Description:

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

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  1. 12/18/14
  2. 1/9/15
Uploaded on:

January 9, 2015

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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

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  1. StudyEvent: ACOSOG-Z4051 OPEN Registration Worksheet
    1. No Instruction available.
Patient Information
Gender of a Person
Ethnicity
Race
Method of Payment
General Information
Has patient previously been registered to an ACOSOG study
Was HIPAA Authorization included in Study Informed Consent
Eligibility Criteria
Age >= 18 years
ECOG Performance Status 0-1 (Zubrod)
ECOG Performance Status (Zubrod 0 or 1)
Biopsy-proven resectable primary (nonrecurrent) adenocarcinoma of the distal esophagus or GE junction (Siewert Type I or II)
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)
No definitive radiological evidence of distant metastases
No pre-existing grade 2 or greater peripheral neuropathy (CTCAE V3) of any etiology
WBC >= 3000/mm^3
ANC >= 1,500/mm^3
Hemoglobin >= 9.5 g/dL
Platelet count >= 100,000/mm^3
Creatinine <= 1.5 mg/dL
Total bilirubin <= 3 mg/dL
SGOT (AST) <= 2.0 times ULN
U/L
SGPT (ALT) <= 2.0 times ULN
Alkaline phosphatase <= 2.0 times ULN
Albumin >= 2.0 g/dL or prealbumin >= 15 mg/dL
Magnesium >= LLN
mmol/L
Patient must be evaluated before registration by medical oncologist, radiation oncologist and surgeon and deemed fit for protocol therapy and surgery
No prior invasive malignancy, unless disease-free for >= 5 years (Exceptions: non-melanoma skin cancer, in-situ cancers)
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)
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)
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
No history of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or any evidence of interstitial lung disease on baseline chest CT scan
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
Specimen Banking Consent
Patient has given permission to collect and keep blood specimens for use in this research study
Patient has given permission to collect and keep tissue specimens for use in this research study
Patient has given permission to keep blood and tissue specimens for use in future research to learn about, prevent or treat cancer
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)
Patient has given permission to keep blood and tissue specimens for use in future genetic research
Patient has given permission to be contacted in the future to take part in more research