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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:

Colorectal Neoplasms

Clinical Trial

Registration

Versions (4)

8/27/12 8/27/12 -
1/9/15 1/9/15 - Martin Dugas
1/9/15 1/9/15 - Martin Dugas
9/17/21 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

English 1

English

Details

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

1 forms

StudyEvent: Z6051 - OPEN Enrollment Form
1. (Web site address for OPEN portal: http://open.ctsu.org/open/)

Header Module

Institution CTEP ID

Institution Name

Protocol Number

Protocol Title

Registration Step

Treating Investigator (Add persons associated with this enrollment)

Specify Credits

Participating Group Code (Credit Specify Cooperative Group to receive enrollment credit)

Other Group Investigator Name (Credit Note: The Credit Investigator must be affiliated with the credited Cooperative Group and will be accountable for the patient and the site's responsibilities during a Cooperative Group Audit)

Comments (Enter case notes optional)

Patient Information

Date of Birth (month day year)

Gender of a Person

Female Gender (Female Gender)

Male Gender (Male Gender)

Unknown (Unknown)

Ethnicity

A Person Of Mexican, Puerto Rican, Cuban, Central Or South American Or Other Spanish Culture Or Origin, Regardless Of Race. (Hispanic or Latino)

A Person Not Meeting The Definition For Hispanic Or Latino. (Not Hispanic or Latino)

Not Provided Or Available (Not reported)

Country of Residence

Zip code

Race

A Person Having Origins In Any Of The Original Peoples Of North And South America (including Central America), And Who Maintains Tribal Affiliation Or Community Attachment. (American Indian or Alaska Native)

A Person Having Origins In Any Of The Original Peoples Of The Far East, Southeast Asia, Or The Indian Subcontinent Including, For Example, Cambodia, China, India, Japan, Korea, Malaysia, Pakistan, The Philippine Islands, Thailand, And Vietnam. (Asian)

A Person Having Origins In Any Of The Black Racial Groups Of Africa. Terms Such As "haitian" Or "negro" Can Be Used In Addition To "black Or African American." (Black or African American)

A Person Having Origins In Any Of The Original Peoples Of Hawaii, Guam, Samoa, Or Other Pacific Islands. (Native Hawaiian or other Pacific Islander)

3 more items in the detailed view.

Method of Payment

Medicaid (Medicaid)

Medicaid And Medicare (Medicaid and Medicare)

Medicare (Medicare)

Medicare And Private Insurance (Medicare and Private Insurance)

8 more items in the detailed view.

General Information

Pt ID# (Local Patient Identifier)

Last (initial)

First (initial)

Middle (initial optional)

E-mail (for Registration Confirmation)

Date Informed Consent Signed (month day year)

Was HIPAA Authorization included in Study Informed Consent (mark one)

Yes

HIPAA authorization date (If no, month day year)

Stratification Factors

Site of primary tumor

Z6051-f1-l1 (High rectum)

Z6051-f1-l2 (Middle rectum)

Z6051-f1-l3 (Low rectum)

Planned operative procedure

Z6051-f2-l1 (Low anterior resection)

Z6051-f2-l2 (Abdominal perineal resection)

Eligibility Criteria

Histologic diagnosis of adenocarcinoma of the rectum (<= 12cm from the anal verge)

Yes

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

Yes

Start Date of Neoadjuvant therapy

Date of CT Scan

Date of MRI/TRUS

End Date of Neoadjuvant therapy

Completion of pre-operative 5FU-based chemotherapy and/or radiation therapy. Capecitabine may be substituted for 5FU.

Yes

Age >= 18 years

Yes

ECOG (Zubrod) Performance Status <= 2

Yes

ECOG Performance Status (Zubrod)

Fully Active, Able To Carry On All Pre-disease Performance Without Restriction. (0)

Restricted In Physically Strenuous Activity But Ambulatory And Able To Carry Out Work Of A Light Or Sedentary Nature, E.g., Light Housework, Office Work. (1)

Ambulatory And Capable Of All Selfcare But Unable To Carry Out Any Work Activities. Up And About More Than 50% Of Waking Hours. (2)

Body Mass Index <= 34 (NOTE: The same value applies to both male and female patients)

Yes

Weight (kg)

Height (cm)

No evidence of conditions that would preclude use of a laparoscopic approach (e.g., multiple previous major laparotomies, severe adhesions).

Yes

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)

Yes

No concurrent or previous invasive pelvic malignancy (cervical, uterine and rectal) within five years prior to registration.

Yes

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.

Yes

Amendment 4 Approval

Amendment 4 (dated August 15, 2011) IRB/REB approved

Yes

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.

Yes

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).

Yes

Patient has given permission to keep tissue sample(s) for use in future genetic research.

Yes

Randomization

Open Laparotomy And Rectal Resection (Open laparotomy and rectal resection)

Laparoscopic-assisted Rectal Resection (Laparoscopic-assisted rectal resection)

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