Description:

Z6051 Registration Worksheet (RW) NCT00726622 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=42C2D65A-ED39-4B6E-E044-0003BA3F9857

Link:

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=42C2D65A-ED39-4B6E-E044-0003BA3F9857

Keywords:
Versions (4) ▾
  1. 8/27/12
  2. 1/9/15
  3. 6/21/15
  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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Z6051 Registration Worksheet (RW) NCT00726622

No Instruction available.

  1. StudyEvent: Z6051 Registration Worksheet (RW)
    1. No Instruction available.
Header Module
Visit
Has patient previously been registered to an ACOSOG study
Pre-neoadjuvant Therapy Examination Data
cm
cm
Clinical T Stage
Clinical N Stage
Clinical M Stage
ECOG Performance Status (/Zubrod)
Pregnancy test done
Reason pregnancy test not performed
No concurrent or previous invasive pelvic malignancy (cervical, uterine and rectal) within five years prior to registration.
Neoadjuvant Therapy Date
Therapy received
Post-treatment exam done
Method of Evaluation (check all that apply)
cm
Footer Module
Patient Information
Gender
Race
Ethnicity
Method of Payment
Kg
cm
HIPAA Authorization form (OR)
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
Body Mass Index <= 34 (The same value applies to both male and female patients)
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 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.
No concurrent or previous invasive pelvic malignancy (cervical, uterine and rectal) within five years prior to registration.
Randomization
Randomization
Colorectal Surgical Procedure
Planned operative procedure
Site of primary tumor
Consent
My tissue specimens (if available) may be kept for use in future research to learn about, prevent, or treat cancer.
My tissue specimens (if available) may be kept for use in research to learn about, prevent, or treat other health problems (for example: diabetes, Alzheimer¿s disease, or heart disease).
My tissue specimens (if available) may be kept for use in future genetic research.

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