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NSABP PROTOCOL C-08: REGISTRATION FORM Fluorouracil, Leucovorin, and Oxaliplatin With or Without Bevacizumab in Treating Patients Who Have Undergone Surgery for Stage II or Stage III Colon Cancer NCT00096278 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=D7F6865F-B506-428D-E034-0003BA12F5E7

Link:

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=D7F6865F-B506-428D-E034-0003BA12F5E7

Keywords:

Colorectal Neoplasms

Clinical Trial

Registration

Versions (4)

8/27/12 8/27/12 -
1/9/15 1/9/15 - Martin Dugas
3/22/15 3/22/15 - Martin Dugas
9/20/21 9/20/21 -

Uploaded on:

September 20, 2021

DOI:

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License :

Creative Commons BY-NC 3.0 Legacy

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Colon cancer (NSABP C-08 NCT00096278)

English 1

English

Details

Refer to patient entry guidelines in the Members' Area of the NSABP Web site.

1 forms

StudyEvent: NSABP PROTOCOL C-08: REGISTRATION FORM
1. Refer to patient entry guidelines in the Members' Area of the NSABP Web site.

Header

NSABP Patient ID

Patient Medical Record Number

Institution Name

Institution Number

Affiliate Name

Physician of Record (physician to whom subsequent vials will be sent must have a valid FDA number)

Date Informed Consent Signed (Month Day Year)

Person Completing Form Last Name

Person Completing Form First Name

Person Completing Form Phone

Person Completing Form Fax

Patient Initials (Last, First Middle)

Patient Social Security Number (USA only)

Race (more than one may be marked)

A Person Having Origins In Any Of The Original Peoples Of Europe, The Middle East, Or North Africa. (White)

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)

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 Original Peoples Of North And South America (including Central America), And Who Maintains Tribal Affiliation Or Community Attachment (American Indian or Alaska Native)

Patient Is Unsure Of Their Race (Unknown)

Method of Payment (mark primary method only)

Private Insurance (Private Insurance)

Medicare (Medicare)

Medicare And Private Insurance (Medicare & Private)

Medicaid (Medicaid)

8 more items in the detailed view.

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. (Non-Hispanic)

Patient Is Unsure Of Their Ethnicity (Unknown)

Country of Residence (if not USA)

Canada (Canada)

Australia (Australia)

Mexico (Mexico)

Other (Other)

Puerto Rico (Puerto Rico)

Patient's Zip Code (USA)

Performance Status

0 (Fully active, able to carry on all pre-disease performance without restriction (Karnofsky 90-100))

1 (Restricted in physically strenuous activity but ambulatory (K 70-80))

2 (Ambulatory and capable of all selfcare but unable to carry out any work activities (K 50-60))

3 (Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours (K 30-40))

6 more items in the detailed view.

Patient characteristics

Patient Height (cm)

Patient Weight (kg)

Patient Gender

Male (Male)

Female (Female)

Patient's Date of Birth (Month Day Year)

Date of Surgery (Month Day Year)

Date of Proposed Treatment (Month Day Year)

Lymph Nodes Number Examined

Lymph Nodes Number Positive

Blood Pressure Systolic (Report the Most Recent Blood Pressure)

Blood Pressure Diastolic (Report the Most Recent Blood Pressure)

Menopausal status (Females only)

Postmenopausal (1)

Premenopausal (2)

Serum Creatinine Patient Value

mg/dL

Serum Creatinine Upper Limit of Lab Normal (mg/dL)

mg/dL

Urine Protein/Creatinine Ratio

Date of Measurement (month day year)

Protein from 24 hour Urine Collection (g)

g/24 hours

Your blood and tissue samples may be kept by the NSABP for use in this study and future research to learn about, prevent, detect, or treat cancer.

Yes

Your blood and tissue samples may be used for research about other health problems (for example: causes of heart disease, osteoporosis, diabetes).

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

Your blood samples may be collected and sent to Genetech, Inc. for bevacizumab antibody testing.

Yes

C-08 Eligibility Checklist

Does the patient have psychiatric or addictive disorders that would preclude the patient from meeting the study requirements?

Yes

Has the patient authorized the release of Protected Health Information to the NSABP?

Yes

Has the patient consented to participate in this study and signed and dated an approved consent form?

Yes

Does the patient have a colon tumor that is other than adenocarcinoma?

Yes

Were there any isolated, distant, or non-contiguous intra-abdominal metastases (other than regional lymph nodes)?

Yes

Did the patient have an en bloc complete gross resection of tumor by open laparotomy or laparoscopically-assisted colectomy, i.e., curative resection?

Yes

Has the patient received any systemic therapy or surgery (other than a decompressive colostomy or en bloc resection of tumor) for the current colon cancer?

Yes

Is the distal extent of the lowest lying colon tumor greater or equal to 12 cm from the anal verge?

Yes

Does the patient have a histologically confirmed Stage II (T3, 4 N0 M0) or Stage III (any T N1,2 M0) tumor?

Yes

Is there postoperative evidence of adequate hepatic function as described in the protocol?

Yes

Are the postoperative absolute granulocyte count and platelet count within the criteria set by the protocol?

Yes

Is the patient's PT (INR) within the criteria set by the protocol?

Yes

Does the patient have significant peripheral neuropathy defined in the NCI CTCAE v3.0 as a grade 2 or greater neurosensory or neuromotor toxicity?

Yes

Has the patient had a major surgical procedure, open biopsy or significant traumatic injury within 28 days of entry, or is there anticipation of a need for major surgical procedure during the course of the study?

Yes

Does the patient have uncontrolled hypertension?

Yes

Has the patient had any prior malignancies in the past 5 years other than squamous or basal cell carcinoma of the skin, melanoma in situ, carcinoma in situ of the colon or rectum, or carcinoma in situ of the cervix that has been effectively treated?

Yes

Does the patient have Class III or Class IV cardiac disease or symptomatic arrhythmia

Yes

Does the patient have a history of myocardial infarction or unstable angina within the past 12 months

Yes

Does the patient have a prior history of TIA or CVA

Yes

Does the patient have a history of symptomatic peripheral vascular disease

Yes

Does the patient have a history of arterial thrombotic event within the past 12 months

Yes

Does the patient have a serious non-healing wound, skin ulcers or bone fracture?

Yes

Does the patient have active gastroduodenal ulcer(s) determined by endoscopy to be active?

Yes

Does the patient meet all other eligibility criteria?

Yes

In the opinion of the investigator, is the patient eligible?

Yes

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