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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

Keywords:

Colorectal Neoplasms

Clinical Trial

Eligibility Determination

Versions (4)

8/27/12 8/27/12 -
1/9/15 1/9/15 - Martin Dugas
1/9/15 1/9/15 - Martin Dugas
9/20/21 9/20/21 -

Uploaded on:

September 20, 2021

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Creative Commons BY-NC 3.0 Legacy

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Colorectal Cancer NCT01167725 Eligibility - 8214: Registration Information Form - 2829956v1.0

English 1

English

Details

No Instruction available.

1 forms

StudyEvent: 8214: Registration Information Form
1. No Instruction available.

Header Module

Institution CTEP ID

Institution Name

Protocol Number

Protocol Title

Registration Step

Treating Investigator

Credited Group or Organization

Investigator (Credit - Note: The Credit Investigator must be affiliated with the credited Group or Organization and will be accountable for the patient and the site¿s responsibilities during Audit.)

Comments (Enter case notes optional)

Demography Section

Date of Birth

Gender of a Person

Female Gender (Female)

Male Gender (Male)

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#

Last

First

Middle

Date Informed Consent Signed

Was HIPAA Authorization included in Study Informed Consent

Yes

HIPAA Authorization Date

Eligibility Checklist

Mode of presentation of peritoneal surface dissemination of colon adenocarcinoma

Synchronous (Synchronous)

Metachronous (Metachronous)

ECOG Performance Status

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)

Ability to measure peritoneal surface disease

Measurable: Peritoneal Surface Disease Apparent On Cross Sectional Imaging (Measurable: peritoneal surface disease apparent on cross sectional imaging)

Non-measurable: Peritoneal Surface Disease Unapparent On Cross Sectional Imaging (Non-measurable: peritoneal surface disease unapparent on cross sectional imaging)

Planned chemotherapy

Oxaliplatin Based Therapy (Oxaliplatin based therapy)

Irinotecan-based Therapy (Irinotecan-based therapy)

5-fu/lv-capecitabine Alone (5-FU/LV-capecitabine alone)

Planned biologic therapy

Bevacizumab (Bevacizumab)

Cetuximab (Cetuximab)

No Biologic Therapy (No biologic therapy)

Prior first-line therapy for advanced disease

Chemo Naive (Chemo Naive)

Prior First-line Therapy (Prior First-Line Therapy)

Eligibility Criteria

Age >= 18 years

Yes

Capable of providing informed consent

Yes

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

Yes

Peritoneal Cancer Index (PCI) of 20 or less determined by helical CT scan +/- staging laparoscopy

Yes

PCI score

No parenchymal hepatic metastases

Yes

No evidence of clinical (jaundice), biochemical (abnormally elevated serum bilirubin and/or alkaline phosphatase) or radiological (ultrasound, CT, or MR) biliary obstruction

Yes

No evidence of symptomatic malignant ascites requiring palliative paracentesis

Yes

Small volume of disease in the gastro-hepatic ligament defined by a <5 cm mass in the epigastric region on cross-sectional imaging

Yes

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

Yes

No clinical or radiological evidence of hematogenous or distant nodal (retroperitoneal, pelvic, mediastinal, peri-portal or peri-aortic) metastasis

Yes

ECOG (Zubrod) performance status of 1 or less (Zubrod)

Yes

Absolute neutrophil count (ANC) >1200/mm3, white blood cell count (WBC) >4000/mm3 and platelet count >150,000/mm3

Yes

ANC

WBC

Platelet count

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)

Yes

INR

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]

Yes

Is total bilirubin >1.5 mg/dL due to Gilbert's syndrome?

Yes

Total Bilirubin

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)

Alkaline Phosphatase (Alkaline Phosphatase)

Sgot (ast) (SGOT (AST))

Both Alkaline Phosphatase And Sgot (ast) (Both Alkaline Phosphatase and SGOT (AST))

Alkaline Phosphatase

Alkaline Phosphatase ULN

SGOT (AST)

SGOT (AST) ULN

Serum renal functional parameters, BUN and creatinine are within normal limits

Yes

BUN

BUN LNL

BUN ULN

Creatinine

Creatinine LLN

Creatinine ULN

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).

Yes

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

Yes

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

Yes

No concurrent second malignancy requiring systemic therapy

Yes

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)

Yes (Yes)

No (No)

N/a (N/A)

No psychiatric or addictive disorders or other conditions that would preclude the patient from meeting the study requirements

Yes

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

Yes

Instructions

Patient has given permission to complete the Quality of Life questionnaires at the time points indicated

Yes

Your tissue, from surgery and intra-peritoneal chemotherapy (HIPEC), may be collected and used for the research study

Yes

Your blood may be collected and used for the research study

Yes

Your tissue samples may be kept by the USMCI Biospecimen Network for use in future research to learn about, prevent, detect, treat cancer

Yes

Your tissue samples may be used for research about other diseases

Yes

Your blood samples may be kept by the USMCI Biospecimen Network for use in future research to learn about, prevent, detect, treat cancer

Yes

Your blood samples may be used for research about other diseases

Yes

Your study doctor (or someone he or she chooses) may contact you in the future to ask you to take part in more research

Yes

Randomization

Systemic Therapy (Systemic Therapy)

Crs/hipec & System Therapy (CRS/HIPEC & System Therapy)

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