Description:

Z6051 - OPEN Enrollment Form Laparoscopic-Assisted Resection or Open Resection in Treating Patients With Stage IIA, Stage IIIA, or Stage IIIB Rectal Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=7AB13387-079D-04A4-E040-BB89AD4319A7

Link:

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=7AB13387-079D-04A4-E040-BB89AD4319A7

Keywords:
Versions (4) ▾
  1. 8/27/12
  2. 1/9/15
  3. 1/9/15
  4. 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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Colorectal Cancer NCT00726622 Registration - Z6051 - OPEN Enrollment Form - 2967118v1.0

Details

(Web site address for OPEN portal: http://open.ctsu.org/open/)

  1. StudyEvent: Z6051 - OPEN Enrollment Form
    1. (Web site address for OPEN portal: http://open.ctsu.org/open/)
Header Module
Specify Credits
Patient Information
Gender of a Person
Ethnicity
Race
3 more items in the detailed view.
Method of Payment
8 more items in the detailed view.
General Information
Was HIPAA Authorization included in Study Informed Consent (mark one)
Stratification Factors
Site of primary tumor
Planned operative procedure
Eligibility Criteria
Histologic diagnosis of adenocarcinoma of the rectum (<= 12cm from the anal verge)
T3N0M0, T1-3N1-2M0 disease as determined by pre-neoadjuvant therapy CT scans and pelvic MRI or transrectal ultrasound. Patients with T4 disease are not eligible
Completion of pre-operative 5FU-based chemotherapy and/or radiation therapy. Capecitabine may be substituted for 5FU.
Age >= 18 years
ECOG (Zubrod) Performance Status <= 2
ECOG Performance Status (Zubrod)
Body Mass Index <= 34 (NOTE: The same value applies to both male and female patients)
Kg
cm
No evidence of conditions that would preclude use of a laparoscopic approach (e.g., multiple previous major laparotomies, severe adhesions).
No systemic disease (cardiovascular, renal, hepatic, etc.) that would preclude surgery. No other severe incapacitating disease, i.e., ASA IV (a patient with severe systemic disease that is a constant threat to life) or ASA V (a moribund patient who is not expected to survive without the operation)
No concurrent or previous invasive pelvic malignancy (cervical, uterine and rectal) within five years prior to registration.
No history of psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements.
Amendment 4 Approval
Amendment 4 (dated August 15, 2011) IRB/REB approved
Specimen Collection And Banking Consent
Patient has given permission to keep tissue sample(s) for use in future research to learn about, prevent, or treat cancer.
Patient has given permission to keep tissue sample(s) for use in 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 tissue sample(s) for use in future genetic research.
Randomization
Randomization
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