other anti-EGFR therapy; or prior esophageal or gastric surgery (Exception: prior surgery to treat reflux disease)

Yes

No uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Yes

No history of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or any evidence of interstitial lung disease on baseline chest CT scan

Yes

No history of any medical or psychiatric condition or laboratory abnormality that in the opinion of the investigator may increase the risks associated with the study participation or investigational product(s) administration or may interfere with the interpretation of the results

Yes

Specimen Banking Consent

Patient has given permission to collect and keep blood specimens for use in this research study

Yes

Patient has given permission to collect and keep tissue specimens for use in this research study

Yes

Patient has given permission to keep blood and tissue specimens for use in future research to learn about, prevent or treat cancer

Yes

Patient has given permission to keep blood and tissue specimens for use in future research to learn about, prevent or treat other health problems (for example: diabetes, Alzheimer's disease, or heart disease)

Yes

Patient has given permission to keep blood and tissue specimens for use in future genetic research

Yes

Patient has given permission to be contacted in the future to take part in more research

Yes

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