Description:

8214: Registration Information Form Standard Therapy With or Without Surgery and Mitomycin C in Treating Patients With Advanced Limited Peritoneal Dissemination of Colon Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=618EF2EF-0953-F882-E040-BB89AD434C20

Link:

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=618EF2EF-0953-F882-E040-BB89AD434C20

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Versions (4) ▾
  1. 8/27/12
  2. 1/9/15
  3. 1/9/15
  4. 9/20/21
Uploaded on:

September 20, 2021

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License:
Creative Commons BY-NC 3.0 Legacy
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Colorectal Cancer NCT01167725 Eligibility - 8214: Registration Information Form - 2829956v1.0

No Instruction available.

  1. StudyEvent: 8214: Registration Information Form
    1. No Instruction available.
Header Module
Demography Section
Gender of a Person
Ethnicity
Race
Method of Payment
General Information
Was HIPAA Authorization included in Study Informed Consent
Eligibility Checklist
Mode of presentation of peritoneal surface dissemination of colon adenocarcinoma
ECOG Performance Status
Ability to measure peritoneal surface disease
Planned chemotherapy
Planned biologic therapy
Prior first-line therapy for advanced disease
Eligibility Criteria
Age >= 18 years
Capable of providing informed consent
The patient must have newly diagnosed, previously untreated, histopathologically or cytologically confirmed colon (not appendiceal or rectal) adenocarcinoma (not signet ring cell type) with synchronous or metachronous document limited peritoneal disease dissemination
Peritoneal Cancer Index (PCI) of 20 or less determined by helical CT scan +/- staging laparoscopy
No parenchymal hepatic metastases
No evidence of clinical (jaundice), biochemical (abnormally elevated serum bilirubin and/or alkaline phosphatase) or radiological (ultrasound, CT, or MR) biliary obstruction
No evidence of symptomatic malignant ascites requiring palliative paracentesis
Small volume of disease in the gastro-hepatic ligament defined by a <5 cm mass in the epigastric region on cross-sectional imaging
No cross sectional imaging findings indicative of multi-segmental (>1 site) small bowel obstruction, or small bowel loops matted together, or gross disease of the small bowel mesentery characterized by distortion, thickening or loss of mesenteric vascular clarity
No clinical or radiological evidence of hematogenous or distant nodal (retroperitoneal, pelvic, mediastinal, peri-portal or peri-aortic) metastasis
ECOG (Zubrod) performance status of 1 or less (Zubrod)
Absolute neutrophil count (ANC) >1200/mm3, white blood cell count (WBC) >4000/mm3 and platelet count >150,000/mm3
An international normalized ratio (INR) <= 1.5 (patients who are therapeutically anti-coagulated for unrelated medical conditions such as atrial fibrillation and whose anti-thrombotic treatment can be withheld for operation will be eligible)
Adequate hepatic function must be met as evidenced by total serum bilirubin <= 1.5 mg/dL (patients with total bilirubin >1.5 mg/dL eligible only with Gilbert's syndrome); alkaline phosphatase <2.5 times the upper limit of normal; and/or, SGOT (AST) <1.5 times upper limit of normal [alkaline phosphatase and SGOT (AST) cannot both exceed the upper limit of normal]
Is total bilirubin >1.5 mg/dL due to Gilbert's syndrome?
1000/uL
Alkaline phosphatase and AST cannot both exceed the upper limit of normal; select the test that does not exceed the upper limit of normal (check one)
Serum renal functional parameters, BUN and creatinine are within normal limits
Satisfactory cardiopulmonary function (no history of severe congestive heart failure or severe pulmonary disease, as indicated by clinically acceptable risks to undergo major abdominal-cytoreductive surgery).
No clinical history of acute myocardial infarction within six months of registration Patients who are status post revascularization procedures with satisfactory cardiac function are eligible
No significant history of a medical problem or co-morbidity that would preclude the patient from undergoing a major abdominal operation such as a history of severe congestive heart failure or active ischemic heart disease
No concurrent second malignancy requiring systemic therapy
Non-pregnant and non-lactating. Women of reproductive age must be willing to use contraception during study therapy. If not a woman of reproductive age (or male) (check NA)
No psychiatric or addictive disorders or other conditions that would preclude the patient from meeting the study requirements
No prior second-line systemic treatment for metastatic colon adenocarcinoma. Patients who received prior adjuvant therapy for colon adenocarcinoma and/or prior first-line systemic therapy for metastatic colon adenocarcinoma are eligible
Instructions
Patient has given permission to complete the Quality of Life questionnaires at the time points indicated
Your tissue, from surgery and intra-peritoneal chemotherapy (HIPEC), may be collected and used for the research study
Your blood may be collected and used for the research study
Your tissue samples may be kept by the USMCI Biospecimen Network for use in future research to learn about, prevent, detect, treat cancer
Your tissue samples may be used for research about other diseases
Your blood samples may be kept by the USMCI Biospecimen Network for use in future research to learn about, prevent, detect, treat cancer
Your blood samples may be used for research about other diseases
Your study doctor (or someone he or she chooses) may contact you in the future to ask you to take part in more research
Randomization
Randomization

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