Description:

ACOSOG-Z4051 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=6F3CD617-2357-8015-E040-BB89AD43783A

Link:

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=6F3CD617-2357-8015-E040-BB89AD43783A

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January 9, 2015

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Creative Commons BY-NC 3.0 Legacy
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Esophageal Cancer NCT00757172 Registration - ACOSOG-Z4051 Registration Worksheet - 2921081v1.0

Each eligibility criterion must be evaluated and documented in the patient's medical record. No eligibility exemptions or waivers will be permitted

Header Module
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Eligibility Criteria
Age >= 18 years
ECOG Performance Status 0-1 (Zubrod)
Biopsy-proven resectable primary (nonrecurrent) adenocarcinoma of the distal esophagus or GE junction (Siewert Type I or II) (Siewert Type definitions: Siewert Type I: adenocarcinoma of the distal esophagus Siewert Type II: adenocarcinoma of the esophago-gastric junction/real cardia)
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)
No definitive radiological evidence of distant metastases
No pre-existing grade 2 or greater peripheral neuropathy of any etiology
Adequate bone marrow, hepatic and renal function prior to registration (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 AST SGOT <= 2.0 times ULN ALT SGPT <= 2.0 times ULN Alkaline phosphatase <= 2.0 times ULN Albumin >= 2.0 g/dL or prealbumin >= 15 mg/dL Magnesium >= LLN)
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 childbearing potential must have a negative urine or serum pregnancy test <= 14 days 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)
No history of prior EGFR targeted therapy or therapy for pancreatic cancer or active infection requiring intravenous antibiotics at the time of registration
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
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
Smoking Status
Have you smoked at least 100 cigarettes in your entire life? (check one)
Do you now smoke cigarettes? (smoked in the past 30 days check one)
Cigar (Have you used any other tobacco products at least 100 times in your lifetime)
Pipe (Have you used any other tobacco products at least 100 times in your lifetime)
Snuff (Have you used any other tobacco products at least 100 times in your lifetime)
Chewing tobacco (Have you used any other tobacco products at least 100 times in your lifetime)
Other (Have you used any other tobacco products at least 100 times in your lifetime)
Laboratory Values
g/dL
1000/uL
U/L
mmol/L
Pregnancy Test
Pregnancy test done (check one)
Reason pregnancy test not performed (If No, check one)
Pre-treatment Staging
Siewert Type (check one)
CT evidence of tumor invasion into adjacent structures (check one)
CT suspicious for pulmonary metastases (check one)
CT suspicious for liver metastases (check one)
Biopsy done (If Yes, check one)
CT nodal enlargement (check one)
Nodal Sites (If Yes, indicate check all that apply)
Pre-treatment Staging1
Uptake in LN or other sites (check one)
Maximum depth of tumor invasion (check one)
Biopsy done (If Yes, check one)
Nodes biopsied (check one)
Biopsy Result (If Yes, indicate)
Pre-treatment Staging2
Clinical T Stage
Clinical N Stage
Clinical M Stage